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dalteparin

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Description

Dalteparin: A low-molecular-weight fragment of heparin, prepared by nitrous acid depolymerization of porcine mucosal heparin. The mean molecular weight is 4000-6000 daltons. It is used therapeutically as an antithrombotic agent. (From Merck Index, 11th ed) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID772
SCHEMBL ID543122
MeSH IDM0027162

Synonyms (105)

Synonym
sublingula
heparina [inn-spanish]
vitrum ab
liquaemin
cy 216
kb 101
depo-heparin
nadroparin
op 622
pabyrin
lipo-hepin
novoheparin
parnaparin
fragmin
vetren
fluxum
heparinum [inn-latin]
thromboliquine
fraxiparin
alpha-heparin
clexane
heparine [inn-french]
cy 222
op 386
sandoparin
einecs 232-681-7
hed-heparin
lmwh
fragmin b
heparinate
fr 860
hepathrom
fragmin a
clivarin
eparina [dcit]
liquemin
parvoparin
multiparin
clivarine
hsdb 3094
heparin cy 216
pk-10169
lovenox
heparinic acid
arteven
heparin sulfate
bemiparin
enoxaparin
pularin
reviparin
certoparin
dalteparin
tinzaparin
ardeparin
rp-54563
2-o-sulfohexopyranuronosyl-(1->4)-2-deoxy-3-o-sulfo-2-(sulfoamino)hexopyranosyl-(1->4)-2-o-sulfohexopyranuronosyl-(1->4)-2-acetamido-2-deoxy-6-o-sulfohexopyranose
nadroparine
ave-5026
M118 ,
heparin [ban]
s79o08v79f ,
unii-p776jq4r2f
unii-v72ot3k19i
v72ot3k19i ,
m316wt19d8 ,
m 118reh
heparine
vl0l558gcb ,
triofiban
7uq7x4y489 ,
subeparin
4qw4an84nq ,
1k5kdi46kz ,
eparina
octaparin
9816xa9004 ,
m 118
adomiparin
unii-e47c0nf7lv
t2410km04a ,
heparina
unii-4qw4an84nq
unii-t2410km04a
5r0l1d739e ,
unii-1k5kdi46kz
adomiparin [usan]
unii-vl0l558gcb
semuloparin [usan:inn]
heparinum
unii-s79o08v79f
unii-7uq7x4y489
semuloparin
e47c0nf7lv ,
unii-5r0l1d739e
unii-9816xa9004
p776jq4r2f ,
unii-m316wt19d8
6-[5-acetamido-4,6-dihydroxy-2-(sulfooxymethyl)oxan-3-yl]oxy-3-[5-(6-carboxy-4,5-dihydroxy-3-sulfooxyoxan-2-yl)oxy-6-(hydroxymethyl)-3-(sulfoamino)-4-sulfooxyoxan-2-yl]oxy-4-hydroxy-5-sulfooxyoxane-2-carboxylic acid
gtpl6811
SCHEMBL543122
DTXSID80872762
6-[6-[6-[5-acetamido-4,6-dihydroxy-2-(sulfooxymethyl)tetrahydropyran-3-yl]oxy-2-carboxy-4-hydroxy-5-sulfooxy-tetrahydropyran-3-yl]oxy-2-(hydroxymethyl)-5-(sulfoamino)-4-sulfooxy-tetrahydropyran-3-yl]oxy-3,4-dihydroxy-5-sulfooxy-tetrahydropyran-2-carboxyli
AKOS032944890
Q416516
BCP13334

Research Excerpts

Overview

Dalteparin sodium (DS) is a low-molecular-weight heparin with a mean molecular weight of 5,000. It is an LMWH indicated for patients undergoing abdominal surgery who are considered to be at risk for deep-vein thrombosis (DVT), which may lead to pulmonary embolism (PE)

ExcerptReferenceRelevance
"Dalteparin is an important FDA-approved treatment for pediatric VTE, particularly with cancer."( A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer.
Goldenberg, NA; Hartman, LR; Jani, D; Nurmeev, I; Sherman, N; Svirin, P; Wolter, KD; Yan, JL, 2022
)
1.68
"Dalteparin is a safe and effective anticoagulant when used for paediatric home HD. "( Dalteparin anticoagulation in paediatric home haemodialysis.
Hothi, DK; Lutkin, M; Stronach, L; Yadav, P, 2018
)
3.37
"Dalteparin is a safe and effective anticoagulant for patients on high-flux HD and HDF. "( Dalteparin dosing in high-flux haemodialysis and haemodiafiltration.
Berdeprado, J; Farrington, K; Sivalingam, M; Sridharan, S, 2012
)
3.26
"Dalteparin is a commonly used low molecular weight heparin (LMWH) with extensive safety data in adults. "( A retrospective analysis of outcomes of dalteparin use in pediatric patients: a single institution experience.
Graner, K; Mullikin, T; Pruthi, RK; Rao, AN; Rodriguez, V; Shaughnessy, WJ; Warad, D, 2015
)
2.13
"Dalteparin sodium (DS) is a low-molecular-weight heparin with a mean molecular weight of 5,000."( Dalteparin sodium prevents liver injury due to lipopolysaccharide in rat through suppression of tumor necrosis factor-alpha production by Kupffer cells.
Enomoto, N; Hirose, M; Ikejima, K; Kitamura, T; Sato, N; Takei, Y; Tsukada, S, 2003
)
2.48
"Dalteparin is a low molecular weight heparin (LMWH) with a mean molecular weight of approximately 5,000. "( Dalteparin: pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic diseases.
Hull, RD; Pineo, GF, 2004
)
3.21
"Dalteparin appeared to be a safe, effective means of short-term thromboembolic prophylaxis in this population of ambulatory male veterans with mechanical heart valves. "( Safety of outpatient dalteparin therapy in veterans with mechanical heart valves.
Copeland, LA; Flanagan, PS; O'Neill, JL; Zaleon, CR, 2005
)
2.09
"Dalteparin is an LMWH indicated for patients undergoing abdominal surgery who are considered to be at risk for deep-vein thrombosis (DVT), which may lead to pulmonary embolism (PE). "( Dalteparin: a low-molecular-weight heparin.
Howard, PA, 1997
)
3.18
"Dalteparin proved to be an effective and well tolerated drug for prophylaxis and therapy of thrombosis in pediatric patients. "( The low molecular weight heparin dalteparin for prophylaxis and therapy of thrombosis in childhood: a report on 48 cases.
Auberger, K; Flemmer, A; Nohe, N; Praun, M; Rümler, R, 1999
)
2.03
"Dalteparin is a low molecular weight heparin (LMWH) with a mean molecular weight of 5000. "( Dalteparin: an update of its pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic disease.
Dunn, CJ; Jarvis, B, 2000
)
3.19
"Dalteparin is a low molecular weight heparin (LMWH) recently approved for treatment of unstable angina and non-Q wave myocardial infarction (NQWMI)."( Dalteparin for acute coronary syndromes.
O'Loughlin, DC,
)
2.3

Effects

Dalteparin sodium has been subjected to a large number of well-designed randomised clinical trials for the prevention and treatment of thrombotic disorders. It has shown minimal tendency to accumulate in patients with CKD and may be safe to use in this patient population.

ExcerptReferenceRelevance
"Dalteparin has a predictable dose response and can be administered as a standard single daily subcutaneous dose for all patients."( Dalteparin: a low-molecular-weight heparin.
Howard, PA, 1997
)
2.46
"Dalteparin, however, has shown minimal tendency to accumulate in patients with CKD and may be safe to use in this patient population."( Treatment with Dalteparin is Associated with a Lower Risk of Bleeding Compared to Treatment with Unfractionated Heparin in Patients with Renal Insufficiency.
Billett, HH; Calvo, M; Kushnir, M; Park, D; Sinnet, M; Solorzano, C; Southern, W, 2016
)
1.51
"Dalteparin has been subjected to a large number of well designed randomised clinical trials for the prevention and treatment of venous thromboembolism."( Dalteparin: pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic diseases.
Hull, RD; Pineo, GF, 2004
)
2.49
"Dalteparin sodium has also shown clinical benefit in the management of patients with unstable angina or non-Q-wave myocardial infarction."( Dalteparin sodium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders.
Dunn, CJ; Sorkin, EM, 1996
)
2.46
"Dalteparin has a predictable dose response and can be administered as a standard single daily subcutaneous dose for all patients."( Dalteparin: a low-molecular-weight heparin.
Howard, PA, 1997
)
2.46
"Dalteparin also has less lipolytic activity than UFH."( Dalteparin: an update of its pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic disease.
Dunn, CJ; Jarvis, B, 2000
)
2.47
"Dalteparin sodium has been subjected to a large number of well-designed randomised clinical trials for the prevention and treatment of thrombotic disorders."( Dalteparin sodium.
Hull, RD; Pineo, GF, 2001
)
2.47

Actions

Dalteparin induced an increase in C(max) and AUC(0 - infinity) values of free TFPI in the two groups with renal insufficiency.

ExcerptReferenceRelevance
"Dalteparin may inhibit atherosclerotic lesions by downregulating the expression of LOX-1 protein."( Effect of dalteparin on atherosclerotic lesion formation in apolipoprotein E-deficient mice.
Bao, H; Chen, D; Li, W; Miao, Y; Su, L; Yan, Z; Zhang, Q, 2015
)
1.54
"Dalteparin induced an increase in C(max) and AUC(0 - infinity) values of free TFPI in the two groups with renal insufficiency that was higher than in healthy volunteers."( Evaluation of the pharmacokinetics of dalteparin in patients with renal insufficiency.
Achenbach, H; Preiss, C; Preiss, R; Siegemund, A; Stöbe, J, 2006
)
1.33
"Dalteparin, at a lower dose, was compared with placebo during the following 39 days."( Fragmin in unstable angina pectoris or in non-Q-wave acute myocardial infarction (the FRIC study). Fragmin in Unstable Coronary Artery Disease.
Buchwald, A; Hillis, WS; Klein, W; Ludwig, K; Monrad, S; Olaisson, E; Sanz, G; Turpie, AG; Undeland, S; van der Meer, J, 1997
)
1.02

Treatment

Dalteparin-treated patients were significantly less likely to experience a major bleed than patients treated with UFH (1.14% vs. 1.7%). Daltepin treatment significantly reduces LV thrombus formation in acute anterior MI but is associated with increased hemorrhagic risk.

ExcerptReferenceRelevance
"In dalteparin-treated patients, delta vWf was elevated (+48 +/- 8%) and did not differ from the unfractionated heparin group (NS)."( Effects of various anticoagulant treatments on von Willebrand factor release in unstable angina.
Ankri, A; Choussat, R; Collet, JP; Drobinski, G; Lison, L; Montalescot, G; Perlemuter, K; Philippe, F; Thomas, D; Vicaut, E, 2000
)
0.82
"Dalteparin treatment reduced system A and system L activity under normoxic conditions and ASA (1 mM) decreased system A and L transporter activity under normoxic and hypoxic conditions."( Hypoxia and the anticoagulants dalteparin and acetylsalicylic acid affect human placental amino acid transport.
Darashchonak, N; Erlenwein, SV; Kleppa, MJ; von Kaisenberg, CS; von Versen-Höynck, F, 2014
)
1.41
"Dalteparin-treated patients were significantly less likely to experience a major bleed than patients treated with UFH (1.14 % vs. "( Treatment with Dalteparin is Associated with a Lower Risk of Bleeding Compared to Treatment with Unfractionated Heparin in Patients with Renal Insufficiency.
Billett, HH; Calvo, M; Kushnir, M; Park, D; Sinnet, M; Solorzano, C; Southern, W, 2016
)
2.23
"The dalteparin-treated group showed a significantly (30%) shorter labor time compared to matched controls."( Does low molecular weight heparin shorten term labor?
Akerud, A; Dubicke, A; Ekman-Ordeberg, G; Hellgren, M; Malmström, A, 2010
)
0.84
"One dalteparin-treated patient had a PE confirmed by V/Q scan; another had progressive thrombosis with swelling in the affected limb."( A multicentre comparison of once-daily subcutaneous dalteparin (low molecular weight heparin) and continuous intravenous heparin in the treatment of deep vein thrombosis.
Grankvist, S; Hallert, C; Jauro, I; Ketola, K; Kim, HC; Kiviniemi, H; Koskivirta, H; Luomanmäki, K; Sörskog, L; Vilkko, P, 1996
)
1.03
"Dalteparin treatment significantly reduces LV thrombus formation in acute anterior MI but is associated with increased hemorrhagic risk."( Randomized trial of low molecular weight heparin (dalteparin) in prevention of left ventricular thrombus formation and arterial embolism after acute anterior myocardial infarction: the Fragmin in Acute Myocardial Infarction (FRAMI) Study.
Abildgaard, U; Dale, J; Kontny, F; Pedersen, TR, 1997
)
1.99
"Dalteparin-treated patients received a commencement bolus of 20 units/kg and a maintenance infusion at 10 units/kg/hr."( A controlled trial of low-molecular-weight heparin (dalteparin) versus unfractionated heparin as anticoagulant during continuous venovenous hemodialysis with filtration.
Cumming, AR; Gallagher, L; O'Brien, JL; Reeves, JH; Santamaria, JD, 1999
)
1.28
"Dalteparin and warfarin treatment was started, and symptoms relieved rapidly."( Superior mesenteric and portal vein thrombosis following laparoscopic nissen fundoplication.
Kemppainen, E; Kiviluoto, T; Kokkola, A; Sirén, J, 2000
)
1.03
"Treatment with dalteparin or dabigatran was associated with a decreased 90-day risk of VTE following primary TKA surgery compared with treatment with rivaroxaban. "( Thromboembolic and bleeding complications following primary total knee arthroplasty : a Danish nationwide cohort study.
Gromov, K; Jensen, TB; Jimenez-Solem, E; Olesen, JB; Overgaard, S; Petersen, J; Schelde, AB, 2021
)
0.97
"Treatment with dalteparin was started."( Life-threatening hemorrhage after dalteparin therapy in a patient with impaired renal function.
Drewe, J; Egger, SS; Krähenbühl, S; Sawatzki, MG, 2005
)
0.95
"Treatment with dalteparin sodium significantly reduced incidences of death and/or myocardial infarction (MI) during the first months of treatment (the reduction in the relative risk of double endpoint events was statistically significant at 47.0% at 1 month, and remained so at 2 months, but was no longer statistically significant at the 3-month assessment)."( Long-term management--the way forward?
Wallentin, L, 2000
)
0.65
"Treatment with dalteparin reduced the risk of death and myocardial infarction in high-risk (i.e."( Low-molecular-weight heparin as a bridge to timely revascularization in unstable coronary artery disease -- an update of the Fragmin during Instability in Coronary Artery Disease II Trial.
Wallentin, L, 2000
)
0.65

Toxicity

dalteparin is associated with a low risk of major side effects and is as safe as the combination of abciximab and UFH. The results of this study, detailed herein, demonstrate that long-term daltaparin is highly effective and safe.

ExcerptReferenceRelevance
" This study showed that Enoxaparin administered postoperatively 30 mg every 12 hours is more effective and as safe as unfractionated heparin prophylaxis to prevent deep venous thrombosis in patients having elective total knee arthroplasty."( Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep venous thrombosis after elective knee arthroplasty. Enoxaparin Clinical Trial Group.
Colwell, CW; Gardiner, GA; Ritter, MA; Spiro, TE; Stephens, JW; Trowbridge, AA, 1995
)
0.29
" Excessive bleeding, on the basis of specified criteria, severe adverse effects, or occurrence of clinically detected venous thromboembolism was classified as failure."( Safety of enoxaparin and dextran-70 in the prevention of venous thromboembolism in digestive surgery. A play-the-winner-designed study.
Andersen, OK; Larsen, S; Lund, H; Løvig, T; Mowinckel, P; Reiertsen, O; Størkson, R; Trondsen, E, 1993
)
0.29
" In these clinical studies, Enoxaparin, 30 mg twice daily, was shown to be as effective and safe as low dose unfractionated heparin to prevent deep venous thrombosis after hip arthroplasty."( Efficacy and safety of enoxaparin to prevent deep vein thrombosis after hip arthroplasty.
Colwell, CW; Spiro, TE, 1995
)
0.29
"Preoperative administration of enoxaparin is safe in head and neck cancer surgery, but further studies are required to evaluate its efficacy in preventing thromboembolism."( Safety of preoperative enoxaparin in head and neck cancer surgery.
al-Rawi, S; Angelard, B; Clergue, F; Dominici, L; Dubos, S; Gondret, R; Huet, Y; Saint-Guily, JL,
)
0.13
"To determine the most effective and safe dose of enoxaparin to prevent deep venous thrombosis in high-risk surgical patients."( Efficacy and safety of enoxaparin to prevent deep venous thrombosis after hip replacement surgery. Enoxaparin Clinical Trial Group.
Blasier, RB; Christie, MJ; Johnson, GJ; Lyons, RM; MacFarlane, DE; Spiro, TE; Tremaine, MD, 1994
)
0.29
"In a multicentre, randomized, double-blind controlled trial comparing the low-molecular-weight heparin enoxaparin (40 mg) with a standard unfractionated heparin (Ca-heparin, 3 x 5,000 U) in deep-vein thrombosis prophylaxis in a high-risk group of 959 hospitalized medical patients, enoxaparin was at least as efficacious as standard heparin, with fewer adverse events."( The venous thrombotic risk in non-surgical patients: epidemiological data and efficacy/safety profile of a low-molecular-weight heparin (enoxaparin). The Prime Study Group.
Flosbach, CW; Lechler, E; Schramm, W, 1996
)
0.29
" Safety outcomes were defined as the occurrence of major and minor haemorrhage, other adverse events and changes in laboratory parameters."( Efficacy and safety of postdischarge administration of enoxaparin in the prevention of deep venous thrombosis after total hip replacement. A prospective randomised double-blind placebo-controlled trial.
Bellaud, M; Compan, D; Darmon, JY; Fagola, M; Huet, Y; Planes, A; Saliba, E; Vochelle, N; Weisslinger, N, 1996
)
0.29
"Enoxaparin, 40 mg once daily, is as safe and effective as unfractionated heparin three times daily in preventing venous thromboembolism in patients undergoing major elective surgery for abdominal or pelvic malignancy."( Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery: a double-blind randomized multicentre trial with venographic assessment. ENOXACAN Study Group.
, 1997
)
0.3
"007); other adverse effects did not occur during the administration of LMWH."( [Evaluation of undesirable effects of low-molecular-weight heparin during prevention of thromboembolic disease in abdominal surgery patients].
Blanco-Benavides, R; Meillón-García, LA; Morales-Polanco, MR; Romero-Hernández, T; Sigler-Morales, L,
)
0.13
" Bleeding complications and other adverse events were registered throughout the study period."( Efficacy and safety of prolonged thromboprophylaxis with a low molecular weight heparin (dalteparin) after total hip arthroplasty--the Danish Prolonged Prophylaxis (DaPP) Study.
Andersen, G; Anderson, BS; Appelquist, E; Borris, LC; Christensen, F; Erin-Madsen, J; Hansen, BR; Hvidt, P; Hørlyck, E; Jensen, BV; Jensen, HP; Jensen, NK; Jørgensen, PS; Lassen, MR; Møller, JC; Nielsen, AB; Nielsen, JB; Paaske, B; Petersen, AO; Rotwitt, L; Siem, P; Skejø Bro, HP; Thomsen, PB; Tjalve, E; Tørholm, C, 1998
)
0.52
"We studied the outcome of 41 pregnancies in an attempt to identify an appropriate and safe anticoagulant regimen for pregnant women with cardiac valve prosthesis."( Is there a safe anticoagulation protocol for pregnant women with prosthetic valves?
Alam, SE; Arnaout, MS; Karam, K; Kazma, H; Khalil, A; Nasrallah, A; Shasha, N, 1998
)
0.3
" Adverse cardiovascular events in the 14 days after stent placement occurred in 11 patients (1."( Safety and efficacy of ticlopidine for only 2 weeks after successful intracoronary stent placement.
Bell, MR; Berger, PB; Grill, DE; Hasdai, D; Holmes, DR; Melby, S, 1999
)
0.3
"In patients receiving intracoronary stents, the discontinuation of ticlopidine therapy 14 days after stent placement is associated with a very low frequency of stent thrombosis and other adverse events."( Safety and efficacy of ticlopidine for only 2 weeks after successful intracoronary stent placement.
Bell, MR; Berger, PB; Grill, DE; Hasdai, D; Holmes, DR; Melby, S, 1999
)
0.3
" The results of this study, detailed herein, demonstrate that long-term dalteparin is highly effective and safe when used as long-term therapy for secondary prevention in selected prothrombotic disorders."( Long-term outpatient dalteparin (fragmin) therapy for arterial and venous thrombosis: efficacy and safety--a preliminary report.
Bick, RL; Rice, J, 1999
)
0.85
" Fewer total adverse events were noted in the LMWH group than in the IVUH cohort (3 versus 20; P:=0."( Safety and cost of low-molecular-weight heparin as bridging anticoagulant therapy in subacute cerebral ischemia.
Gandhi, R; Kalafut, MA; Kidwell, CS; Saver, JL, 2000
)
0.31
"Both regimens were equally safe and the risk of clinically evident DVT and PE was similar."( Efficacy and safety of weight-adapted nadroparin calcium vs. heparin sodium in prevention of clinically evident thromboembolic complications in 1,190 general surgical patients.
Büchler, MW; Egger, B; Naef, M; Schmid, SW; Wildi, S, 2000
)
0.31
" A causal relationship between unfractionated heparin and asymptomatic, transient increases in hepatic transaminase levels has been documented; these increased levels also appear to be an underrecognized, adverse effect of LMWH therapy."( Elevation of hepatic transaminases after enoxaparin use: case report and review of unfractionated and low-molecular-weight heparin-induced hepatotoxicity.
Carlson, MK; Gleason, PP; Sen, S, 2001
)
0.31
" There was no difference in the frequency or severity of adverse events."( A randomized trial to compare the efficacy, safety, cost and platelet aggregation effects of enoxaparin and unfractionated heparin (the ESCAPEU trial).
Bhargava, VK; Grover, A; Malhotra, S; Pandhi, P; Sharma, YP, 2001
)
0.31
"Thromboprophylaxis with 60 mg enoxaparin daily, in split doses, starting before surgery, is safe and appropriate in patients with hip fractures."( Thromboprophylaxis with 60 mg enoxaparin is safe in hip trauma surgery.
Greiner, N; Korninger, C; Roller, RE; Sim, E; Thaler, HW, 2001
)
0.31
"Incidence, seriousness and causality of maternal, fetal and neonatal adverse events, pregnancy outcome, and incidence of venous thromboembolism."( Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies.
Borel-Derlon, A; Borg, JY; Boudignat, O; Cohen, C; Conard, J; Darmon, JY; Francoual, C; Lepercq, J; Priollet, P; Schved, JF; Tournaire, M; Yvelin, N, 2001
)
0.31
" None of the fetal or neonatal adverse events was related to enoxaparin."( Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies.
Borel-Derlon, A; Borg, JY; Boudignat, O; Cohen, C; Conard, J; Darmon, JY; Francoual, C; Lepercq, J; Priollet, P; Schved, JF; Tournaire, M; Yvelin, N, 2001
)
0.31
"The incidence of adverse events reported could be explained by the high risk profile of the study population."( Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies.
Borel-Derlon, A; Borg, JY; Boudignat, O; Cohen, C; Conard, J; Darmon, JY; Francoual, C; Lepercq, J; Priollet, P; Schved, JF; Tournaire, M; Yvelin, N, 2001
)
0.31
"Home treatment of DVT is possible and effective, safe and cost-effective."( Could deep vein thrombosis be safely treated at home?
Cambal, M; Labas, P; Ohradka, B, 2001
)
0.31
"Bemiparin seems to be as effective and safe as the other low-molecular-weight heparins in the prevention of thromboembolic complications in orthopaedic surgery."( Effectiveness and safety of bemiparin versus low-molecular weight heparins in orthopaedic surgery.
Ferriols-Lisart, F; Ferriols-Lisart, R; Jiménez-Torres, V, 2002
)
0.31
" Herein, we studied the microhemodynamic and cellular mechanisms of this adverse effect of heparin on AT actions by the use of intravital microscopy and granulocyte culturing."( Adverse effect of heparin on antithrombin action during endotoxemia: microhemodynamic and cellular mechanisms.
Dunzendorfer, S; Hoffmann, JN; Inthorn, D; Kaneider, NC; Laschke, MW; Menger, MD; Römisch, J; Schildberg, FW; Vollmar, B; Wiedermann, CJ, 2002
)
0.31
" dalteparin is associated with a low risk of major side effects and is as safe as the combination of abciximab and UFH."( Safety and efficacy of abciximab combined with dalteparin in treatment of acute coronary syndromes.
Armstrong, P; Califf, R; Husted, S; James, S; Kontny, F; Niemminen, M; Pfisterer, M; Simoons, ML; Wallentin, L, 2002
)
1.48
"Lovenox (enoxaparin sodium) therapy appears to be safe and efficacious for pregnant women who are candidates for either prophylactic or therapeutic heparin."( ACOG Committee Opinion: safety of Lovenox in pregnancy.
, 2002
)
0.31
" In conclusion, the use of intravenous enoxaparin in conjunction with intravenous eptifibatide during nonemergent coronary and peripheral vascular intervention is safe and effective and eliminates the need for routine measurement of ACT during the procedure."( Safety and efficacy of combined use of low molecular weight heparin (enoxaparin, lovenox) and glycoprotein IIb/IIIa receptor antagonist (eptifibatide, integrelin) during nonemergent coronary and peripheral vascular intervention.
Ahmed, A; Elbazour, M; Guerrero, M; Khosla, S; Kunjummen, B; Lubell, D; Manda, R; Razminia, M; Trivedi, A; Vidyarthi, V,
)
0.13
"Lovenox (enoxaparin sodium) therapy appears to be safe and efficacious for pregnant women who are candidates for either prophylactic or therapeutic heparin."( ACOG committee opinion. Safety of Lovenox in pregnancy. Number 276, October 2002. Committee on Obstetric Practice.
, 2002
)
0.31
"The use of intravenous enoxaparin, a glyco-protein (GP) IIb/IIIa inhibitor, during percutaneous coronary intervention (PCI) has been shown to be safe and to possibly reduce in-hospital and 30-day major adverse cardiac events(MACE)."( Safety and efficacy of low-dose intravenous enoxaparin and GP IIb/IIIa inhibitor therapy during PCI.
Borkowski, R; Carnendran, L; Markabawi, B; Warner, MF, 2003
)
0.32
"Subcutaneous Enoxaparin given at least for 48 hours before PCI with out additional UFH or LMWH during or after PCI was both safe and effective in high risk UA/NQMI patients."( [The safety and efficacy of pre-treatment with enoxaparin (Clexane) in acute coronary syndrome patients undergoing percutaneous coronary intervention].
Chen, BX; Hu, DY; Jia, SQ; Kong, FL; Li, TC; Wang, L; Zhao, H; Zhao, XL, 2003
)
0.32
" This trial shows that bemiparin started postoperatively is as effective and safe as enoxaparin started preoperatively in the prevention of venous thromboembolism in patients undergoing total knee replacement."( Efficacy and safety of bemiparin compared with enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind clinical trial.
Castellet, E; Navarro-Quilis, A; Paz-Jiménez, J; Planès, A; Rocha, E, 2003
)
0.32
" It is not clear if combining enoxaparin with glycoprotein IIb/IIIa inhibitors is as safe or as effective as the current standard combination of unfractionated heparin with glycoprotein IIb/IIIa inhibitors."( Safety and efficacy of enoxaparin vs unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes who receive tirofiban and aspirin: a randomized controlled trial.
Ardissino, D; Bilheimer, DW; Blazing, MA; Braunwald, E; Califf, RM; de Lemos, JA; DiBattiste, PM; Fox, KA; Gardner, LH; Hasselblad, V; Lewis, EF; Palmisano, J; Pfeffer, MA; Ramsey, KE; Snapinn, SM; Verheugt, FW; White, HD, 2004
)
0.32
"Enoxaparin seems to offer safe and effective procedural anticoagulation in patients undergoing percutaneous intervention for acute coronary syndromes."( Can enoxaparin safely replace unfractionated heparin during coronary intervention in acute coronary syndromes?
Ayzenberg, Y; Cafri, C; Gilutz, H; Ilia, R; Wolak, A; Zahger, D, 2004
)
0.32
"3% of patients no adverse event was reported."( Safety and efficacy of single bolus anticoagulation with enoxaparin for chronic hemodialysis. Results of an open-label post-certification study.
Eckert, M; Hafner, G; Hohmann, V; Klingel, R; Lotz, J; Schwarting, A, 2004
)
0.32
"Single bolus anticoagulation with enoxaparin was safe and effective for chronic HD."( Safety and efficacy of single bolus anticoagulation with enoxaparin for chronic hemodialysis. Results of an open-label post-certification study.
Eckert, M; Hafner, G; Hohmann, V; Klingel, R; Lotz, J; Schwarting, A, 2004
)
0.32
" The primary efficacy endpoint was recurrent DVT (confirmed by venography or ultrasonography), and safety endpoints included bleeding and serious adverse events."( An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis.
Araújo, GR; Dietrich-Neto, F; Karaoglan de Moura, L; Lastoria, S; Maffei, FH; Michaelis, W; Ramacciotti, E; Sandri, JL, 2004
)
0.32
"5 mg/kg subcutaneous is at least as effective and safe as conventional treatment with a continuous intravenous infusion of UFH."( An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis.
Araújo, GR; Dietrich-Neto, F; Karaoglan de Moura, L; Lastoria, S; Maffei, FH; Michaelis, W; Ramacciotti, E; Sandri, JL, 2004
)
0.32
"Enoxaparin proved to be efficacious and safe in the management of deep venous thrombosis with or without pulmonary embolism in patients affected by acute leukemia."( Safety and efficacy of enoxaparin treatment in venous thromboembolic disease during acute leukemia.
Anselmi, E; Arcari, AL; Bernuzzi, P; Bertè, R; Cavanna, L; Imberti, D; Lazzaro, A; Moroni, CF; Vallisa, D,
)
0.13
"Our findings suggest that a fixed low dose of dalteparin sodium of 5000 U/d is effective and safe in preventing VTE in obese and elderly hospitalized medical patients."( Efficacy and safety of fixed low-dose dalteparin in preventing venous thromboembolism among obese or elderly hospitalized patients: a subgroup analysis of the PREVENT trial.
Cohen, AT; Goldhaber, SZ; Kucher, N; Leizorovicz, A; Olsson, CG; Turpie, AG; Vaitkus, PT, 2005
)
0.86
" The results of this study indicate that nadroparin alone is useful and safe in the management of pregnant patients with APS."( Efficacy and safety of nadroparin in the treatment of pregnant women with antiphospholipid syndrome: a prospective cohort study.
Chiarelli, S; De Silvestro, G; Fais, G; Favaro, M; Pengo, V; Ruffatti, A; Suma, V; Todesco, S; Tonello, M, 2005
)
0.33
"Discontinuing LMWH more than 12 hours before delivery is safe in relation to maternal hemorrhagic complications."( The safety of low molecular weight heparin therapy during labor.
Kupferminc, MJ; Landsberg, JA; Lessing, JB; Many, A; Maslovitz, S; Varon, D, 2005
)
0.33
"Prospective, randomized, double-blind study (POLENOX) proved that administration of low molecular weight heparin (LMWH)--enoxaparin for elective percutaneous coronary interventions (PCI) is as safe and as effective like unfractionated heparin (UFH)."( [Safety and efficacy of dalteparin administration for elective percutaneous interventions in patients pre-treated with aspirin and ticlopidine].
Bartuś, S; Chyrchel, M; Dubiel, JS; Dudek, D; Legutko, J; Rzeszutko, L, 2004
)
0.63
" Adverse drug reactions (ADR) were recorded."( Administration of enoxaparin by continuous infusion in a naturalistic setting: analysis of renal function and safety.
Bies, RR; Bobek, MB; Dasta, JF; Feng, Y; Kane-Gill, SL; Pruchnicki, MC, 2005
)
0.33
" All patients were monitored for adverse clinical events (i."( [Comparison of the antithrombotlic effect and safety between intravenous nadroparin and unfractionated heparin in patients undergoing percutaneous coronary intervention].
Chen, JZ; Fu, GS; Huang, WJ; Qiu, YG; Shen, FR; Tao, QM; Wang, JA; Zhang, FR; Zhao, LL; Zheng, LR; Zhu, JH, 2005
)
0.33
" The associations of adverse events with potential risk factors, indication for dalteparin therapy, and prescribing clinic were analyzed."( Safety of outpatient dalteparin therapy in veterans with mechanical heart valves.
Copeland, LA; Flanagan, PS; O'Neill, JL; Zaleon, CR, 2005
)
0.87
"In high risk critically ill patients citrate based anticoagulation for CVVH is safe in terms of bleeding complications and transfusion requirements."( Safety of citrate based hemofiltration in critically ill patients at high risk for bleeding: a comparison with nadroparin.
Boerma, EC; Kingma, WP; Postma, SR; Van der Voort, PH; Van Roon, EN, 2006
)
0.33
" Adverse events were similar in the three groups."( A randomized controlled clinical trial to evaluate the efficacy, safety, cost-effectiveness and effect on PAI-1 levels of the three low-molecular-weight heparins--enoxaparin, nadroparin and dalteparin. The ESCAPe-END study.
Bhalla, A; Grover, A; Malhotra, S; Pandhi, P; Shafiq, N; Sharma, N, 2006
)
0.52
"Bemiparin has shown to be effective and safe in clinical trials in total knee or hip replacement."( A prospective observational study on the effectiveness and safety of bemiparin, first dose administered 6 h after knee or hip replacement surgery.
Abad, JI; Gómez-Outes, A; Martínez-González, J; Rocha, E, 2007
)
0.34
" We analysed rates of documented symptomatic venous thromboembolism (VTE) [deep-vein thrombosis (DVT) and pulmonary embolism (PE)] confirmed by objective methods, major bleeding, death, thrombocytopaenia and other adverse events up to 6 weeks."( A prospective observational study on the effectiveness and safety of bemiparin, first dose administered 6 h after knee or hip replacement surgery.
Abad, JI; Gómez-Outes, A; Martínez-González, J; Rocha, E, 2007
)
0.34
"Bemiparin prophylaxis, started 6 h after surgery and given for 5-6 weeks after total hip or knee replacement, was associated with low rates of VTE, major bleeding and other adverse events in normal clinical practice."( A prospective observational study on the effectiveness and safety of bemiparin, first dose administered 6 h after knee or hip replacement surgery.
Abad, JI; Gómez-Outes, A; Martínez-González, J; Rocha, E, 2007
)
0.34
"We compared the rates of major adverse cardiovascular events (MACE) as well as the rates of bleeding in medically managed patients randomized to ENOX versus UFH in the ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction 25) trial, stratified by concomitant clopidogrel use."( Efficacy and safety of enoxaparin versus unfractionated heparin in patients with ST-segment elevation myocardial infarction also treated with clopidogrel.
Antman, EM; Braunwald, E; Dalby, A; Duris, T; Gao, R; Lopez-Sendon, J; Morrow, DA; Murphy, SA; Pfisterer, M; Sabatine, MS, 2007
)
0.34
" They analyzed rates of documented symptomatic venous thromboembolism (VTE) (deep vein thrombosis and pulmonary embolism) confirmed by objective methods, major bleeding, death, thrombocytopenia, and other adverse events."( Evaluation of the effectiveness and safety of bemiparin in a large population of orthopedic patients in a normal clinical practice.
Fontcuberta, J; Gómez-Outes, A; Martínez-González, J; Otero-Fernández, R; Rocha, E, 2008
)
0.35
" One major adverse clinical event (0."( Effectiveness and safety of reduced-dose enoxaparin in non-ST-segment elevation acute coronary syndrome followed by antiplatelet therapy alone for percutaneous coronary intervention.
Davis, KE; Denardo, SJ; Tcheng, JE, 2007
)
0.34
" Previous evidence has shown that these drugs are safe and effective in this indication."( AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation.
Adams, J; Appel, KF; Eggers, E; Haake, H; Harenberg, J; Heuer, H; Oeckinghaus, R; Seidel, K; Tebbe, U, 2008
)
0.35
"Certoparin administered at 8000 U anti-Xa twice daily independent of body weight was safe and appeared to be effective in patients with non-valvular AF undergoing electrical cardioversion."( AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation.
Adams, J; Appel, KF; Eggers, E; Haake, H; Harenberg, J; Heuer, H; Oeckinghaus, R; Seidel, K; Tebbe, U, 2008
)
0.35
" However total rate of all adverse events after PCI turned out to be minimal (7."( [Efficacy and safety of enoxaparin use during drug-eluting stents implantation].
Batyraliev, TA; Dolgikh, NN; Kadyrov, BK; Lazarev, IA; Mustafaoglu, F; Pershukov, IV; Petrakova, LN; Pia, IuV; Ramazanov, DM; Sal'nikov, DV; Shul'zhenko, LV; Sidorenko, BA, 2008
)
0.35
" No adverse maternal-fetal side effects were reported on enoxaparin alone or enoxaparin-metformin."( Enoxaparin-metformin and enoxaparin alone may safely reduce pregnancy loss.
Glueck, CJ; Goldenberg, N; Khan, N; Ramidi, G; Wang, P, 2009
)
0.35
" Furthermore, there is no difference according to liver enzymes elevation and cardio-vascular adverse events."( [Rivaroxaban (Xarelto): efficacy and safety].
Arnaout, L; Bellamy, L; Chabbouh, T; Rosencher, N, 2008
)
0.35
" Therefore, we believe that intravenous enoxaparin is a safe alternative to unfractionated heparin in both settings."( Safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention.
Cheong, BY; Díez, JG; Ferguson, JJ; Medina, HM; O'Meallie, L, 2009
)
0.35
" To confront these challenges, cardiologists committed to the continued use of LMWH must develop safe and user-friendly approaches to transition patients from the noninvasive to invasive settings."( Avoiding intelligence failures in the cardiac catheterization laboratory: Strategies for the safe and rational use of dalteparin or enoxaparin during percutaneous coronary intervention.
Bullock-Palmer, RP; Cavusoglu, E; Marmur, JD; Poludasu, S, 2009
)
0.56
"Nadroparin is both safe and effective for the treatment of DVT during pregnancy and puerperium."( Efficacy and safety of nadroparin and unfractionated heparin for the treatment of venous thromboembolism during pregnancy and puerperium.
Antonijević, N; Djordjević, V; Ilić, V; Kovac, M; Lazić, R; Mitić, G; Novakov-Mikić, A; Povazan, L; Salatić, I, 2010
)
0.36
"2 U/mL, is safe for women with mechanical prosthetic heart valves (MPHV)."( A prospective trial showing the safety of adjusted-dose enoxaparin for thromboprophylaxis of pregnant women with mechanical prosthetic heart valves.
Aziz, RH; Dominique, TG; Jacobson, BF; Pravin, M; Saeed, CR; Serasheini, M, 2011
)
0.37
" Safety end points included minor and major bleeding as well as serious adverse events."( Long-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep vein thrombosis in the TROMBOTEK trial.
Akcalı, Y; Filizcan, U; Hasan, E; Karabay, O; Koksoy, C; Kurtoglu, M, 2010
)
0.36
"9%) adverse events documented were serious adverse events, but none of the serious adverse events leading to death were related to the study medications."( Long-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep vein thrombosis in the TROMBOTEK trial.
Akcalı, Y; Filizcan, U; Hasan, E; Karabay, O; Koksoy, C; Kurtoglu, M, 2010
)
0.36
"In patients receiving oral anticoagulant therapy with a target INR of 2,0-3,0 and at an intermediate risk of thromboembolic events who require interruption of oral anticoagulant therapy a half therapeutic dose of enoxaparin seems to be safe and effective for bridging."( Bridging with enoxaparin using a half-therapeutic dose regimen: safety and efficacy.
Essers, E; Gottstein, S; Klamroth, R; Landgraf, H, 2010
)
0.36
" The rates of in-hospital major adverse cardiac or cerebral events were 11."( Safety and effectiveness of enoxaparin following fibrinolytic therapy: Results of the Acute Myocardial Infarction (AMI)-QUEBEC registry.
Afilalo, M; Dery, JP; Eisenberg, MJ; El-Rayes, M; Harvey, R; Huynh, T; Kouz, R; Kouz, S; Lauzon, C; Mansour, S; Nguyen, M; Rinfret, S; Schampaert, E; Tardif, JC; Van Kieu, AM, 2010
)
0.36
"There was no significant difference in the rates of in-hospital adverse events in the ENOX group compared with the UFH group, when used in the real-life context."( Safety and effectiveness of enoxaparin following fibrinolytic therapy: Results of the Acute Myocardial Infarction (AMI)-QUEBEC registry.
Afilalo, M; Dery, JP; Eisenberg, MJ; El-Rayes, M; Harvey, R; Huynh, T; Kouz, R; Kouz, S; Lauzon, C; Mansour, S; Nguyen, M; Rinfret, S; Schampaert, E; Tardif, JC; Van Kieu, AM, 2010
)
0.36
"In acutely ill medical patients of at least 40 years of age, thromboprophylaxis with certoparin 3000 IU daily is effective and safe in comparison with 7500 IU twice daily UFH."( An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely ill medical patients: CERTAIN.
Abletshauser, C; Bramlage, P; Greinacher, A; Haas, S; Riess, H; Schellong, SM; Schwanebeck, U; Sieder, C, 2010
)
0.36
" The aim of this prospective study was to determine the lowest single bolus dose of low-molecular-weight heparin nadroparin for safe and effective HD in patients with a bleeding risk."( The individually optimized bolus dose of nadroparin is safe and effective in diabetic and nondiabetic patients with bleeding risk on hemodialysis.
Jelicic, I; Kovacic, V; Ljutic, D; Radic, J; Sain, M, 2011
)
0.37
" The goal of this study was to determine whether enoxaparin for early venous thromboembolism (VTE) prophylaxis is safe for hemodynamically stable patients with TBIs."( Is early venous thromboembolism prophylaxis safe in trauma patients with intracranial hemorrhage.
Davidson, MA; Guillamondegui, O; Koehler, DM; Shipman, J, 2011
)
0.37
" Neither major adverse events nor major hemorrhages were reported Prolonged activated partial thromboplastin times (aPTT) at 30 minutes after hemodialysis were reported in two cases."( Efficacy and safety of enoxaparin during hemodialysis: results from the HENOX study.
Bannachak, D; Chittinandana, A; Kanjanakul, I; Krairittichai, U; Sumethkul, V; Thitiarchakul, S; Vareesangthip, K, 2011
)
0.37
" IRIS aimed to assess whether LMWH is at least as safe as UFH in this population."( Safety profile of tinzaparin versus subcutaneous unfractionated heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis: the Innohep® in Renal Insufficiency Study (IRIS).
Clonier, F; Janas, M; Leizorovicz, A; Maddalena, M; Mottier, D; Siguret, V; Stinson, J; Townshend, G, 2011
)
0.37
"04) were the only significant independent predictors for any major adverse event."( Safety of coronary artery bypass surgery during therapeutic oral anticoagulation.
Airaksinen, KE; Biancari, F; Karjalainen, P; Kuttila, K; Laitio, T; Lip, GY; Mikkola, R; Porela, P, 2011
)
0.37
"Our study suggests that CABG is a safe procedure during TOAC with no excess bleeding or major complications."( Safety of coronary artery bypass surgery during therapeutic oral anticoagulation.
Airaksinen, KE; Biancari, F; Karjalainen, P; Kuttila, K; Laitio, T; Lip, GY; Mikkola, R; Porela, P, 2011
)
0.37
" For those records documenting tinzaparin use and pregnancy outcome, information was extracted into a standardised case report form; these were reviewed for adverse events, which were submitted for adjudication by independent experts in obstetric medicine and haematology."( Tinzaparin use in pregnancy: an international, retrospective study of the safety and efficacy profile.
Borg, JY; Greer, IA; Nelson-Piercy, C; Powrie, R; Rodger, M; Stinson, J; Talbot, DJ, 2011
)
0.37
" Most of the bleeding and adverse events were subcutaneous minor bleeding."( Clinical safety and anticoagulation efficacy of low-molecular-weight heparins in chronic hemodialysis patients: a single medical center experience.
Chang, HW; Chen, TC; Chuang, FR; Chuang, PH; Lee, CH; Ng, HY; Su, YJ; Wang, IK; Wu, CH; Yang, CC, 2011
)
0.37
" Tolerability was good, with only mild and reversible adverse events during the treatment."( Switching from enoxaparin to dabigatran etexilate: pharmacokinetics, pharmacodynamics, and safety profile.
Clemens, A; Feuring, M; Härtter, S; Sennewald, R; Stangier, J; van Ryn, J; Yamamura, N, 2012
)
0.38
"To examine whether it is safe to continue low-dose (100 mg/day) aspirin perioperatively as a part of standard multimodal venous thromboembolic prophylaxis for total hip arthroplasty (THA) or total knee arthroplasty (TKA)."( Safety of peri-operative low-dose aspirin as a part of multimodal venous thromboembolic prophylaxis for total knee and hip arthroplasty.
Cossetto, DJ; Goudar, A; Parkinson, K, 2012
)
0.38
"It is safe to continue low-dose (100 mg/day) aspirin in the perioperative period as a part of multimodal prophylaxis against deep vein thrombosis."( Safety of peri-operative low-dose aspirin as a part of multimodal venous thromboembolic prophylaxis for total knee and hip arthroplasty.
Cossetto, DJ; Goudar, A; Parkinson, K, 2012
)
0.38
" In conclusion, compared with immediate PCI, d-PCI after ATT in selected, stabilized patients with ACS and a large intracoronary thrombus and without an urgent need for revascularization is probably safe and associated with a reduction in thrombotic burden, angiographic complications, and the need of revascularization."( Safety and efficacy of intense antithrombotic treatment and percutaneous coronary intervention deferral in patients with large intracoronary thrombus.
Alfonso, F; Bañuelos, C; Echavarría-Pinto, M; Escaned, J; Fernández, C; Fernandez-Ortiz, A; García, E; Gonzalo, N; Gorgadze, T; Hernández, R; Ibañez, B; Jiménez-Quevedo, P; Lopes, R; Macaya, C; Nuñez-Gil, IJ, 2013
)
0.39
" The outcome measurements were the incidence of total VTE, deep venous thrombosis (DVT), symptomatic VTE, pulmonary embolism (PE), major bleeding and any other adverse event."( [Efficacy and safety of fondaparinux versus enoxaparin for preventing venous thromboembolism after major orthopedic surgery: a meta-analysis].
Li, H; Shi, Z; Wang, J; Xiao, J, 2013
)
0.39
" However, both drugs had some adverse effects."( Safety of fondaparinux versus enoxaparin after TKA in Japanese patients.
Hosaka, K; Ishii, T; Ryu, K; Saito, S; Sumino, T; Suzuki, G; Suzuki, T; Tokuhashi, Y, 2013
)
0.39
"We conclude that low-molecular-weight heparin either in a low-dose or high-dose regime during a peripheral EVR is safe concerning bleeding complications and acute reobstructions."( Safety and efficacy of periprocedural anticoagulation with enoxaparin in patients undergoing peripheral endovascular revascularization.
Brodmann, M; Deutschmann, H; Dorr, A; Froehlich, H; Gary, T; Hafner, F; Kvas, E; Pilger, E, 2014
)
0.4
" The authors hypothesize that early chemoprophylaxis in patients with TBI is safe and efficacious."( Safety and efficacy of early thromboembolism chemoprophylaxis after intracranial hemorrhage from traumatic brain injury.
Barnes, SL; Farooqui, A; Hiser, B; Litofsky, NS, 2013
)
0.39
"Use of chemoprophylaxis in TBI 24 hours after stable head CT is safe and decreases the rate of DVT formation."( Safety and efficacy of early thromboembolism chemoprophylaxis after intracranial hemorrhage from traumatic brain injury.
Barnes, SL; Farooqui, A; Hiser, B; Litofsky, NS, 2013
)
0.39
"001) reflecting the toxic effect of DXR on EC."( Doxorubicin-induced vascular toxicity--targeting potential pathways may reduce procoagulant activity.
Bar Joseph, H; Ben Aharon, I; Farzam, N; Levi, M; Savion, N; Shalgi, R; Shenkman, B; Stemmer, SM; Tzabari, M, 2013
)
0.39
"With patients in whom it is indicated, the home therapy ankle pathway has proved to be a safe and resource sparing method of managing ankle fractures prior to surgery."( Home therapy pathway - safe and streamlined method of initial management of ankle fractures.
Baraza, N; Dhukaram, V; Lever, S, 2013
)
0.39
"Obesity increases the risk for venous thromboembolism (VTE), but whether high-dose thromboprophylaxis is safe and effective in morbidly obese inpatients is unknown."( Efficacy and safety of high-dose thromboprophylaxis in morbidly obese inpatients.
Deal, EN; Gage, BF; Milligan, PE; Thoelke, MS; Wang, TF; Wong, CA, 2014
)
0.4
" Additional adverse events were recorded throughout the study."( Safety and efficacy of edoxaban in patients undergoing hip fracture surgery.
Abe, K; Fuji, T; Fujita, S; Kawai, Y; Kimura, T; Kiuchi, Y; Nakamura, M; Tachibana, S, 2014
)
0.4
" The incidence of adverse events was 72."( Safety and efficacy of edoxaban in patients undergoing hip fracture surgery.
Abe, K; Fuji, T; Fujita, S; Kawai, Y; Kimura, T; Kiuchi, Y; Nakamura, M; Tachibana, S, 2014
)
0.4
" Recently, the use of safe-dose recombinant tissue-type plasminogen activator (rTPA) has been proposed for the treatment of moderate PE demonstrating to be safe and more effective than standard anticoagulation."( [Safe dose rTPA for massive pulmonary embolism associated with high bleeding risk: a case report and review of the literature].
Cannone, M; La Torre, PP; Mele, A; Mele, M, 2014
)
0.4
"Early enoxaparin-based anticoagulation may be a safe option in trauma patients with blunt solid organ injury."( Early thromboembolic prophylaxis in patients with blunt solid abdominal organ injuries undergoing nonoperative management: is it safe?
Friese, RS; Green, DJ; Gries, L; Harrison, C; Joseph, B; Kulvatunyou, N; Lubin, D; O'Keeffe, T; Pandit, V; Rhee, P; Tang, A; Zangbar, B, 2015
)
0.42
" The bleeding risk of dental procedures and the incidence of clinical adverse outcomes were not significantly different between the UFH group and the enoxaparin group."( Safety and cost-effectiveness of bridge therapies for invasive dental procedures in patients with mechanical heart valves.
Chang, HJ; Chung, N; Ha, JW; Hong, GR; Lee, SH; Shim, CY; Won, KB, 2014
)
0.4
" There were no related serious adverse events, no clinically relevant bleeding events, and no symptomatic recurrent VTEs."( Multicenter dose-finding and efficacy and safety outcomes in neonates and children treated with dalteparin for acute venous thromboembolism.
Burr, S; Goldenberg, NA; Hamblin, F; Kulkarni, R; O'Brien, SH; Wallace, A, 2014
)
0.62
" Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions."( Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial.
Abe, K; Fuji, T; Fujita, S; Ibusuki, K; Kawai, Y; Kimura, T; Nakamura, M; Tachibana, S; Ushida, H; Wang, CJ, 2014
)
0.4
"Outpatient implantation of implantable cardioverter-defibrillators is safe and reduces costs."( Safety of Outpatient Implantation of the Implantable Cardioverter-defibrillator.
Arenal Maíz, Á; Atienza Fernández, F; Ávila Alonso, P; Datino, T; Eidelman, G; Fernández-Avilés, F; González-Torrecilla, E; Hernández-Hernández, J; Miracle Blanco, Á; Núñez García, A, 2015
)
0.42
"Heparin and its derivatives are known to attenuate cancer metastasis in preclinical models, but have not been used clinically due to adverse bleeding effects."( Anti-metastasis efficacy and safety of non-anticoagulant heparin derivative versus low molecular weight heparin in surgical pancreatic cancer models.
Alyahya, R; Mousa, SA; Racz, M; Stain, SC; Sudha, T, 2015
)
0.42
"LMWH seems to be safe and efficacious for both management and prophylaxis of VTEs in pediatric neurosurgery."( The safety and efficacy of use of low-molecular-weight heparin in pediatric neurosurgical patients.
Briceño, V; Fridley, J; Gonda, DD; Jea, A; Lam, SK; Luerssen, TG; Ryan, SL, 2015
)
0.42
" Adverse events, based on the Common Terminology Criteria for Adverse Events, Version 4, were recorded."( Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan.
Eguchi, F; Goto, M; Miyamoto, S; Nakahara, H; Ogawa, M; Sanui, A; Satoh, S; Takashima, T; Tatsumura, M; Yoshizato, T, 2015
)
0.42
"0%) Grade 1 adverse events: elevated aspartate aminotransferase or alanine aminotransferase levels in eight patients, chest pain in one patient, and subcutaneous hematoma in one patient."( Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan.
Eguchi, F; Goto, M; Miyamoto, S; Nakahara, H; Ogawa, M; Sanui, A; Satoh, S; Takashima, T; Tatsumura, M; Yoshizato, T, 2015
)
0.42
"Whole milligram dosing of enoxaparin for thrombosis is feasible, safe and effective in premature and term neonates."( Feasibility and safety of enoxaparin whole milligram dosing in premature and term neonates.
Bhatt, MD; Chan, AK; Goldsmith, R; Paes, BA, 2015
)
0.42
" The secondary endpoints were a composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, a new target vessel revascularisation and all-cause mortality at 30 days."( Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction.
Laine, M; Nieminen, T; Tierala, I; Viikilä, J, 2016
)
0.43
"The results show that the treatment with heparin and nadroparin is safe and effective."( The safety and efficacy of Heparin and Nadroparin compared to placebo in acute ischemic stroke - pilot study.
Dluha, J; Dusenka, R; Kalmarova, K; Kantorova, E; Kurca, E; Nosal, V; Sivak, S; Turcanova Koprusakova, M, 2016
)
0.43
" The primary outcome was the incidence of symptomatic pulmonary embolism after surgery, and the secondary outcome was the incidence of bleeding as an adverse effect of enoxaparin injection."( Safety and efficacy of postoperative pharmacologic thromboprophylaxis with enoxaparin after pancreatic surgery.
Adachi, T; Eguchi, S; Fujita, F; Hidaka, M; Imamura, H; Kitasato, A; Kuroki, T; Soyama, A; Takatsuki, M; Tanaka, T, 2017
)
0.46
"The use of enoxaparin is considered to be safe and effective for pulmonary embolism prophylaxis after pancreatic surgery."( Safety and efficacy of postoperative pharmacologic thromboprophylaxis with enoxaparin after pancreatic surgery.
Adachi, T; Eguchi, S; Fujita, F; Hidaka, M; Imamura, H; Kitasato, A; Kuroki, T; Soyama, A; Takatsuki, M; Tanaka, T, 2017
)
0.46
" The usage of enoxaparin for venous thromboembolism prophylaxis is safe for Japanese patients after gastrectomy."( Safety and Effectiveness of Enoxaparin as Venous Thromboembolism Prophylaxis after Gastric Cancer Surgery in Japanese Patients.
Kusanagi, H; Yanagita, T, 2016
)
0.43
"Our study suggests that anticoagulation with IV enoxaparin infused over 30 minutes is a safe and an equally effective alternative to subcutaneous enoxaparin in critically ill infants and children."( IV Versus Subcutaneous Enoxaparin in Critically Ill Infants and Children: Comparison of Dosing, Anticoagulation Quality, Efficacy, and Safety Outcomes.
Alfares, FA; Berger, JT; Chounoune, R; Corcoran, J; Diab, YA; Endicott, KM; Ferrell, B; Nath, DS; Ramakrishnan, K; Rooney, S; Shankar, V; Zurakowski, D, 2017
)
0.46
" However, enoxaparin was found to be as safe as aspirin with respect to bleeding, and fondaparinux was as safe as aspirin for risk of wound complications."( Comparative Effectiveness and Safety of Drug Prophylaxis for Prevention of Venous Thromboembolism After Total Knee Arthroplasty.
Bini, SA; Cafri, G; Cheetham, CT; Chen, Y; Gould, MK; Khatod, M; Paxton, EW; Sluggett, J, 2017
)
0.46
" Multivariate logistic regression models were used to examine associations between first- and third-trimester exposure to enoxaparin, major malformations, and other adverse birth outcomes, adjusted for confounders."( The Fetal Safety of Enoxaparin Use During Pregnancy: A Population-Based Retrospective Cohort Study.
Daniel, S; Fishman, B; Gorodischer, R; Koren, G; Levy, A; Matok, I; Shlomo, M; Wiznitzer, A, 2017
)
0.46
" Extended anticoagulation after oncologic liver surgery is safe and effective."( Extended pharmacologic thromboprophylaxis in oncologic liver surgery is safe and effective.
Aloia, TA; Davis, CH; Day, RW; Kim, BJ; Kroll, MH; Narula, N; Tzeng, CWD, 2017
)
0.46
" Conclusions These preliminary data suggest that extended pharmacologic thromboprophylaxis for liver surgery patients is safe and effective."( Extended pharmacologic thromboprophylaxis in oncologic liver surgery is safe and effective.
Aloia, TA; Davis, CH; Day, RW; Kim, BJ; Kroll, MH; Narula, N; Tzeng, CWD, 2017
)
0.46
" In addition, the incidence of all enoxaparin treatment- and operation-related adverse events was investigated."( Prophylaxis of Postoperative Venous Thromboembolism Using Enoxaparin After Esophagectomy: A Prospective Observational Study of Effectiveness and Safety.
Baba, H; Baba, Y; Hiyoshi, Y; Imamura, Y; Ishimoto, T; Iwatsuki, M; Miyamoto, Y; Watanabe, M; Yoshida, N, 2018
)
0.48
" Regarding enoxaparin-related adverse events, four minor bleeds occurred but did not require discontinuation of enoxaparin."( Prophylaxis of Postoperative Venous Thromboembolism Using Enoxaparin After Esophagectomy: A Prospective Observational Study of Effectiveness and Safety.
Baba, H; Baba, Y; Hiyoshi, Y; Imamura, Y; Ishimoto, T; Iwatsuki, M; Miyamoto, Y; Watanabe, M; Yoshida, N, 2018
)
0.48
"The authors believe that thromboprophylaxis using enoxaparin is safe and can prevent VTE after esophagectomy."( Prophylaxis of Postoperative Venous Thromboembolism Using Enoxaparin After Esophagectomy: A Prospective Observational Study of Effectiveness and Safety.
Baba, H; Baba, Y; Hiyoshi, Y; Imamura, Y; Ishimoto, T; Iwatsuki, M; Miyamoto, Y; Watanabe, M; Yoshida, N, 2018
)
0.48
" In conclusion, this study suggests that 40 mg once daily of Ce, a biosimilar enoxaparin, is as effective and safe as the branded Sanofi enoxaparin in the prophylaxis of VTE in patients submitted to major abdominal surgery at risk for VTE."( Efficacy and Safety of a Biosimilar Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: A Randomized, Prospective, Single-Blinded, Multicenter Clinical Trial.
Afiune, JB; Agati, L; Aguiar, VCR; Araujo, GR; Assao, VT; Caffaro, RA; Caltabiano, TB; Castelli, V; Colnago, EMDS; Correa, JA; Costa, AJV; DalAcqua, LZ; Davila, R; de Lima, TAM; de Souza, DG; Ferreira, U; Fugii, EY; Magella, FM; Matheus, WE; Mussalem, JS; Neto, SG; Osvaldt, AB; Pazetto, LE; Ramacciotti, E; Raymundo, SRO; Rodrigues, DG; Russeff, GJDS; Sato, DY; Toffoletto, O; Volpiani, GG, 2018
)
0.48
"This study aimed to assess whether low-molecular-weight heparin (LMWH) is effective and safe in preventing postoperative venous thromboembolism (VTE) in patients undergoing esophageal cancer surgery."( Efficacy and Safety of Enoxaparin for Prophylaxis of Postoperative Venous Thromboembolism After Esophagectomy: A Single-center Prospective Randomized Controlled Phase II Study.
Hirata, S; Matsuhashi, N; Sakuratani, T; Shimokawa, T; Tanaka, H; Tanaka, Y; Yamada, A; Yamaguchi, K; Yoshida, K, 2019
)
0.51
" One patient required a switch to fondaparinux due to an adverse reaction."( Safety and Efficacy of Tinzaparin Anticoagulation during Nocturnal Hemodialysis.
Akbari, A; Brown, PA; Bugeja, A; Harris, S; Krepelka, T; Liberty, C; McCormick, B; St-Cyr, G, 2019
)
0.51
"Tinzaparin was safe and efficacious for most INHD patients without accumulation or bleeding."( Safety and Efficacy of Tinzaparin Anticoagulation during Nocturnal Hemodialysis.
Akbari, A; Brown, PA; Bugeja, A; Harris, S; Krepelka, T; Liberty, C; McCormick, B; St-Cyr, G, 2019
)
0.51
"We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy."( Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triag
Bansilal, S; Ben-Yehuda, O; Brener, SJ; Chen, S; Dangas, GD; Feite, F; Huang, X; Kirtane, AJ; Mehran, R; Redfors, B; Souza, CF; Stone, GW; Zhang, Y, 2020
)
0.56
" Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14."( Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triag
Bansilal, S; Ben-Yehuda, O; Brener, SJ; Chen, S; Dangas, GD; Feite, F; Huang, X; Kirtane, AJ; Mehran, R; Redfors, B; Souza, CF; Stone, GW; Zhang, Y, 2020
)
0.56
" Concomitant administration of single-dose DS-1040 with multiple-dose aspirin, multiple-dose clopidogrel, or single-dose enoxaparin, consistent with clinically relevant dose regimens, was safe and well tolerated with no serious treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, bleeding-related TEAEs, and no significant changes in coagulation parameters."( Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin.
Dishy, V; Kobayashi, F; Kochan, J; Limsakun, T; McPhillips, P; Mendell, J; Orihashi, Y; Pav, J; Pizzagalli, F; Rambaran, C; Vandell, AG; Warren, V; Zhou, J, 2020
)
0.56
" Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction."( Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.
Babayan, LM; Behbakht, K; Breed, CA; Brennecke, A; Cheng, G; Corr, BR; Flink, D; Guntupalli, SR; Lefkowits, C; Matsuo, K; Ramzan, AA; Sheeder, J; Tayebnejad, A; Wheeler, LJ, 2020
)
0.56
"68), adverse events, medication adherence, or quality of life between the groups."( Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.
Babayan, LM; Behbakht, K; Breed, CA; Brennecke, A; Cheng, G; Corr, BR; Flink, D; Guntupalli, SR; Lefkowits, C; Matsuo, K; Ramzan, AA; Sheeder, J; Tayebnejad, A; Wheeler, LJ, 2020
)
0.56
" The outcomes evaluated were the incidence of venous thromboembolic disease and the proportion of adverse events in each group."( Efficacy and safety of bemiparin compared with enoxaparin: Meta-analysis of randomized controlled trials.
Ena, J; Valls, V, 2020
)
0.56
"Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated."( Efficacy and safety of bemiparin compared with enoxaparin: Meta-analysis of randomized controlled trials.
Ena, J; Valls, V, 2020
)
0.56
"NWS anticoagulation therapy was effective and safe in PVT patients with cirrhosis and could increase the level of albumin."( Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients: A Randomized Controlled Trial.
Chen, X; Cheng, B; Gao, Y; Li, Y; Sun, X; Zhou, T, 2020
)
0.56
" The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events."( Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE.
Fang, Z; Hu, X; Liu, Q; Tang, L; Xiao, Y; Zhou, S, 2022
)
0.72
" To the best of our knowledge this is the first thrombotic coronary side effect ever reported."( Coronary Plaque Erosion after Abemaciclib Treatment Onset: An Unknown Side Effect?
Alfonso, F; Alvarado-Casas, T; Rivero, F; Salamanca, J; Vera, A, 2021
)
0.62
" Tinzaparin represents a safe choice for special populations at increased risk for thrombosis and bleeding."( Tinzaparin Safety in Patients With Cancer and Renal Impairment: A Systematic Review.
Dimakakos, EP; Syrigos, NK; Vathiotis, IA,
)
0.13
"Short-term (3 days) use of enoxaparin was shown to be effective and safe for VTE prophylaxis, comparable to regular use (at least 7 days), in postoperative management of gastric cancer surgery."( Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study.
Fujiwara, T; Hinotsu, S; Kagawa, S; Kakiuchi, Y; Kikuchi, S; Kuroda, S; Kuwada, K; Nishizaki, M; Tsumura, T; Watanabe, M, 2021
)
0.62
" The only registered antidote for ENX, protamine sulfate (PS), has 60% efficacy and can cause severe adverse side effects."( Reversal Activity and Toxicity of Heparin-Binding Copolymer after Subcutaneous Administration of Enoxaparin in Mice.
Kalaska, B; Miklosz, J; Mogielnicki, A; Pawlak, D; Swieton, J; Szczubialka, K; Yusa, SI, 2021
)
0.62
"Heparin-induced thrombocytopenia (HIT) is a serious adverse drug reaction due to its related risk of life- and limb-threatening thrombosis."( An Open-Label, Single-Arm, Pilot Intervention Study to Assess the Efficacy and Safety of Apixaban in Heparin-Induced Thrombocytopenia.
Ansarinejad, N; Balouchzehi, S; Farasatinasab, M; Moghaddam, OM; Mohammadi, M; Nasiripour, S, 2022
)
0.72
"This single-center study suggests that DOACs are both safe and efficacious for the treatment of VTE in children with cancer."( Safety and Efficacy of Direct Oral Anticoagulants for Treatment of Venous Thromboembolism in Pediatric Oncology Patients.
Branchford, B; Liegl, M; Malec, L; Scheuermann, A; Simpson, P, 2023
)
0.91
"Our results indicate that ODE, used after the initial TDE treatment period, is as safe and efficacious as TDE maintenance for the treatment of pediatric VTE."( Once-daily Compared With Twice-daily Enoxaparin Maintenance Therapy Appears Safe and Efficacious in Pediatric Venous Thromboembolism.
Addy, K; Brown, D; Gibson, A; Hashmi, SS; Menon, N; Montanez, N; Rodriguez, N; Srivaths, L, 2023
)
0.91
"The primary safety end point was bleeding events, as defined by the International Society on Thrombosis and Haemostasis, and the primary efficacy end point was major adverse cardiovascular events (MACEs), including cardiac death, myocardial infarction, rerevascularization, or stroke during the 6-month follow-up."( Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome: The H-REPLACE Randomized Equivalence and Noninferiority Trial.
Chen, F; Fu, G; Ge, L; Huang, L; Jiang, W; Liu, C; Liu, Q; Ouyang, Z; Pan, G; Pan, H; Shen, Q; Xiao, Y; Zeng, G; Zhang, Y; Zheng, Z; Zhou, C; Zhou, S; Zhu, C, 2023
)
0.91
" No serious adverse reactions occurred in the two groups during treatment."( Efficacy and safety of salvianolate and enoxaparin in the prevention of perioperative deep venous thrombosis in gastrointestinal surgery.
Chai, YN; Lu, YY; Qin, CZ; Wang, XR; Wu, ML; Zhang, JM; Zhang, WD, 2023
)
0.91
"Four national adverse event databases were examined over a 12-year period for incidence and brands involved with injury events to staff using enoxaparin prefilled syringes."( Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study.
Crutchfield, LF; Grimmond, T; Gruden, M; Hurst, BJ, 2023
)
0.91
"The search revealed 581 adverse events (including 20 sharps injuries) associated with device malfunction in 8 of 16 brands, with one brand mentioned significantly more frequently than others."( Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study.
Crutchfield, LF; Grimmond, T; Gruden, M; Hurst, BJ, 2023
)
0.91
" Conducting root cause analyses on all SI is essential, as is the need for regularly evaluating safer devices, reporting all device incidents, enabling simpler reporting of adverse events, and establishing more effective intervention by FDA and manufacturers."( Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study.
Crutchfield, LF; Grimmond, T; Gruden, M; Hurst, BJ, 2023
)
0.91
"Four national adverse event databases were examined over a 12-year period for incidence and brands involved with injury events to staff using enoxaparin prefilled syringes."( Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study.
Crutchfield, LF; Grimmond, T; Gruden, M; Hurst, BJ, 2023
)
0.91
"The search revealed 581 adverse events (including 20 sharps injuries) associated with device malfunction in 8 of 16 brands, with one brand mentioned significantly more frequently than others."( Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study.
Crutchfield, LF; Grimmond, T; Gruden, M; Hurst, BJ, 2023
)
0.91
" Conducting root cause analyses on all SI is essential, as is the need for regularly evaluating safer devices, reporting all device incidents, enabling simpler reporting of adverse events, and establishing more effective intervention by FDA and manufacturers."( Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study.
Crutchfield, LF; Grimmond, T; Gruden, M; Hurst, BJ, 2023
)
0.91

Pharmacokinetics

The present trial was designed to comparatively investigate the pharmacokinetic profile of three already marketed low molecular mass heparins (LMMHs): dalteparin (Fragmin), nadroparin (Fraxiparin), and enoxaparin (Lovenox)

ExcerptReferenceRelevance
"The present trial was designed to comparatively investigate the pharmacokinetic profile and evaluate the apparent bioavailability pattern of three already marketed low molecular mass heparins (LMMHs): dalteparin (Fragmin), nadroparin (Fraxiparin), and enoxaparin (Lovenox) given by subcutaneous route."( Comparison of the pharmacokinetic profiles of three low molecular mass heparins--dalteparin, enoxaparin and nadroparin--administered subcutaneously in healthy volunteers (doses for prevention of thromboembolism).
Bouthier, J; Caplain, H; Collignon, F; Frydman, A; Le Roux, Y; Ozoux, ML; Thébault, JJ, 1995
)
0.71
"This study compares the pharmacokinetic and the antithrombotic properties of two pentasaccharides with high affinity to antithrombin III with those of a conventional low molecular weight heparin, CY216, in the rabbit."( Pharmacokinetic and antithrombotic properties of two pentasaccharides with high affinity to antithrombin III in the rabbit: comparison with CY216.
Boneu, B; Caranobe, C; Carrie, D; Houin, G; Lormeau, JC; Meuleman, D; Petitou, M; Saivin, S; Van Boeckel, C, 1994
)
0.29
" However, the pharmacokinetics of ardeparin could be characterized by using pharmacodynamic measurements of plasma aXa activity."( The dose proportionality of the pharmacokinetics of ardeparin, a low molecular weight heparin, in healthy volunteers.
Chiang, S; Fruncillo, R; Holloway, S; Mammen, E; Ozawa, T; Troy, S, 1995
)
0.29
" To determine the impact of method of production on their pharmacokinetic and ex vivo biological properties, two LMW heparins of similar molecular weight distribution, Logiparin and Fragmin, were radiolabelled with 125I, administered intravenously with 4 mg/kg of carrier drug into rabbits, and the circulating radiolabelled material and anti-Xa activity were analysed by size exclusion chromatography and affinity for antithrombin and Polybrene."( Production method affects the pharmacokinetic and ex vivo biological properties of low molecular weight heparins.
Brieger, D; Dawes, J, 1997
)
0.3
" The present study investigates if the physiological deterioration of renal function associated with normal aging or the presence of an acute venous thromboembolism influences the pharmacodynamic pattern of the anti-factor Xa and anti-thrombin activities."( Aging and venous thromboembolism influence the pharmacodynamics of the anti-factor Xa and anti-thrombin activities of a low molecular weight heparin (nadroparin).
Boneu, B; d'Azemar, P; Decousus, H; Duret, JP; Gaud, C; Laporte-Simitsidis, S; Mismetti, P; Navarro, C; Necciari, J; Sié, P, 1998
)
0.3
"Seventeen women with previously verified thromboembolism were included in a pharmacokinetic evaluation of dalteparin during the third trimester of pregnancy."( A pharmacokinetic study of dalteparin (Fragmin) during late pregnancy.
Blombäck, M; Bremme, K; Hellgren, M; Lindberg, H, 1998
)
0.81
" A population study was undertaken to determine pharmacokinetic parameters after nadroparin calcium (Fraxiparine) administration and the effects of potential covariates; this study included 154 children divided into two groups: a model group (124 patients) and a validation group (30 patients)."( Population pharmacokinetic of nadroparin calcium (Fraxiparine) in children hospitalised for open heart surgery.
Decousus, H; Doubine, S; Laporte, S; Mismetti, P; Piquet, P; Touchot, A, 1999
)
0.3
" The objectives of this investigation were to characterize the safety and pharmacokinetic behavior of a low-molecular weight heparin (reviparin) administered throughout pregnancy."( Pharmacokinetic profile of a low-molecular weight heparin (reviparin) in pregnant patients. A prospective cohort study.
Crowther, MA; Crowther, R; Ginsberg, J; Johnston, M; Julian, J; Laskin, C; Spitzer, K, 2000
)
0.31
" The pharmacokinetic values of V and CL were estimated, for each patient, using the Bayesian maximum a posteriori method with the program ABBOTTBASE."( The effect of body weight on dalteparin pharmacokinetics. A preliminary study.
Duffull, SB; Yee, JY, 2000
)
0.6
"Prospective, single-dose pharmacokinetic study."( The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease.
Brophy, DF; Comstock, TJ; Gehr, TW; Venitz, J; Wazny, LD, 2001
)
0.31
"6 ml/minute and there was a 2-fold prolongation in antifactor Xa activity half-life compared with values reported in healthy subjects."( The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease.
Brophy, DF; Comstock, TJ; Gehr, TW; Venitz, J; Wazny, LD, 2001
)
0.31
"The objective of our study was to define the interaction between either unfractionated heparin (UFH) or a low molecular weight heparin, reviparin (REV), and the pharmacodynamic profile of the GPIIb/IIIa-antagonists abciximab (ABC) or tirofiban (T)."( Pharmacodynamic characterization of the interaction between abciximab or tirofiban with unfractionated or a low molecular weight heparin in healthy subjects.
Breddin, HK; Esslinger, HU; Graff, J; Harder, S; Kirchmaier, CM; Klinkhardt, U; Westrup, D, 2001
)
0.31
" The pharmacodynamic effects measured were bleeding time (BT), fibrinogen-binding at the GPIIb/IIIa-receptor (FIB), expression of the platelet secretion marker CD62, and ADP (20 microM)- and collagen (5 microg ml(-1))-induced platelet aggregation."( Pharmacodynamic characterization of the interaction between abciximab or tirofiban with unfractionated or a low molecular weight heparin in healthy subjects.
Breddin, HK; Esslinger, HU; Graff, J; Harder, S; Kirchmaier, CM; Klinkhardt, U; Westrup, D, 2001
)
0.31
" The results show that administration of reviparin together with abciximab or tirofiban did not adversely affect the pharmacodynamic profile of these GPIIb/IIIa-antagonists."( Pharmacodynamic characterization of the interaction between abciximab or tirofiban with unfractionated or a low molecular weight heparin in healthy subjects.
Breddin, HK; Esslinger, HU; Graff, J; Harder, S; Kirchmaier, CM; Klinkhardt, U; Westrup, D, 2001
)
0.31
"We conducted population anticoagulant pharmacodynamic analysis for patients administered the low-molecular weight heparin tinzaparin."( Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis.
Barrett, JS; Gastonguay, M; Gibiansky, E; Hainer, JW; Hua, TA; Hull, RD; Pentikis, H; Planès, A, 2001
)
0.31
"Data from 425 patients (2,631 observations) who participated in 2 Phase III clinical studies were utilized in an analysis based on a pharmacodynamic structural model of anti-Xa activity using non-linear mixed effects modeling techniques."( Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis.
Barrett, JS; Gastonguay, M; Gibiansky, E; Hainer, JW; Hua, TA; Hull, RD; Pentikis, H; Planès, A, 2001
)
0.31
"We report the pharmacodynamic properties of tinzaparin (175 U/kg antifactor Xa) given as a single daily administration for 5 consecutive days to 14 healthy volunteers as a known safe, effective treatment of deep vein thrombosis and pulmonary embolism."( The pharmacodynamics of tinzaparin in healthy volunteers.
Boneu, B; Cambus, JP; Caplain, H; Heilmann, JJ; Houin, G; Saivin, S, 2002
)
0.31
" The elimination half-life increased with the degree of renal impairment, and this relationship was more evident after repeated dosing."( Pharmacokinetics and pharmacodynamics of the prophylactic dose of enoxaparin once daily over 4 days in patients with renal impairment.
Boutouyrie, BX; Guimart, CG; Jariwala, NU; Ozoux, ML; Sanderink, GJ; Shukla, UA, 2002
)
0.31
"This pharmacodynamic study examined weight-based dosing of the low molecular weight heparin (LMWH), tinzaparin, in heavyweight/obese subjects."( Dosing in heavy-weight/obese patients with the LMWH, tinzaparin: a pharmacodynamic study.
Assaid, CA; Barrett, JS; Cox, DS; Fossler, MJ; Hainer, JW; Leathers, T; Leese, PT, 2002
)
0.31
"The pharmacokinetic and pharmacodynamic profiles after enoxaparin administration are consistent across a broad range of patients with ACS."( Influence of patient characteristics and renal function on factor Xa inhibition pharmacokinetics and pharmacodynamics after enoxaparin administration in non-ST-segment elevation acute coronary syndromes.
Antman, EM; Ball, SP; Becker, RC; Gibson, M; Murphy, SA; Rush, JE; Sanderink, G; Spencer, FA, 2002
)
0.31
"To determine pharmacokinetic variables and to evaluate the influence on clotting times after SC administration of single doses of dalteparin and enoxaparin to horses."( Comparison of pharmacokinetic variables for two low-molecular-weight heparins after subcutaneous administration of a single dose to horses.
Braun, U; Feige, K; Schwarzwald, CC; Wunderli-Allenspach, H, 2002
)
0.52
" Plasma anti-Xa activities and clotting times were measured, and pharmacokinetic variables were determined."( Comparison of pharmacokinetic variables for two low-molecular-weight heparins after subcutaneous administration of a single dose to horses.
Braun, U; Feige, K; Schwarzwald, CC; Wunderli-Allenspach, H, 2002
)
0.31
"We address the problem of the choice and the evaluation of designs in population pharmacokinetic studies that use non-linear mixed-effects models."( Fisher information matrix for non-linear mixed-effects models: evaluation and application for optimal design of enoxaparin population pharmacokinetics.
Bruno, R; Mentré, F; Retout, S, 2002
)
0.31
" Pharmacodynamic analysis of activated partial thromboplastin time showed similar results in obese and nonobese volunteers after both intravenous and subcutaneous administration."( The pharmacokinetics and pharmacodynamics of enoxaparin in obese volunteers.
Boutouyrie, B; Harding, N; Jariwala, N; Le Liboux, A; Miro, A; Montay, G; Ozoux, ML; Sanderink, GJ; Shukla, U, 2002
)
0.31
" The ex vivo analysis revealed striking pharmacodynamic and pharmacokinetic differences between the three heparins."( Pharmacokinetic and pharmacodynamic characterization of a medium-molecular-weight heparin in comparison with UFH and LMWH.
Alban, S; Hemker, HC; Welzel, D, 2002
)
0.31
"The low molecular weight heparin (LMWH), reviparin-sodium was studied in dose-finding and pharmacokinetic studies in children with central venous lines (CVLs)."( Dose-finding and pharmacokinetic profiles of prophylactic doses of a low molecular weight heparin (reviparin-sodium) in pediatric patients.
Andrew, M; Bacher, P; Chan, AK; Gent, M; Julian, JA; Kohne, S; Marzinotto, V; Massicotte, P; Shepherd, S; Shields, K; Szechtman, B, 2003
)
0.32
" The pharmacokinetic study was performed in 19 patients, 9 less than or equal to 5 kg (7 of whom were less than 3 months) and 10 greater than 5 kg (all more than 3 months)."( Dose-finding and pharmacokinetic profiles of prophylactic doses of a low molecular weight heparin (reviparin-sodium) in pediatric patients.
Andrew, M; Bacher, P; Chan, AK; Gent, M; Julian, JA; Kohne, S; Marzinotto, V; Massicotte, P; Shepherd, S; Shields, K; Szechtman, B, 2003
)
0.32
" The pharmacokinetic study demonstrated that 80% of anti-factor Xa levels were within the target range with both patient groups having similar peak (average=0."( Dose-finding and pharmacokinetic profiles of prophylactic doses of a low molecular weight heparin (reviparin-sodium) in pediatric patients.
Andrew, M; Bacher, P; Chan, AK; Gent, M; Julian, JA; Kohne, S; Marzinotto, V; Massicotte, P; Shepherd, S; Shields, K; Szechtman, B, 2003
)
0.32
"The pharmacokinetic profile of enoxaparin was established in a substudy involving 1054 patients undergoing percutaneous coronary intervention."( Pharmacokinetics of enoxaparin in patients undergoing percutaneous coronary intervention with and without glycoprotein IIb/IIIa therapy.
Argenti, D; Fareed, J; Heald, D; Hoppensteadt, D; Jensen, B,
)
0.13
"Recently, methods for computing D-optimal designs for population pharmacokinetic studies have become available."( Prospective evaluation of a D-optimal designed population pharmacokinetic study.
Duffull, SB; Green, B, 2003
)
0.32
"Enoxaparin is a low-molecular-weight heparin (LMWH) that differs substantially from unfractionated heparin (UFH) in its pharmacodynamic and pharmacokinetic properties."( Pharmacodynamic and pharmacokinetic properties of enoxaparin : implications for clinical practice.
Fareed, J; Hoppensteadt, D; Iqbal, O; Jeske, W; Ma, Q; Sheikh, T; Walenga, J, 2003
)
0.32
" A population pharmacokinetic analysis was conducted and individual estimates of enoxaparin clearance and area under the curve were tested as prognostic factors for the occurrence of haemorrhagic episodes."( Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction.
Antman, EM; Baille, P; Becker, R; Bruno, R; Retout, S; Sanderink, GJ; Veyrat-Follet, C; Vivier, N, 2003
)
0.32
" The pharmacokinetic model showed that only weight improved the predicted vs observed anti-Xa activity plot."( Pharmacokinetics of the low molecular weight heparin enoxaparin during 48 h after bolus administration as an anticoagulant in haemodialysis.
Berland, Y; Brunet, P; Dussol, B; Guillet, B; Lorec-Penet, AM; Portugal, H; Sampol, JJ; Simon, N, 2003
)
0.32
"The objective of this study was to evaluate the pharmacokinetic response to intravenous (IV) enoxaparin given 8-12 hr after subcutaneous (SC) dosing in patients undergoing percutaneous coronary intervention (PCI)."( Reliable anticoagulation with enoxaparin in patients undergoing percutaneous coronary intervention: The pharmacokinetics of enoxaparin in PCI (PEPCI) study.
Atherley, TH; Bigonzi, F; Chevalier, PJ; Fry, ET; Guimart, CM; Martin, JL; Ozoux, ML; Pensyl, CE; Sanderink, GJ, 2004
)
0.32
" The elimination half-life was approximately 1 hour."( Pharmacodynamic considerations in the selection of dosage of tinzaparin for various indications: experimental studies in primates.
Fareed, J; Jeske, W, 2004
)
0.32
" Only pharmacokinetic studies exist to guide dose adjustment in response to anti-Xa levels."( Retrospective evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment.
Kruse, MW; Lee, JJ, 2004
)
0.32
"A pharmacokinetic program was created in response to adverse events and physician interest in a service."( Retrospective evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment.
Kruse, MW; Lee, JJ, 2004
)
0.32
" However, the more predictable pharmacokinetic profiles of low molecular weight heparins are largely based on anti-Xa activity, while antithrombin activity may be at least as important to their mechanisms of action."( Pharmacokinetics of UH and LMWH are similar with respect to antithrombin activity.
Jacobson, A; Lane, JR; Marsh, JJ; Morris, TA, 2005
)
0.33
"We performed a clinical pharmacokinetic trial to compare the variability in peak antithrombin effect between subcutaneous unfractionated heparin and various LMWHs, all given in recommended weight-adjusted treatment doses."( Pharmacokinetics of UH and LMWH are similar with respect to antithrombin activity.
Jacobson, A; Lane, JR; Marsh, JJ; Morris, TA, 2005
)
0.33
"The aim of this report is to describe the use of WinBUGS for two datasets that arise from typical population pharmacokinetic studies."( Analysis of population pharmacokinetic data using NONMEM and WinBUGS.
Duffull, SB; Green, B; Holford, NH; Kirkpatrick, CM, 2005
)
0.33
" Similar TFPI (3-fold above basal at peak) and NO pharmacodynamic profiles for tinzaparin at 75 anti-Xa IU/kg were demonstrated in obese and in normal healthy subjects."( Pharmacodynamic effects of low molecular weight heparin in obese subjects following subcutaneous administration of 75 IU/kg on plasma tissue factor pathway inhibitor and nitric oxide.
Johansen, K; Mousa, SA, 2005
)
0.33
"Data suggest a normal responsiveness of vascular endothelial cells and other cellular compartments to tinzaparin with regard to the pharmacodynamic profiles of plasma TFPI and NO in obese subjects."( Pharmacodynamic effects of low molecular weight heparin in obese subjects following subcutaneous administration of 75 IU/kg on plasma tissue factor pathway inhibitor and nitric oxide.
Johansen, K; Mousa, SA, 2005
)
0.33
" Both population pharmacokinetic analysis using nonlinear mixed-effect modeling techniques and model-independent pharmacokinetic methods were employed."( Dose-finding and pharmacokinetics of therapeutic doses of tinzaparin in pediatric patients with thromboembolic events.
Chan, A; Dinyari, M; Kuhle, S; Marzinotto, V; Massicotte, P; Mitchell, D; Mitchell, LG; Pieniaszek, H; Vegh, P, 2005
)
0.33
" It was the objective of this study to evaluate the pharmacokinetic (PK) parameters of dalteparin in patients receiving chronic HD for end-stage renal disease."( A multi-dose pharmacokinetic study of dalteparin in haemodialysis patients.
Byrne, S; O'Shea, SI; Ortel, TL; Perry, SL; Szczech, LA, 2006
)
0.83
" Maximum A Posteriori Bayesian (MAPB) priors were developed by pharmacokinetic analysis."( Development of an efficient sampling strategy to predict enoxaparin pharmacokinetics in stage 5 chronic kidney disease.
Brophy, DF; Overholser, BR; Sowinski, KM, 2006
)
0.33
" As this accumulation depends on heparin chain length and subsequent reticulo-endothelial/renal elimination, LMWHs might have different pharmacodynamic profiles."( Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function: a comparative pharmacokinetic study.
Aghassarian, M; Bal Dit-Sollier, C; Bergmann, JF; Drouet, L; Heilmann, JJ; Lacut, K; Mahé, I; Mottier, D, 2007
)
0.34
" Using enoxaparin pharmacokinetic parameters to simulate anti-Xa time profiles, we observed that the maintenance of the same doses throughout pregnancy resulted in a progressive reduction in mean and peak anti-Xa activities."( Changes in enoxaparin pharmacokinetics during pregnancy and implications for antithrombotic therapeutic strategy.
Amoura, Z; Ankri, A; Conard, J; Cornet, A; Costedoat-Chalumeau, N; Dommergues, M; Hulot, JS; Lebaudy, C; Lechat, P; Piette, JC; Serreau, R, 2008
)
0.35
" The pharmacodynamic properties of dalteparin were assessed by serial anti-Xa levels measured on days 3, 10, and 17."( Prophylaxis against deep vein thrombosis in critically ill patients with severe renal insufficiency with the low-molecular-weight heparin dalteparin: an assessment of safety and pharmacodynamics: the DIRECT study.
Albert, M; Anderson, D; Cook, D; Crowther, M; Douketis, J; Fowler, R; Freitag, A; Geerts, W; Granton, J; Guyatt, G; Hébert, P; Heels-Ansdell, D; Marshall, J; Meade, M; Pagliarello, G; Rabbat, C; Skrobik, Y; Zytaruk, N, 2008
)
0.83
"We evaluated the early pharmacodynamic profile of the combined 30 mg intravenous and 1 mg/kg subcutaneous enoxaparin loading utilized in the TIMI 11B and ExTRACT TIMI 25 trials."( The pharmacodynamics of enoxaparin in percutaneous coronary intervention with precise rapid enoxaparin loading (PEPCI-PRE study).
Atherley, TH; Fry, ET; Martin, JL; Martin, SS; Martin, T; Slepian, MJ, 2009
)
0.35
" We conclude that both UFH and LMWH are cleared by HARE/Stab2 and that the differences in the affinities of HARE binding to LMWH and UFH likely explain the longer in vivo circulating half-life of LMWH compared with UFH."( Rat and human HARE/stabilin-2 are clearance receptors for high- and low-molecular-weight heparins.
Baggenstoss, BA; Harris, EN; Weigel, PH, 2009
)
0.35
"The aim of this study was to evaluate the pharmacodynamic parameters of two doses of the LMWH parnaparin administered to patients undergoing bariatric surgery."( Pharmacodynamics of low molecular weight heparin in patients undergoing bariatric surgery: a prospective, randomised study comparing two doses of parnaparin (BAFLUX study).
Baldini, E; Cini, M; De Paoli, M; Guerra, M; Imberti, D; Legnani, C; Nicolini, A; Palareti, G; Zanardi, A, 2009
)
0.35
" The pharmacodynamic effects of parnaparin were analysed by measuring the anti Factor Xa activity on day 0 (12 hours after the first parnaparin injection), day 4 and day 6 after surgery (before and 4 hours after parnaparin administration)."( Pharmacodynamics of low molecular weight heparin in patients undergoing bariatric surgery: a prospective, randomised study comparing two doses of parnaparin (BAFLUX study).
Baldini, E; Cini, M; De Paoli, M; Guerra, M; Imberti, D; Legnani, C; Nicolini, A; Palareti, G; Zanardi, A, 2009
)
0.35
"Unfractionated heparin has been the standard heparin used in human and veterinary medicine for its anticoagulation effect; however, it has a complex pharmacodynamic profile that requires close monitoring."( Pharmacokinetics of subcutaneous low molecular weight heparin (enoxaparin) in dogs.
Brooks, M; Langston, VC; Lunsford, KV; Mackin, AJ,
)
0.13
"This study was conducted to compare the pharmacodynamic time-course of two LMWHs, bemiparin and enoxaparin, at high prophylactic doses."( Comparative pharmacodynamic time-course of bemiparin and enoxaparin in healthy volunteers.
Antonijoan, RM; Barbanoj, MJ; Borrell, M; Fontcuberta, J; Martínez-González, J; Rico, S; Valcarcel, D, 2009
)
0.35
"This was an open, randomized, single-blind, cross-over study to compare the pharmacodynamic time-course, safety and tolerability of two LMWHs, bemiparin 3500 IU and enoxaparin 4000 IU at subcutaneous single doses in 12 healthy male volunteers."( Comparative pharmacodynamic time-course of bemiparin and enoxaparin in healthy volunteers.
Antonijoan, RM; Barbanoj, MJ; Borrell, M; Fontcuberta, J; Martínez-González, J; Rico, S; Valcarcel, D, 2009
)
0.35
"Low molecular weight heparin (LMWH) is used as an anticoagulant in cats although only limited pharmacokinetic data are available in this species."( Pharmacokinetics of the low molecular weight heparin dalteparin in cats.
Böhm, C; Kietzmann, M; Mischke, R; Schmitt, J; Wolf, P; Wolken, S, 2012
)
0.63
"Physiological changes during pregnancy can effect pharmacokinetic (PK) parameters, which may lead to altered dose requirements."( Leveraging physiological data from literature into a pharmacokinetic model to support informative clinical study design in pregnant women.
Green, B; Morrish, GA; van Hasselt, JG, 2012
)
0.38
" The aim of this study was to investigate whether, and to what extent, a switch from enoxparin to dabigatran etexilate affects the pharmacokinetic (PK) and pharmacodynamic (PD) parameters and safety profile of dabigatran."( Switching from enoxaparin to dabigatran etexilate: pharmacokinetics, pharmacodynamics, and safety profile.
Clemens, A; Feuring, M; Härtter, S; Sennewald, R; Stangier, J; van Ryn, J; Yamamura, N, 2012
)
0.38
" Pharmacokinetic differences were not observed using anti-Xa or Heptest assays."( A comparison of the pharmacodynamic behavior of branded and biosimilar enoxaparin in primates.
Fareed, J; Hoppensteadt, D; Jeske, W; Khan, H; Litinas, E, 2012
)
0.38
" Serial blood samples were collected for PD (thrombin generation, anti-FXa) and pharmacokinetic (PK) variables (edoxaban and its principal metabolite M4 by LC-MS/MS, and anti-FIIa as a surrogate of enoxaparin)."( Edoxaban administration following enoxaparin: a pharmacodynamic, pharmacokinetic, and tolerability assessment in human subjects.
Halim, AB; He, L; Lee, F; Matsushima, N; Mendell, J; Worland, V; Zahir, H; Zhang, G, 2012
)
0.38
"The main HGF pharmacokinetic parameters were evaluated following acute and chronic LMWH treatment."( Daily administration of low molecular weight heparin increases Hepatocyte Growth Factor serum levels in gynaecological patients: pharmacokinetic parameters and clinical implications.
Di Renzo, MF; Ferrero, A; Fuso, L; Luchin, A; Marchese, C; Martino, C; Passera, R; Surbone, A; Zola, P, 2012
)
0.38
"In the short-term treated group, median HGF AUCss, Cmax and Caverage were about four-fold that of the control group, whereas Cmin was three-fold."( Daily administration of low molecular weight heparin increases Hepatocyte Growth Factor serum levels in gynaecological patients: pharmacokinetic parameters and clinical implications.
Di Renzo, MF; Ferrero, A; Fuso, L; Luchin, A; Marchese, C; Martino, C; Passera, R; Surbone, A; Zola, P, 2012
)
0.38
"To evaluate the pharmacodynamic effects of dalteparin in dogs by means of viscoelastic coagulation monitoring with a thromboelastograph and a dynamic viscoelastic coagulometer."( Viscoelastic pharmacodynamics after dalteparin administration to healthy dogs.
Babski, DM; Blong, AE; Brainard, BM; Koenig, A; Scherk, JR, 2012
)
0.92
"The aim of this study was to develop a novel population pharmacokinetic (PPK) model of dalteparin after subcutaneous (s."( Low-molecular-weight heparin pharmacokinetics: a dual absorption model approach.
Abe, S; Chiba, K; Suwa, T, 2013
)
0.61
" injection, the apparent elimination half-life of the dalteparin was about 4 hours, longer than that reported after intravenous (i."( Low-molecular-weight heparin pharmacokinetics: a dual absorption model approach.
Abe, S; Chiba, K; Suwa, T, 2013
)
0.64
" The physiological changes associated with pregnancy alter the pharmacokinetic profile of low-molecular-weight heparins, which has led to controversy and subsequent variation in practice, when pregnant women with venous thromboembolism are treated with low-molecular-weight heparins."( Population pharmacokinetics of enoxaparin during the antenatal period.
Arya, R; Davies, JG; Green, B; Marsh, MS; Patel, JP; Patel, RK, 2013
)
0.39
" Compartmental pharmacokinetic modeling was conducted using nonlinear mixed-effects modeling."( Population pharmacokinetics of enoxaparin during the antenatal period.
Arya, R; Davies, JG; Green, B; Marsh, MS; Patel, JP; Patel, RK, 2013
)
0.39
"The half-life of enoxaparin is prolonged with the progression of pregnancy, and our work provides compelling evidence for prescribing once-daily enoxaparin for the treatment of antenatal venous thromboembolism."( Population pharmacokinetics of enoxaparin during the antenatal period.
Arya, R; Davies, JG; Green, B; Marsh, MS; Patel, JP; Patel, RK, 2013
)
0.39
"The pharmacokinetic curve suggests a zero-order process of elimination."( Pharmacokinetics of dalteparin during haemodialysis.
de Groot, KA; Grootendorst, DC; Herruer, MH; Koolen, SL; Nigten, J; Schut, NH, 2013
)
0.71
"Detailed pharmacokinetic data are not available for subcutaneously (SC) administered enoxaparin in cats and this causes difficulties in establishing treatment protocols."( Enoxaparin: pharmacokinetics and treatment schedule for cats.
Böhm, C; Döderlein, E; Kietzmann, M; Mischke, R; Schönig, J; Wolken, S, 2014
)
0.4
"The objective of this study was to determine the impact of a pharmacy-managed pharmacokinetic dosing program on appropriate dosing of famotidine, enoxaparin, and ketorolac."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
"A large community teaching hospital implemented a pharmacy-managed pharmacokinetic dosing program for famotidine, enoxaparin, and ketorolac."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
"Implementation of a pharmacy-managed pharmacokinetic dosing program significantly improved appropriate dosing of famotidine, enoxaparin, and ketorolac."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
" In order to guide dosing in this patient group, a pharmacodynamics model is developed for nadroparin in morbidly obese and non-obese patients using anti-Xa levels as an endpoint, thereby characterizing the influence of excessive body weight on different pharmacodynamic model parameters."( Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint.
Diepstraten, J; Hackeng, CM; Janssen, EJ; Knibbe, CA; van Dongen, EP; van Ramshorst, B; Wiezer, RJ, 2015
)
0.42
" Population pharmacodynamic modelling with covariate analysis was performed using NONMEM."( Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint.
Diepstraten, J; Hackeng, CM; Janssen, EJ; Knibbe, CA; van Dongen, EP; van Ramshorst, B; Wiezer, RJ, 2015
)
0.42
"In a two-compartment pharmacodynamic model with baseline endogenous anti-Xa levels, the effect of nadroparin was found to be delayed and could be best described using a transit compartment."( Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint.
Diepstraten, J; Hackeng, CM; Janssen, EJ; Knibbe, CA; van Dongen, EP; van Ramshorst, B; Wiezer, RJ, 2015
)
0.42
"The pharmacokinetic properties of enoxaparin may lead to supratherapeutic antifactor Xa (anti-Xa) levels and increased bleeding when standard treatment doses are used in patients with morbid obesity."( Evaluation and Pharmacokinetics of Treatment Dose Enoxaparin in Hospitalized Patients With Morbid Obesity.
Chandler, WL; Liebl, PH; Muntz, JE; Putney, DR; Thompson-Moore, NR; Wanat, MA, 2015
)
0.42
"Based on pharmacodynamic data, the majority of plastic surgery patients receive inadequate enoxaparin prophylaxis using fixed dosing."( Inadequate Enoxaparin Dosing Predicts 90-Day Venous Thromboembolism Risk among Plastic Surgery Inpatients: An Examination of Enoxaparin Pharmacodynamics.
Agarwal, J; Fleming, KI; Ghanem, M; Momeni, A; Pannucci, CJ; Rockwell, WB, 2017
)
0.46
" Population pharmacokinetic analysis was performed with NONMEM."( Enoxaparin Population Pharmacokinetics in the First Year of Life.
Galati, M; Lee-Kim, Y; Mahoney, D; Moffett, BS; Shah, MD; Teruya, J; Yee, DL, 2017
)
0.46
" Population pharmacokinetic analysis was performed with bootstrap analysis."( Population Pharmacokinetics of Enoxaparin in Pediatric Patients.
Galati, M; Lee-Kim, Y; Mahoney, D; Moffett, BS; Shah, MD; Teruya, J; Yee, D, 2018
)
0.48
" This study compared the pharmacokinetic (PK) behavior of 3 batches of ovine LMWH with that of enoxaparin in nonhuman primates."( Comparative Pharmacokinetic Profile of 3 Batches of Ovine Low-Molecular-Weight Heparin and 1 Batch of Branded Enoxaparin.
Duff, R; Fareed, J; Hoppensteadt, D; Jeske, W; Kouta, A; Niverthi, M; Rangnekar, V; Yao, Y, 2018
)
0.48
" Here we describe the results of 3 studies that evaluated the safety and tolerability of DS-1040 along with the effect on DS-1040 pharmacokinetic (PK) parameters, when dosed alone or when coadministered with aspirin (NCT02071004), clopidogrel (NCT02560688), or enoxaparin in healthy subjects."( Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin.
Dishy, V; Kobayashi, F; Kochan, J; Limsakun, T; McPhillips, P; Mendell, J; Orihashi, Y; Pav, J; Pizzagalli, F; Rambaran, C; Vandell, AG; Warren, V; Zhou, J, 2020
)
0.56
" The anti-Xa data were supplemented with 2 published studies and analyzed using population pharmacokinetic approaches."( Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism.
Damle, B; Jani, D; Jen, F; Sherman, N; Sweeney, K, 2021
)
0.89
"To develop a pharmacokinetic model of enoxaparin to predict the time-exposure profiles of various thromboprophylactic regimens in COVID-19 ICU-patients."( Pharmacokinetics of enoxaparin in COVID-19 critically ill patients.
Bauters, A; Caplan, M; Delavenne, X; Dupont, A; Goutay, J; Jean, L; Lanoiselée, J; Levy, L; Poissy, J; Susen, S; Zufferey, PJ, 2021
)
0.62
" Anti-Xa activities from consecutive patients with laboratory-confirmed SARS-CoV-2 infection treated with enoxaparin for the prevention or the treatment of venous thrombosis were used to develop a population pharmacokinetic model using non-linear mixed effects techniques."( Pharmacokinetics of enoxaparin in COVID-19 critically ill patients.
Bauters, A; Caplan, M; Delavenne, X; Dupont, A; Goutay, J; Jean, L; Lanoiselée, J; Levy, L; Poissy, J; Susen, S; Zufferey, PJ, 2021
)
0.62
"To compare the pharmacokinetic profiles of intravenous (IV) versus subcutaneous (SC) route of administration of LMWH."( Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial.
De Schryver, N; Eeckhoudt, S; Gérard, L; Laterre, PF; Serck, N; Wittebole, X, 2022
)
0.72
" Pharmacokinetic profiles were significantly different."( Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial.
De Schryver, N; Eeckhoudt, S; Gérard, L; Laterre, PF; Serck, N; Wittebole, X, 2022
)
0.72
" To further mechanistically explore obesity-associated differences in anti-Xa concentration, a pediatric physiologically-based pharmacokinetic (PBPK) model was developed in adults, and then scaled to children with and without obesity."( Use of Real-World Data and Physiologically-Based Pharmacokinetic Modeling to Characterize Enoxaparin Disposition in Children With Obesity.
Carreño, FO; Edginton, AN; Gerhart, JG; Gonzalez, D; Hornik, CP; Kirkpatrick, CM; Kumar, KR; Lee, CR; Loop, MS; Sinha, J, 2022
)
0.72
" A population pharmacodynamic model was developed using non-linear mixed-effects modelling."( Optimising the Nadroparin Dose for Thromboprophylaxis During Hemodialysis by Developing a Population Pharmacodynamic Model Using Anti-Xa Levels.
Diepstraten, J; Franssen, CFM; Jaspers, TCC; Khorsand, N; Koomen, JV; Lukens, MV; Maat, B; Meijer, CE; Touw, DJ; van den Bemt, PMLA; Vleming, LJ, 2022
)
0.72
" Despite existing population pharmacokinetic (PK) models for nadroparin in literature, the population PK of nadroparin in COVID-19 ICU patients is unknown."( Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID-19 intensive care unit patients.
Endeman, H; Hunfeld, NGM; Kruip, MJHA; Preijers, T; Romano, LGR, 2023
)
0.91
" The aim of this study was to develop a pharmacokinetic model of nadroparin according to different stages of COVID-19 severity."( Population Pharmacokinetics and Probability of Target Attainment Analysis of Nadroparin in Different Stages of COVID-19.
Borys, M; Cios, W; Czuczwar, M; Okuńska, P; Piwowarczyk, P; Raszewski, G; Szczukocka, M; Wiczling, P, 2023
)
0.91
" 27 patients (n = 68 samples) were evaluated and combined with published data (n = 319 samples from 35 patients) using population pharmacokinetic (popPK) modelling."( The effect of renal impairment and obesity on anti-Xa peak and trough levels in patients receiving therapeutic doses of nadroparin: a comparison with control patients.
Hackeng, CM; Knibbe, CAJ; Mast, L; Peeters, MYM; Söhne, M; van den Broek, MPH, 2023
)
0.91

Compound-Compound Interactions

Tirofiban combined with dalteparin was associated with relatively more bleeding complications in the short term, but was effective in reducing the incidence of MACE during long-term clinical follow-up in patients with ACS.

ExcerptReferenceRelevance
" Subtherapeutic doses of tinzaparin combined with abciximab or roxifiban resulted in a distinct synergy that improved anticoagulant and antiplatelet efficacy mediated by TF, fXa, or thrombin."( Comparative efficacy of different low-molecular-weight heparins (LMWHs) and drug interactions with LMWH: implications for management of vascular disorders.
Mousa, SA, 2000
)
0.31
" When combined with tirofiban, enoxaparin, relative to unfractionated heparin, resulted in less variability and a trend toward greater inhibition of platelet aggregation using 5 microM adenosine phosphate agonist."( Initial experience with the low-molecular-weight heparin, enoxaparin, in combination with the platelet glycoprotein IIb/IIIa blocker, tirofiban, in patients with non-ST segment elevation acute coronary syndromes.
Cohen, M, 2000
)
0.31
" The purpose of this study was to assess anticoagulant effect and clinical safety for several dose regimens of dalteparin administered in combination with abciximab during percutaneous coronary intervention (PCI)."( Dalteparin in combination with abciximab during percutaneous coronary intervention.
Aquilina, JW; Broderick, TM; Burkert, ML; DeLoof, M; Fry, E; Kereiakes, DJ; Kleiman, NS; Lengerich, R; Maresh, K; Mwawasi, G; Shimshak, TM, 2001
)
1.96
" These data suggest that enoxaparin is more effective and potentially safer than heparin when combined with a GPIIb/IIIa receptor antagonist during rt-PA-induced coronary thrombolysis."( Superiority of enoxaparin over heparin in combination with a GPIIb/IIIa receptor antagonist during coronary thrombolysis in dogs.
Bentley, RG; Bostwick, JS; Chu, V; Kasiewski, CJ; Klein, SI; Leadley, RJ; Morgan, SR; Perrone, MH; Rebello, SS, 2001
)
0.31
"Dalteparin in combination with abciximab in patients with unstable angina undergoing coronary intervention appears to be safe."( Leukocyte-platelet aggregation, platelet surface P-selectin, and platelet surface glycoprotein IIIa after percutaneous coronary intervention: Effects of dalteparin or unfractionated heparin in combination with abciximab.
Barnard, MR; Broderick, TM; Fox, ML; Frelinger, AL; Furman, MI; Howard, WL; Kereiakes, DJ; Krueger, LA; Michelson, AD; Mueller, MN; Pieper, K; Schneider, JF, 2001
)
1.95
"The antithrombotic effect of the glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist (2S)-2-[(2-naphthyl-sulfonyl)amino]-3-[[2-([4-(4-piperidinyl)-2-[2-(4-piperidinyl)ethyl] butanoyl]amino)acetyl]amino] propanoic acid dihydrochloride (CRL42796), administered alone, or in combination with aspirin, and/or enoxaparin, was examined in a canine left circumflex (LCX) coronary artery rethrombosis model."( Glycoprotein IIb/IIIa receptor antagonist (2S)-2-[(2-Naphthyl-sulfonyl)amino]-3-[[2-([4-(4-piperidinyl)-2-[2-(4-piperidinyl)ethyl] butanoyl]amino)acetyl]amino]propanoic acid dihydrochloride (CRL42796), in combination with aspirin and/or enoxaparin, preven
Driscoll, EM; Giboulot, TA; Hong, TT; Lucchesi, BR; Sherigill, A; White, AJ, 2003
)
0.32
"02) effect on the time to clot assessed with the activated clotting time was demonstrated when either eptifibatide or tirofiban was combined with aspirin and enoxaparin plus rNAPc2."( Efficiency in clinical research: assessment in vitro of potential anti-thrombotic drug interactions.
Schneider, DJ; Sobel, BE; Whitaker, DA, 2004
)
0.32
"The lack of an exaggerated effect on clotting and platelet function when GP IIb-IIIa inhibitors were combined with rNAPc2, aspirin, and enoxaparin suggests that no substantial increment in the incidence of bleeding would be observed when concentrations of rNAPc2 up to 250 ng/ml were to be used in clinical studies."( Efficiency in clinical research: assessment in vitro of potential anti-thrombotic drug interactions.
Schneider, DJ; Sobel, BE; Whitaker, DA, 2004
)
0.32
" In the present study the efficacy of tirofiban, a specific inhibitor of the platelet glycoprotein IIb/IIIa receptor, combined with heparin or low-molecular-weight heparin (dalteparin), was evaluated for the management of ACS."( Long-term clinical outcomes of platelet glycoprotein IIb/IIIa inhibitor combined with low molecular weight heparin in patients with acute coronary syndrome.
Ahn, YK; Cho, JG; Hong, SN; Hong, YJ; Jeong, MH; Kang, DK; Kang, JC; Kim, JH; Kim, KH; Kim, W; Lee, SH; Lee, YS; Lim, JH; Lim, SY; Moon, Y; Park, HW; Park, JC; Rhew, JY; Yun, KH, 2005
)
0.52
"Tirofiban combined with dalteparin was associated with relatively more bleeding complications in the short term, but was effective in reducing the incidence of MACE during long-term clinical follow-up in patients with ACS."( Long-term clinical outcomes of platelet glycoprotein IIb/IIIa inhibitor combined with low molecular weight heparin in patients with acute coronary syndrome.
Ahn, YK; Cho, JG; Hong, SN; Hong, YJ; Jeong, MH; Kang, DK; Kang, JC; Kim, JH; Kim, KH; Kim, W; Lee, SH; Lee, YS; Lim, JH; Lim, SY; Moon, Y; Park, HW; Park, JC; Rhew, JY; Yun, KH, 2005
)
0.64
"The purpose of this study was to determine the clinical outcomes of abciximab combined with the low molecular weight heparin (LMWH), dalteparin, in high-risk percutaneous coronary intervention (PCI) patients with acute myocardial infarction (AMI)."( Comparison of abciximab combined with dalteparin or unfractionated heparin in high-risk percutaneous coronary intervention in acute myocardial infarction patients.
Ahn, YK; Cho, JG; Hong, YJ; Hwang, SH; Jeong, MH; Kang, JC; Kim, KH; Kim, W; Park, JC, 2006
)
0.81
" Early surgical intervention and standard management combined with Iloprost infusion may help in healing the lesions by increasing extremity perfusion and may prevent extremity loss."( Successful surgical treatment of Nicolau's syndrome combined with intravenous iloprost.
Duman, A; Durgut, K; Gormus, N; Senaran, H; Solak Görmüs, ZI; Tanyeli, O, 2009
)
0.35
" This study aimed to determine the clinical outcomes of tirofiban combined with the low molecular weight heparin (LMWH), dalteparin, in primary PCI patients with acute STEMI."( Comparison of tirofiban combined with dalteparin or unfractionated heparin in primary percutaneous coronary intervention of acute ST-segment elevation myocardial infarction patients.
Ge, YG; Li, WM; Ni, ZH; Wang, HS; Wang, LF; Xu, L; Yang, XC; Zhang, DP, 2011
)
0.85
" The maximum tolerated dose (MTD) of lenalidomide given in combination with gemcitabine was defined as the highest dose level at which no more than one out of four (25%) subjects experiences a dose-limiting toxicity (DLT)."( A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer.
Liljefors, M; Rossmann, E; Ullenhag, GJ, 2015
)
0.42
" Most antiseptic lock solutions are made up of ethanol combined with an anticoagulant."( In vitro assessment of the anti-biofilm activity of ethanol alone and in combination with enoxaparin 60IU.
Alonso, B; Guembe, M; Pérez-Granda, MJ; Rodríguez, C; Rodríguez-Huerta, A, 2018
)
0.48
"Using a static 96-well plate in vitro model, we tested 30%, 35%, and 40% ethanol alone and combined with 60IU of enoxaparin against 24-h-old biofilm from the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, Escherichia coli, and Candida albicans."( In vitro assessment of the anti-biofilm activity of ethanol alone and in combination with enoxaparin 60IU.
Alonso, B; Guembe, M; Pérez-Granda, MJ; Rodríguez, C; Rodríguez-Huerta, A, 2018
)
0.48
"Our in vitro model demonstrated that when ethanol is combined with enoxaparin in a lock solution, it negatively affects ethanol anti-biofilm activity after both short and long exposures."( In vitro assessment of the anti-biofilm activity of ethanol alone and in combination with enoxaparin 60IU.
Alonso, B; Guembe, M; Pérez-Granda, MJ; Rodríguez, C; Rodríguez-Huerta, A, 2018
)
0.48
"Introduction: Drug-drug interactions occur more frequently in intensive care units than in other services."( Characterization of potential drug-drug interactions in patients hospitalized in the intensive care unit of a tertiary hospital in Bogotá
Bustamante, C; Hernández, M; Tribiño, G, 2018
)
0.48
"Objectives A "potential drug-drug interaction" (pDDI) is the possibility one drug has to alter the effects of another when both are administered simultaneously."( Potential drug-drug interactions in ICU patients: a retrospective study.
Ali, I; Bazzar, A; Hussein, N; Sahhar, E, 2020
)
0.56
" Hence, this real-world study aimed to explore the efficacy and safety of TNFi combined with intravenous immunoglobin (IVIG) and heparin therapy in RSA patients."( Tumour necrosis factor inhibitor combined with intravenous immunoglobulin and heparin for treatment of recurrent spontaneous abortion: A two-centre, retrospective, cohort study.
Chen, J; Chen, X; Jiang, Y; Wu, H; You, Q; Zhang, N; Zou, Q, 2022
)
0.72
"TNFi combined with IVIG and heparin therapy improves the live birth rate but does not elevate the adverse events compared to IVIG and heparin therapy in RSA patients."( Tumour necrosis factor inhibitor combined with intravenous immunoglobulin and heparin for treatment of recurrent spontaneous abortion: A two-centre, retrospective, cohort study.
Chen, J; Chen, X; Jiang, Y; Wu, H; You, Q; Zhang, N; Zou, Q, 2022
)
0.72
"This study aimed to estimate how prevalent potential drug-drug interactions (pDDIs) were in patients with cardiovascular diseases who were hospitalized for more than 24 hours, and to determine the risk factors associated with these pDDIs."( Detection and analysis of potential drug-drug interactions among patients admitted to the cardiac care unit in a tertiary care hospital.
Almaghaslah, D; Khaled, A; Makki, S; Nagib, R; Siddiqua, A, 2023
)
0.91

Bioavailability

The low molecular weight heparin (LMWH) dalteparin sodium is notable for its improved pharmacokinetic characteristics. It has increased bioavailability and plasma elimination half-life compared with unfractionated heparins (UFH)

ExcerptReferenceRelevance
"The present trial was designed to comparatively investigate the pharmacokinetic profile and evaluate the apparent bioavailability pattern of three already marketed low molecular mass heparins (LMMHs): dalteparin (Fragmin), nadroparin (Fraxiparin), and enoxaparin (Lovenox) given by subcutaneous route."( Comparison of the pharmacokinetic profiles of three low molecular mass heparins--dalteparin, enoxaparin and nadroparin--administered subcutaneously in healthy volunteers (doses for prevention of thromboembolism).
Bouthier, J; Caplain, H; Collignon, F; Frydman, A; Le Roux, Y; Ozoux, ML; Thébault, JJ, 1995
)
0.71
" Moreover, subcutaneous parnaparin has a greater bioavailability and longer half-life than heparin, permitting once-daily administration for the prophylaxis of deep venous thrombosis (DVT) or the treatment of established vascular disorders."( Parnaparin. A review of its pharmacology, and clinical application in the prevention and treatment of thromboembolic and other vascular disorders.
Faulds, D; Frampton, JE, 1994
)
0.29
"5 kD, has greater bioavailability and a longer duration of action than unfractionated heparin, allowing it to be administered once daily by subcutaneous injection for both prophylaxis and treatment of deep venous thrombosis (DVT)."( Tinzaparin. A review of its pharmacology and clinical potential in the prevention and treatment of thromboembolic disorders.
Balfour, JA; Friedel, HA, 1994
)
0.29
" However, there are several unexpected observations such as the greater than 100% bioavailability of subcutaneously administered LMWH as measured by a chromogenic based anti-Xa method."( The role of tissue factor pathway inhibitor in the mediation of the antithrombotic actions of heparin and low-molecular-weight heparin.
Bermes, EW; Fareed, J; Hoppensteadt, DA; Jeske, W, 1995
)
0.29
" Because of the better bioavailability of LMWH by the subcutaneous route at equigravimetric dosages, Ardeparin released more TFPI than UFH."( TFPI antigen levels in normal human volunteers after intravenous and subcutaneous administration of unfractionated heparin and a low molecular weight heparin.
Fareed, J; Fasanella, A; Hoppensteadt, DA; Jeske, W; Walenga, JM, 1995
)
0.29
" Low-molecular-weight heparin (LMWH) has a longer plasma half-life and better bioavailability than standard heparin and can thus be administered as a single daily injection."( Prevention of thrombotic complications of the nephrotic syndrome by the low-molecular-weight heparin enoxaparin.
Ben Maadi, A; Durand-Zaleski, I; Jazaerli, N; Mathieu, D; Petit-Phar, M; Radier, C; Rahmouni, A; Rosso, J; Rostoker, G; Vasile, N, 1995
)
0.29
" We conclude that the only functional difference between LMWH and UFH is the much higher bioavailability of the former."( Pharmacokinetics and pharmacodynamics of a low molecular weight heparin (enoxaparin) after subcutaneous injection, comparison with unfractionated heparin--a three way cross over study in human volunteers.
Béguin, S; Bendetowicz, AV; Caplain, H; Hemker, HC, 1994
)
0.29
" The enhanced bioavailability of these drugs, in conjunction with their prolonged half-life, makes subcutaneous therapy, in one to two daily doses, possible."( Low molecular weight heparins and their use in obstetrics and gynecology.
Fejgin, MD; Lourwood, DL, 1994
)
0.29
" This agent also showed sustained activity and better bioavailability characteristics than heparin."( Pharmacological profile of reviparin-sodium.
Fareed, J; Hoppensteadt, D; Jeske, W, 1993
)
0.29
" This agent also showed sustained activity and better bioavailability characteristics than heparin."( Biochemical and pharmacologic profile of low molecular weight heparin (LU 47311, Clivarin).
Ahsan, A; Fareed, J; Hoppensteadt, D; Jeske, W; Lojewski, B; Walenga, JM, 1993
)
0.29
" However, the longer plasma half-life, better bioavailability after subcutaneous administration, and more predictable anticoagulant response of low-molecular-weight heparins make them attractive for possible home use."( A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis.
Anderson, D; Demers, C; Gent, M; Ginsberg, J; Hirsh, J; Kovacs, M; Leclerc, J; Levine, M; Turpie, AG; Weitz, J, 1996
)
0.29
" The rate of absorption of ardeparin after subcutaneous administration did not change with increasing dose."( The dose proportionality of the pharmacokinetics of ardeparin, a low molecular weight heparin, in healthy volunteers.
Chiang, S; Fruncillo, R; Holloway, S; Mammen, E; Ozawa, T; Troy, S, 1995
)
0.29
"The low molecular weight heparin (LMWH) dalteparin sodium is notable for its improved pharmacokinetic characteristics (chiefly increased bioavailability and plasma elimination half-life) compared with unfractionated heparin (UFH)."( Dalteparin sodium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders.
Dunn, CJ; Sorkin, EM, 1996
)
2
" Compared with unfractionated heparin (UFH), nadroparin has a greater ratio of anti-factor Xa to anti-factor Ha activity, greater bioavailability and a longer duration of action, allowing it to be administered by subcutaneous injection for prophylaxis or treatment of thromboembolic disorders."( Nadroparin calcium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders.
Davis, R; Faulds, D, 1997
)
0.3
" The objective of this study was to evaluate the absolute and comparative bioavailability of ardeparin following subcutaneous administration of three different formulations [two formulations of ardeparin at 10,000 anti-factor Xa (aXa) U/ml, but with different preservatives, and a 20,000 aXa U/ml formulation]."( Absolute and comparative subcutaneous bioavailability of ardeparin sodium, a low molecular weight heparin.
Chiang, S; Fruncillo, R; Holloway, S; Mammen, E; Ozawa, T; Troy, S, 1997
)
0.3
" This study was designed to compare the bioavailability of 2 formulations of nadroparin containing 10,250 and 20,500 anti-Xa IU x ml(-1) respectively."( Pharmacodynamics and tolerance of two nadroparin formulations (10,250 and 20,500 anti Xa IU x ml(-1)) delivered for 10 days at therapeutic dose.
Boneu, B; Cambus, JP; Caplain, H; d'Azemar, P; Duret, JP; Gaud, C; Navarro, C; Necciari, J; Sié, P, 1998
)
0.3
" The bioavailability of morning subcutaneous administration of dalteparin (crossover study) was also compared with that in the evening."( A pharmacokinetic study of dalteparin (Fragmin) during late pregnancy.
Blombäck, M; Bremme, K; Hellgren, M; Lindberg, H, 1998
)
0.84
" UFH is limited due to its unpredictable antithrombotic effect, poor bioavailability when given subcutaneously, requirement for hospitalization and need for frequent laboratory monitoring."( Management of acute coronary syndromes with low molecular weight heparin: TIMI 11A and 11B.
Turpie, AG, 1998
)
0.3
" Due to the greater bioavailability and longer half-life of Fragmin compared with conventional heparin we postulated that this may influence postoperative bleeding after cardiac surgery for unstable angina."( Effect of low molecular weight heparin (fragmin) on bleeding after cardiac surgery.
Clark, SC; Forty, J; Vitale, N; Zacharias, J, 2000
)
0.31
" The absolute bioavailability calculated for the subcutaneous NMH-injection of 50 and 100 anti-fXaU."( [Phamacokinetics of low-molecular-weight heparins Fragmin D in dogs].
Grebe, S; Jacobs, C; Kietzmann, M; Mischke, R, 2000
)
0.31
" Comparing the rate of change between pairs of anti-Xa activity, the absorption rate was found to have decreased by over 50%."( The effect of plasmapheresis on the serum activity level of dalteparin: a case report.
Sabloff, M; Wells, PS, 2000
)
0.55
" Compared with unfractionated heparin (UFH), the drug has markedly improved bioavailability and increased plasma elimination half-life, and exerts a greater inhibitory effect on plasma activity of coagulation factor Xa relative to its effects on other coagulation parameters."( Dalteparin: an update of its pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic disease.
Dunn, CJ; Jarvis, B, 2000
)
1.75
" Because of their predictable pharmacokinetics and bioavailability after subcutaneous administration, LMWHs can be more convenient for outpatient use than UFH."( Comparative efficacy of different low-molecular-weight heparins (LMWHs) and drug interactions with LMWH: implications for management of vascular disorders.
Mousa, SA, 2000
)
0.31
" However, different LMWHs vary significantly in their pharmacokinetic profile and bioavailability pattern."( [Prospective randomized study comparing the effectiveness and tolerance of various low-molecular-weight heparins in high risk patients].
Bergauer, F; Hagena, FW; Janni, W; Lohscheidt, K; Rjosk, D, 2001
)
0.31
" However, the bioavailability of unfractionated heparin (UFH) administered through the large intestine was low."( Intestinal absorption of low molecular weight heparin in animals and human subjects.
Bar-On, H; Eldor, A; Friedman, G; Hyam, E; Kidron, M; Nissan, A; Ziv, E,
)
0.13
" Today we know that the real advantage of LMWHs is due to their high bioavailability which makes safe and reliable their subcutaneous administration without laboratory monitoring."( [State of the art: low-molecular-weight heparin and beyond].
Casali, G; Cimminiello, C; Vitali, L, 2000
)
0.31
" Compared to unfractionated heparins LMWH are user-friendly (high bioavailability after subcutaneous application, no needed routine control of plasma efficacy)."( [Low molecular weight heparins in acute coronary syndrome].
Huber, K; Niessner, A; Niessner, H, 2001
)
0.31
" Key advantages of LMWHs include improved bioavailability and longer half-life, more predictable anticoagulation that requires less laboratory monitoring, and fewer serious side effects."( Pharmacology department.
Gylys, KH, 2001
)
0.31
" The results for anti-Xa activity showed that the rate of absorption of enoxaparin was similar across the four groups of study participants."( Pharmacokinetics and pharmacodynamics of the prophylactic dose of enoxaparin once daily over 4 days in patients with renal impairment.
Boutouyrie, BX; Guimart, CG; Jariwala, NU; Ozoux, ML; Sanderink, GJ; Shukla, UA, 2002
)
0.31
" UFH had the lowest bioavailability regarding the aPTT, aXa, and aIIa activities."( Pharmacokinetic and pharmacodynamic characterization of a medium-molecular-weight heparin in comparison with UFH and LMWH.
Alban, S; Hemker, HC; Welzel, D, 2002
)
0.31
" Low-molecular-weight heparins prevent venous thrombosis as effectively as heparin and have better bioavailability and a longer plasma half-life, which explains the increased use of low-molecular-weight heparins as substitutes for heparin in clinical practice."( Low-molecular-weight heparin (dalteparin) effectively prevents thrombosis in a rat model of deep arterial injury.
Arnljots, B; Dahlbäck, B; Malm, K, 2003
)
0.61
" Enoxaparin has a higher and more consistent bioavailability after subcutaneous administration than UFH, a longer plasma half-life and is less strongly bound to plasma proteins."( Pharmacodynamic and pharmacokinetic properties of enoxaparin : implications for clinical practice.
Fareed, J; Hoppensteadt, D; Iqbal, O; Jeske, W; Ma, Q; Sheikh, T; Walenga, J, 2003
)
0.32
" Absolute and relative bioavailability of enoxaparin were increased by two-fold when the alkyl chain length of maltosides was increased from 8 to 14 carbons."( Chain length-dependent effects of alkylmaltosides on nasal absorption of enoxaparin.
Ahsan, F; Khan, MA; Mustafa, F; Yang, T, 2004
)
0.32
" The bioavailability of enoxaparin formulated with alkanoylsucroses was increased by several folds compared with enoxaparin formulated in saline."( Alkanoylsucroses in nasal delivery of low molecular weight heparins: in-vivo absorption and reversibility studies in rats.
Ahsan, F; Mustafa, F; Yang, T, 2004
)
0.32
" Due to a longer plasma half life together with high bioavailability and a linear dose-response relationship, the drugs can be safely and effectively administered in the hospital or ambulatory settings without the need to monitor the anticoagulant effect."( Clinical application of enoxaparin.
Hofmann, T, 2004
)
0.32
"Formulations containing 5% dimethyl-beta-cyclodextrin (DMbetaCD) produced the highest increase in the bioavailability of LMWH preparations tested."( Cyclodextrins in nasal delivery of low-molecular-weight heparins: in vivo and in vitro studies.
Abbruscato, TJ; Ahsan, F; Hussain, A; Paulson, J; Yang, T, 2004
)
0.32
" The drugs are marked by bioavailability approximating 100%, linear dose-dependent pharmacokinetic profile at subcutaneous injection; they do not undergo metabolism and are excreted largely with urine."( [Prevention and treatment of venous thromboses and thromboembolism: pentasaccharides as novel anticoagulants selectively blocking Xe factor, their position and potential (data of the XIX International Congress on Thromboses and Hemostasis)].
Averkov, OV, 2004
)
0.32
" In vivo studies in rats with ardeparin (1,200 IU/kg) and sodium caprate (100 mg/kg) led to a relative bioavailability of 27% with plasma anti-factor Xa levels within the therapeutic range (>0."( Oral delivery of low-molecular-weight heparin using sodium caprate as absorption enhancer reaches therapeutic levels.
Motlekar, NA; Srivenugopal, KS; Wachtel, MS; Youan, BB, 2005
)
0.33
" The oral bioavailability of ardeparin formulated with L-arginine (250 mg kg(-1)) was increased by approximately 2 fold compared with control."( Modulation of gastrointestinal permeability of low-molecular-weight heparin by L-arginine: in-vivo and in-vitro evaluation.
Motlekar, NA; Srivenugopal, KS; Wachtel, MS; Youan, BB, 2006
)
0.33
" In the presence of 100 microg/kg of AT1002, ardeparin oral bioavailability was significantly increased (F(relative/s."( Zonula occludens toxin synthetic peptide derivative AT1002 enhances in vitro and in vivo intestinal absorption of low molecular weight heparin.
Fasano, A; Motlekar, NA; Wachtel, MS; Youan, BB, 2006
)
0.33
" The efficacy of PEI in enhancing the bioavailability of nasally administered LMWH can be ranked as PEI-1000 kDa>or=PEI-750 kDa>PEI-25 kDa."( Positively charged polyethylenimines enhance nasal absorption of the negatively charged drug, low molecular weight heparin.
Ahsan, F; Bai, S; Harashima, H; Hussain, A; Khalil, IA; Yang, T, 2006
)
0.33
" Positively charged dendrimers increased the relative bioavailability of enoxaparin by 40%, while a negatively charged dendrimer had no effect."( Dendrimers as a carrier for pulmonary delivery of enoxaparin, a low-molecular weight heparin.
Ahsan, F; Bai, S; Thomas, C, 2007
)
0.34
"0625% PLA of molecular weight 93 kDa led to a twofold increase in the relative bioavailability of LMWH compared to the control (enoxaparin plus normal saline)."( Complexation of a poly-L-arginine with low molecular weight heparin enhances pulmonary absorption of the drug.
Ahsan, F; Hussain, A; Rawat, A; Yang, T, 2008
)
0.35
"Since low molecular weight heparin has greater bioavailability and sustained serum levels in vivo than unfractionated heparin, it has been used to supplant unfractionated heparin to achieve therapeutic anticoagulation in humans."( Enoxaparin does not ameliorate limb ischemia-reperfusion injury.
Abbruzzese, TA; Albadawi, H; Kang, J; Lamuraglia, GM; Patel, VI; Watkins, MT; Yoo, JH, 2008
)
0.35
"Myeloperoxidase (MPO), a leukocyte-derived heme enzyme binds to the endothelium and depletes vascular nitric oxide (NO) bioavailability in animal models."( Liberation of vessel adherent myeloperoxidase by enoxaparin improves endothelial function.
Baldus, S; Heitzer, T; Klinke, A; Lau, D; Meinertz, T; Rudolph, TK; Rudolph, V; Szoecs, K; Witte, A, 2010
)
0.36
" Evidence suggests inconsistent bioavailability in intensive care unit (ICU) patients."( Thrombelastography versus AntiFactor Xa levels in the assessment of prophylactic-dose enoxaparin in critically ill patients.
Cho, SD; Morris, MS; Schreiber, MA; Underwood, SJ; Van, PY; Watters, JM, 2009
)
0.35
" In conclusion, the oral bioavailability of enoxaparin can be enhanced by improving the bioadhesive properties of PEC via the chemical modification of chitosan employed."( Bioadhesion and oral absorption of enoxaparin nanocomplexes.
Junyaprasert, VB; Mao, S; Na, L; Sun, W; Wang, J; Wang, Y; Zhang, T, 2010
)
0.36
" The bioavailability after SC injection was approximately 100%."( Pharmacokinetics of the low molecular weight heparin dalteparin in cats.
Böhm, C; Kietzmann, M; Mischke, R; Schmitt, J; Wolf, P; Wolken, S, 2012
)
0.63
" There is variable bioavailability of LMWH with standard therapy."( The effects of location and low-molecular-weight heparin administration on deep vein thrombosis outcomes in trauma patients.
Alonzo, BJ; Differding, J; Hamilton, G; Kremenevskiy, I; Lee, TH; McNamara, S; Schreiber, MA; Underwood, SJ, 2013
)
0.39
" In conclusion, oral bioavailability of enoxaparin can be enhanced by structure modification of the carriers and the bioavailability is hydrophobic modification degree dependent."( Exploration of hydrophobic modification degree of chitosan-based nanocomplexes on the oral delivery of enoxaparin.
Junyaprasert, VB; Li, C; Li, L; Li, Y; Mao, S; Sun, Y; Tian, Y; Wang, L, 2013
)
0.39
"05) the oral bioavailability of enoxaparin in comparison to plain enoxaparin solution as revealed by threefold increase in AUC of plasma drug concentration time curve and around 60% reduction in thrombus formation in rat venous thrombosis model."( Alginate coated chitosan core shell nanoparticles for oral delivery of enoxaparin: in vitro and in vivo assessment.
Bagre, AP; Jain, K; Jain, NK, 2013
)
0.39
" However, evidence suggests decreased bioavailability of enoxaparin in critically ill patients."( Prospective Evaluation of Weight-Based Prophylactic Enoxaparin Dosing in Critically Ill Trauma Patients: Adequacy of AntiXa Levels Is Improved.
Becher, RD; Borgerding, EM; Farrah, JP; Kilgo, P; Lauer, C; Miller, PR; Nunez, JM; Rebo, GJ; Stirparo, JJ, 2015
)
0.42
" Areas covered: We have not found noticeable differences between Brazilian biosimilar enoxaparins and the original product regarding their physicochemical properties, disaccharide composition, anticoagulant activity, bioavailability and safety."( Update on Brazilian biosimilar enoxaparins.
Glauser, BF; Mourão, PA; Oliveira, SM; Tovar, AM; Vilanova, E, 2016
)
0.43
" However, it is poorly absorbed in the gastrointestinal tract."( Synthesis of Eudragit® L100-coated chitosan-based nanoparticles for oral enoxaparin delivery.
Arruda, IES; Chaves, LL; da Silva, DA; de Jesus Oliveira, AC; de La Roca Soares, MF; de Lemos Vasconcelos Silva, E; de Oliveira Silva Ribeiro, F; de Oliveira, TC; Patriota, YBG; Soares-Sobrinho, JL, 2021
)
0.62
" The inability of PED to adequately protect major circulating blood cells is probably due to enhanced clearance or/and diminished bioavailability of enoxaparin during COVID."( Enoxaparin dose impacts blood cell phenotypes during mild SARS-CoV-2 infection: the observational single-center study.
Buryachkovskaya, L; Docenko, J; Ermishkin, V; Lomakin, N; Melkumyants, A; Serebruany, V, 2021
)
0.62
"7-280) and relative bioavailability of 40."( Low and Highly Variable Exposure to Prophylactic LMWH Nadroparin in Critically Ill Patients: Back to the Drawing Board for Prophylactic Dosing?
Diepstraten, J; Kruip, MJHA; Ter Heine, R; van der Heiden, PLJ; van Rongen, A; Zijlstra, MP, 2023
)
0.91

Dosage Studied

Dalteparin achieved targeted anti-factor Xa levels in 18 children and young adults with acute VTE with a standardized age-based dosing regimen. Once-daily dosing of prophylactic LMWH daltepin is feasible, safe, and effective in high-risk trauma patients.

ExcerptRelevanceReference
" In Group 3 the dosage of Parnaparin resulted in a significant prolongation of the APTT and in lower FpA levels."( Effects of two dosages of subcutaneous low molecular weight heparin (Parnaparin) and of unfractionated heparin on fibrin formation and lipolysis in acute myocardial infarction.
Branzi, A; Cervi, V; Magnani, B; Melandri, G; Semprini, F, 1992
)
0.28
" Regardless of the dosage designation (mg/kg or units/kg) each LMWH followed a distinct TFPI release profile."( The role of tissue factor pathway inhibitor in the mediation of the antithrombotic actions of heparin and low-molecular-weight heparin.
Bermes, EW; Fareed, J; Hoppensteadt, DA; Jeske, W, 1995
)
0.29
" However, the ratio between the dosage producing these effects is quite large."( Pharmacologic validation of the clinical effects of an optimized low-molecular-weight heparin-reviparin.
Ahsan, A; Eschenfelder, V; Fareed, J; Hoppensteadt, D; Iqbal, O; Jeske, W, 1995
)
0.29
" This profound increase in TFPI antigen levels was dependent on the dosage of Ardeparin administered."( TFPI antigen levels in normal human volunteers after intravenous and subcutaneous administration of unfractionated heparin and a low molecular weight heparin.
Fareed, J; Fasanella, A; Hoppensteadt, DA; Jeske, W; Walenga, JM, 1995
)
0.29
" The target antithrombotic aXa levels, determined by amidolytic assay in plasma 6 hours after each ardeparin injection, were most optimally attained and maintained by twice-daily dosing based on body weight and correlated well with incremental increases in Heptest values measured chronometrically."( Monitoring the anticoagulant effects of a low molecular weight heparin preparation. Correlation of assays in orthopedic surgery patients receiving ardeparin sodium for prophylaxis of deep venous thrombosis.
Davidson, BL; Druy, E; Esparraguera, IM; Fortune, WP; Giordano, J; Holloway, DS; Jacobs, HM; Kessler, CM, 1995
)
0.29
" In comparative clinical trials, this dosage demonstrated either improved efficacy and a similar haemorrhagic profile, or a similar degree of efficacy with a lower rate of haemorrhagic events, compared with unfractionated heparin 5000IU 3 times daily."( Enoxaparin. A reappraisal of its pharmacology and clinical applications in the prevention and treatment of thromboembolic disease.
Goa, KL; Noble, S; Peters, DH, 1995
)
0.29
"Hemodialysis was performed on dogs, following intravenous bolus injections of LHG at dosage levels of 50, 100 and 200 IU/kg and heparin at the levels of 100 and 200 IU/kg."( [Anticoagulant effect of a single bolus injection of parnaparin sodium (LHG) on a hemodialysis model in dogs].
Akizawa, T; Kanamori, N; Katai, T; Kinugasa, E; Kodama, T; Koshikawa, S; Ohtawa, M; Okitsu, M; Sugiyama, T, 1994
)
0.29
"In order to define the optimal dosage of a low molecular weight enoxaparine (Lovenox) in the prevention of clotting in extracorporeal circulation during hemodialysis, a multicentre trial was conducted in 72 patients dialysed in seven hemodialysis units."( [Optimization of enoxaparin dose in the prevention of coagulation in the circuits of hemodialysis: results of a multicenter study].
Combe, S; de Groc, F; Debure, A; Dupuy, CA; Fievet, P; Küntziger, H; Reach, I; Teboulle, D; Thébaud, HE; Thoumazou, G, 1994
)
0.29
" In the liver, the concentrations were almost constant during a dosing interval."( Pharmacokinetics of tinzaparin (Logiparin)--a low molecular weight heparin--after single and repeated intravenous administration in rats.
Johansen, PB; Ostergaard, PB; Rasmussen, SN, 1994
)
0.29
" Thirty-three pigs received bolus injections of 300 IU/kg with or without additional dosage during CPB and with or without subsequent protamine sulphate."( Low-molecular-weight heparin (Fragmin) versus heparin for anticoagulation during cardiopulmonary bypass in open heart surgery, using a pig model.
Bagge, L; Holmer, E; Malm, T; Nyström, SO; Tydén, H; Wahlberg, T, 1994
)
0.29
" The standard dosage of heparin (1,500 IU, n = 6) was compared with a lower dosage (1,000 IU, n = 3) and several dosages of Fragmin (IU anti-FXa): 750 (n = 1), 1,500 (n = 3), 2,100 (n = 4) and 2,500 (n = 3)."( Fragmin (LMWH) vs heparin for anticoagulation during in vitro recycling of human blood in cardiopulmonary bypass circuits: dose-dependence and mechanisms of clotting.
Bagge, L; Holmer, E; Nyström, SO; Tydén, H; Wahlberg, T, 1994
)
0.29
"Four trials of enoxaparin (involving 567 patients) and six trials of warfarin (involving 630) met the following criteria: randomized controlled trial, prophylaxis started no later than 24 hours after surgery and continued for at least 7 days, warfarin dose monitored and adjusted appropriately, enoxaparin dosage 30 mg twice daily, and DVT confirmed by bilateral venography."( Cost-effectiveness of enoxaparin versus warfarin prophylaxis against deep-vein thrombosis after total hip replacement.
Anderson, DR; Goeree, R; O'Brien, BJ, 1994
)
0.29
" There was not a clear dose-response curve with LMWHs."( Effects of low molecular weight heparins on fibrin polymerization and clot sensitivity to t-PA-induced lysis.
Agnelli, G; Ascani, A; Morini, M; Nenci, GG; Parise, P, 1993
)
0.29
" These results are similar to those obtained with the same dosage in other clinical settings."( Pharmacokinetic study of the low-molecular-weight heparin fraxiparin in patients with nephrotic syndrome.
Aiach, M; Alhenc-Gelas, M; Jacquot, C; Rossert, J, 1995
)
0.29
" Studies have shown that weight-based dosing influences significantly both the time to reach a therapeutic intensity of anticoagulation and the incidence of thromboembolic recurrence."( Contemporary use of and future roles for heparin in antithrombotic therapy.
Gibaldi, M; Wittkowsky, AK, 1995
)
0.29
" Fourteen children had a deep vein thrombosis or pulmonary embolism, nine had thrombotic complications in the central nervous system, and two had complex congenital heart disease, for which they received prophylaxis at a lower dosage (0."( Low-molecular-weight heparin in pediatric patients with thrombotic disease: a dose finding study.
Adams, M; Andrew, M; Brooker, LA; Marzinotto, V; Massicotte, P, 1996
)
0.29
" According to our experience, Fragmin at the dosage used proved to be both effective and safe in these patients."( Upper extremity deep venous thrombosis in cancer patients with venous access devices--prophylaxis with a low molecular weight heparin (Fragmin).
Abad, A; Alastrue, A; Mira, X; Monreal, M; Muxart, J; Rosell, R; Rull, M, 1996
)
0.29
" Further clinical trials are required to test different dosage regimens as a thromboprophylactic agent in high risk patients."( Patients at risk of venous thromboembolism--clinical results with reviparin.
Cohen, AT; Kakkar, VV; Mohamed, MS, 1996
)
0.29
" A uniform dosage of 2 mg/kg/day in two divided doses was administered subcutaneously for 10 days during hospitalization and then continued on an out-patient basis."( Low molecular heparin (Enoxaparin) as an alternative treatment of acute deep venous thrombosis in gynecologic oncology patients.
Altaras, M; Aviram, R; Beyth, Y; Fishman, A; Klein, Z, 1996
)
0.29
" The mean time for dosage increase was 20."( Thromboprophylaxis with low molecular weight heparin (Fragmin) in high risk pregnancies.
Buchanan, N; Copplestone, A; Doughty, HA; Hughes, G; Hunt, BJ; Kerslake, S; Khamashta, M; Majumdar, G, 1997
)
0.3
" The dosage and duration of the treatment have been the usual ones."( [The role of clivarin in the preventive therapy of thromboembolism].
Angelescu, N; Boacă, R; Burcoş, T; Greere, M; Jianu, E; Jitea, N; Leoveanu, A; Mircea, N,
)
0.13
" Since PTT did not reach 40 seconds, Na-heparin dosage was increased to 3 x 7500 IE."( [Comparison between low-molecular and unfractionated heparin in the prevention of thrombosis in patients with total endoprosthetic replacement of hip and knee joint].
Eulert, J; Gohlke, F; König, A; Kramer, C; Rader, CP,
)
0.13
"A French multicentre, open, randomized trial was conducted in lung cancer surgery in order to test the optimal dosage regimen: Fraxiparine 3075 IU AXa (fixed dosage) and Fraxiparine 4100 or 6150 IU AXa (dosage adjusted for body weight only), over a period of 8 days."( [Efficacy and tolerability of fraxiparine in the prevention of thromboembolic complications in oncologic thoracic surgery].
Azorin, JF; Dahan, M; Pansart, M; Regnard, JF,
)
0.13
"The aim of this trial, undertaken with the participation of 13 centres, was to establish the minimal effective dosage of nadroparin (Fraxiparin) for the prevention of left ventricular mural thrombosis in acute anterior myocardial infarction which was not treated by thrombolysis."( [Fraxiparin and prevention of left ventricular thrombosis in non-thrombolyzed myocardial infarction. FRATIV Study].
Charbonnier, B, 1997
)
0.3
" The objective of the study was to evaluate the effectiveness, safety and dosage of low-molecular heparin nandroparinum calcium--Fraxiparine (Sanofi) in haemodialyzation treatment of adult patients."( [Use of the low-molecular heparin, Fraxiparine, during hemodialysis].
Monhart, V; Petrů, K, 1998
)
0.3
" As the PTT did not reach 40 seconds, the heparin sodium dosage was increased to 7,500 IU 3 times daily."( Low-molecular-weight heparin and partial thromboplastin time-adjusted unfractionated heparin in thromboprophylaxis after total knee and total hip arthroplasty.
Eulert, J; Hendrich, C; König, A; Kramer, C; Rader, CP, 1998
)
0.3
" Low-molecular-weight heparin provides more reliable anticoagulation and less need for patient monitoring and dosage adjustment than standard unfractionated heparin (UFH) and therefore is well suited for long-term anticoagulation on an outpatient basis."( TIMI 11B. Enoxaparin versus unfractionated heparin for unstable angina or non-Q-wave myocardial infarction: a double-blind, placebo-controlled, parallel-group, multicenter trial. Rationale, study design, and methods. Thrombolysis in Myocardial Infarction
Antman, EM, 1998
)
0.3
" TIMI 11 A was designed to compare the safety and tolerability of two dosage regimens of enoxaparin in patients with unstable angina or non-Q wave MI, whereas TIMI 11B was designed as a phase III trial, comparing the efficacy and safety of enoxaparin with those of UFH in the acute phase, and the efficacy and safety of extended administration of LMWH with those of placebo for 45 days."( Management of acute coronary syndromes with low molecular weight heparin: TIMI 11A and 11B.
Turpie, AG, 1998
)
0.3
" Danaparoid, a low-molecular-weight heparinoid, and once-daily enoxaparin are recently released dosage forms that have been evaluated as pharmacoprophylaxis for DVT after hip replacement surgery."( Cost effectiveness of danaparoid compared with enoxaparin as deep vein thrombosis prophylaxis after hip replacement surgery.
Wade, WE, 1999
)
0.3
" LMWH allows for consistent dosing in postoperative patients without the need for laboratory monitoring."( Intrahepatic hemorrhage after use of low-molecular-weight heparin for total hip arthroplasty.
Houde, JP; Steinberg, G, 1999
)
0.3
" This study was designed to test the hypothesis that 3 months of subcutaneous dosing of ardeparin would reduce angiographic restenosis after coronary balloon angioplasty."( Usefulness of subcutaneous low molecular weight heparin (ardeparin) for reduction of restenosis after percutaneous transluminal coronary angioplasty.
Gimple, LW; Herrmann, HC; Mammen, E; Winniford, M, 1999
)
0.3
" Patient and operative characteristics, hematologic values, and timing of enoxaparin dosing were analyzed as related to major and minor bleeding complications."( Bleeding complications with enoxaparin for deep venous thrombosis prophylaxis.
Atkinson, RE; Shaieb, MD; Watson, BN, 1999
)
0.3
" However, there are few studies on the appropriate dosage of LMW heparins in haemodialysis."( A single dose of dalteparin effectively prevents clotting during haemodialysis.
Bjørnsen, S; Brosstad, F; Fauchald, P; Hartmann, A; Sagedal, S; Sundstrøm, K, 1999
)
0.64
" We conclude that one daily subcutaneous injection of calcium nadroparin in a fixed, weight-adjusted dosage scheme is superior to intermittent pneumatic compression of the foot for thromboprophylaxis after TKA."( Prevention of deep-vein thrombosis after total knee replacement. Randomised comparison between a low-molecular-weight heparin (nadroparin) and mechanical prophylaxis with a foot-pump system.
Blanchard, J; Bounameaux, H; Didier, D; Hoffmeyer, P; Leyvraz, PF; Meuwly, JY; Miron, MJ; Schneider, PA, 1999
)
0.3
" Dose-response curves to heparin and enoxaparin were generated."( Heparin-induced vasodilation in human hand veins.
Abiose, AK; Blaschke, TF; Chalon, S; Hoffman, BB; Moreno, HJ; Tangphao, O, 1999
)
0.3
" This finding has significant implications for appropriate dosing of enoxaparin in pregnancy."( Changes in the pharmacokinetics of the low-molecular-weight heparin enoxaparin sodium during pregnancy.
Casele, HL; Laifer, SA; Venkataramanan, R; Woelkers, DA, 1999
)
0.3
" However, close scrutiny of the methodology of the clinical trials in UCAD reveals considerable differences in study designs, dosage regimens, duration of administration of active treatments, and the timing and definition of endpoints."( Can we differentiate the low-molecular-weight heparins?
Turpie, AG, 2000
)
0.31
" Patients are frequently treated with long-term low-molecular weight heparin despite a lack of evidence for its effectiveness, and in the absence of validated dosing recommendations."( Pharmacokinetic profile of a low-molecular weight heparin (reviparin) in pregnant patients. A prospective cohort study.
Crowther, MA; Crowther, R; Ginsberg, J; Johnston, M; Julian, J; Laskin, C; Spitzer, K, 2000
)
0.31
" Therefore, tinzaparin administered in a dosage of 75 U anti-Xa/kg BW 12 hours before surgery is significantly more protective against proximal DVT and safer than the standard regimen of 50 U anti-Xa/kg BW started 2 hours before surgery in patients undergoing primary elective hip arthroplasty."( Dose relation in the prevention of proximal vein thrombosis with a low molecular weight heparin (tinzaparin) in elective hip arthroplasty.
Andersen, BS; Borris, LC; Ejstrud, P; Jensen, HP; Lassen, MR; Poulsen, KA, 2000
)
0.31
" Enoxaparin does not activate platelets, has a more predictable dose response that facilitates weight-adjusted dosing and may have enhanced antithrombotic (increased anti-Xa activity) and safety (reduced anti-IIa activity) properties when compared with unfractionated heparin."( Combination enoxaparin and abciximab therapy during percutaneous coronary intervention: "NICE guys finish first".
Barr, L; Broderick, T; Brodie, B; Casale, P; Christy, G; Cohen, M; Fry, E; Kereiakes, DJ; Lengerich, R; Matthai, W; Moliterno, D; Niederman, A; Shimshak, T; Zidar, J, 2000
)
0.31
"The effects of dose and dosing time on the anticoagulant activity of a low molecular weight heparin (Fraxiparine) were studied in rats."( Establishing the dose-dependent daily variations of a low molecular weight heparin (Fraxiparine) through a population approach analysis in the rat.
Abrial, D; Blanc, A; Bouchut, C; Buisson, B; Decousus, H; Laporte-Simitsidis, S; Mismetti, P; Réhailia, M, 2000
)
0.31
" Each dosage was examined in 5 adult Beagles."( [Phamacokinetics of low-molecular-weight heparins Fragmin D in dogs].
Grebe, S; Jacobs, C; Kietzmann, M; Mischke, R, 2000
)
0.31
" They are more predictable in action, do not require frequent activated partial thromboplastin time (aPTT) measurements and dosage adjustments, are easier to administer, and are potentially more efficacious."( Role of low-molecular-weight heparins in the management of patients with unstable angina pectoris and non-Q-wave acute myocardial infarction.
Monrad, ES, 2000
)
0.31
" However, body weight-adjusted dosage of low-molecular-weight heparin may be cumbersome and could lead possibly to incorrect dosing."( Fixed-dose, body weight-independent subcutaneous LMW heparin versus adjusted dose unfractionated intravenous heparin in the initial treatment of proximal venous thrombosis. EASTERN Investigators.
Büller, HR; Harenberg, J; Huisman, MV; Koppenhagen, K; Schmidt, JA; Tolle, A, 2000
)
0.31
" Dosage was 40 mg/day in women with solitary defect and 80 mg/day in combined defects."( Gestational outcome in thrombophilic women with recurrent pregnancy loss treated by enoxaparin.
Blumenfeld, Z; Brenner, B; Hoffman, R; Weiner, Z; Younis, JS, 2000
)
0.31
" Anti-Xa levels were elevated at 15 minutes after dosing in the OHEP/SNAC group and remained significantly elevated at 4 hours (P<0."( Orally administered unfractionated heparin with carrier agent is therapeutic for deep venous thrombosis.
Baughman, RA; Gonze, MD; Leone-Bay, A; Money, SR; Salartash, K; Sternbergh, WC, 2000
)
0.31
" Incremental cost-effectiveness ratio calculations demonstrate that warfarin dosed to an international normalized ratio of 2-2."( Cost effectiveness of deep venous thrombosis prophylaxis after hip fracture.
Chisholm, MA; Wade, WE, 2000
)
0.31
" Prospective studies need to be conducted to define the drug's role and dosage adjustments in these patients."( Enoxaparin and bleeding complications: a review in patients with and without renal insufficiency.
Barnes, JF; Gerlach, AT; Pickworth, KK; Seth, SK; Tanna, SB, 2000
)
0.31
" Doses of 5, 10, and 20 microg/ml abciximab prolonged the lag phase until the onset of platelet aggregation, but this effect was independent of the dosage used."( Effects of the glycoprotein IIb/IIIa receptor antagonist c7E3 Fab and anticoagulants on platelet aggregation and thrombin potential under high coagulant challenge in vitro.
Cvirn, G; Gallistl, S; Koestenberger, M; Muntean, W; Roschitz, B, 2000
)
0.31
"To investigate whether there were significant differences in the volume of distribution (V) and clearance (CL) of dalteparin in obese versus normal-weight patients, and thereby determine whether dosing of dalteparin should be based on total body weight, lean body weight or an adjusted body weight in obese patients."( The effect of body weight on dalteparin pharmacokinetics. A preliminary study.
Duffull, SB; Yee, JY, 2000
)
0.81
"Anti-Xa activity levels were used to assess prophylactic (33 women) and therapeutic (15 women) dalteparin dosage throughout pregnancy."( Prophylaxis and treatment of thromboembolic diseases during pregnancy with dalteparin.
Rey, E; Rivard, GE, 2000
)
0.76
"Enoxaparin 1 mg/kg intravenously every eight hours was used safely in this preterm infant with suspected thrombosis, suggesting that more than one dosing regimen may be appropriate in this population."( Use of enoxaparin in a preterm infant.
Dunaway, KK; Gal, P; Ransom, JL, 2000
)
0.31
" Following is an overview of major insights from the prophylaxis in Medical patients with Enoxaparin (MEDENOX) trial, which was undertaken to evaluate the efficacy of 2 dosage regimens of the low-molecular-weight heparin enoxaparin for prevention of venous thromboembolism in acutely ill medical patients."( Thrombosis prophylaxis in the acutely ill medical patient: insights from the prophylaxis in MEDical patients with ENOXaparin (MEDENOX) trial.
Turpie, AG, 2000
)
0.31
" In early trials, such as FRISC (Fragmin during instability in coronary artery disease) and FRIC (Fragmin in unstable coronary artery disease), the results of extended treatment were inconclusive; however, the trial populations included patients of relatively low risk and used a once-daily dosing regimen."( Acute and prolonged treatment with low-molecular-weight heparin therapy in patients with unstable coronary artery disease.
Husted, S; Kher, A, 2000
)
0.31
"To evaluate the pharmacokinetics of enoxaparin in end-stage renal disease (ESRD), and determine if dosage reduction is necessary to maintain antifactor Xa activity concentrations within the therapeutic range."( The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease.
Brophy, DF; Comstock, TJ; Gehr, TW; Venitz, J; Wazny, LD, 2001
)
0.31
"6 was estimated for a dosing interval of every 12 hours based on single-dose pharmacokinetics."( The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease.
Brophy, DF; Comstock, TJ; Gehr, TW; Venitz, J; Wazny, LD, 2001
)
0.31
"Based on antifactor Xa activity, ESRD has little effect on the pharmacokinetics of enoxaparin, and dosing adjustments are unnecessary."( The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease.
Brophy, DF; Comstock, TJ; Gehr, TW; Venitz, J; Wazny, LD, 2001
)
0.31
"Low-molecular-weight heparins are frequently used to treat venous thromboembolism, but optimal dosing regimens and clinical outcomes need further definition."( Effects of a low-molecular-weight heparin on thrombus regression and recurrent thromboembolism in patients with deep-vein thrombosis.
Breddin, HK; Hach-Wunderle, V; Kakkar, VV; Nakov, R, 2001
)
0.31
" There was no correlation between anti-Xa or anti-IIa AUC or A(max) and bodyweight in the present study supporting the weight-adjusted dosing regimen."( Anticoagulant pharmacodynamics of tinzaparin following 175 iu/kg subcutaneous administration to healthy volunteers.
Barrett, JS; Gaskill, JL; Hainer, JW; Hua, TA; Johansen, K; Knebel, W; Kornhauser, DM; Pieniaszek, HJ; Sprogel, P; van Lier, JJ, 2001
)
0.31
"The effects of dosing time on the anticoagulant activity of unfractionated heparin, low molecular weight heparin (nadroparin) and danaproid were investigated."( A chronopharmacodynamic study on standard heparin, a low molecular weight heparin (nadroparin) and danaproid: establishing and comparing the daily variations of these drugs in rats.
Abrial, D; Blanc, A; Bouchut, C; Buisson, B; Decousus, H; Laporte-Simitsidis, S; Mismetti, P; Réhailia, M,
)
0.13
" One daily dosage of 5,000 IU anti-Xa resulted in a measurable level of FXa for 24 h in pregnancy week 40, compared with 17h at pregnancy week 37."( Accumulation of low molecular mass heparin during prophylactic treatment in pregnancy.
Blombäck, M; Bremme, K; van Rooijen, M; Yu, A, 2001
)
0.31
" This study evaluates the dose-response relationship using a selectin receptor antagonist."( P-selectin antagonism causes dose-dependent venous thrombosis inhibition.
Chapman, AM; Fex, BA; Greenfield, LJ; Londy, FJ; Myers, DD; Schaub, R; Wakefield, TW; Wrobleski, SK, 2001
)
0.31
"Currently, prospective clinical trials investigate the efficacy of combined use of LMWH with thrombolytics, GPIIb/IIIa blockers and the optimal dosage of LMWH during coronary interventions."( [Low molecular weight heparins in acute coronary syndrome].
Huber, K; Niessner, A; Niessner, H, 2001
)
0.31
" The pharmacokinetic and pharmacodynamic differences among LMWHs can be explained by comparing methods of preparation, molecular structures, half-lives, antithrombin- and non-antithrombin-mediated actions, effect on thrombus, and dosing interval."( Differentiation of the low-molecular-weight heparins.
Racine, E, 2001
)
0.31
" Future issues that need to be addressed include refinement of indications for administration and patient selection, comparison between existing agents, evaluation of newer agents, and optimization of dosing to maximize benefit and safety in the use of these powerful new classes of drugs."( Glycoprotein IIb/IIIa antagonists and low-molecular weight heparin in acute coronary syndromes.
Vernon, SM, 2001
)
0.31
"Data evaluating the safety of using weight-based dosing of low-molecular-weight heparin (LMWH) in obese patients are limited."( Effect of patient weight on the anticoagulant response to adjusted therapeutic dosage of low-molecular- weight heparin for the treatment of venous thromboembolism.
Anderson, DR; Burton, E; Wilbur, K; Wilson, SJ,
)
0.13
" As prophylaxis, reviparin 1,750 anti-XaIU once daily was as effective as unfractionated heparin 5,000IU twice daily in 1,311 patients undergoing abdominal surgery and, in a once daily dosage of 4,200 anti-XaIU, was as effective as subcutaneous enoxaparin sodium 40 mg/day or acenocoumarol in patients undergoing hip replacement surgery."( Reviparin: a review of its efficacy in the prevention and treatment of venous thromboembolism.
Jarvis, B; McClellan, K; Wellington, K, 2001
)
0.31
" The second issue is whether early use of an aggressively dosed statin is superior to a current trial-based "accepted care" regimen of a lower-dose statin started 3 to 6 months after an acute event."( The A-to-Z Trial: Methods and rationale for a single trial investigating combined use of low-molecular-weight heparin with the glycoprotein IIb/IIIa inhibitor tirofiban and defining the efficacy of early aggressive simvastatin therapy.
Bilheimer, D; Blazing, MA; Braunwald, E; Califf, RM; De Lemos, JA; Dyke, CK, 2001
)
0.31
"Little information is available concerning dosage and optimal initiation of thromboprophylactic therapy with low-molecular-weight heparin (enoxaparin) in nonelective hip surgery."( Thromboprophylaxis with 60 mg enoxaparin is safe in hip trauma surgery.
Greiner, N; Korninger, C; Roller, RE; Sim, E; Thaler, HW, 2001
)
0.31
" The dose-response curve had a bell-shaped configuration: enoxaparin, 80 microg/kg, and unfractionated heparin, 200 U/kg, were the optimal doses."( Heparin and low-molecular-weight heparin (enoxaparin) significantly ameliorate experimental colitis in rats.
Brazowski, E; Dotan, I; Halpern, Z; Hershkoviz, R; Karmeli, F; Peled, Y; Rachmilewitz, D, 2001
)
0.31
"The dosage of the subcutaneous low molecular weight heparin enoxaparin in unstable angina patients undergoing coronary angiogram and coronary angioplasty depends clearly on the renal function."( Enoxaparin in unstable angina patients with renal failure.
Ankri, A; Choussat, R; Collet, JP; Lison, L; Montalescot, G, 2001
)
0.31
" Body weight was not a significant covariate in the model supporting the observations in earlier well-defined trials, where tinzaparin was dosed on a weight basis (lU/kg)."( Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis.
Barrett, JS; Gastonguay, M; Gibiansky, E; Hainer, JW; Hua, TA; Hull, RD; Pentikis, H; Planès, A, 2001
)
0.31
" Hence, to suppress thrombin generation, apparently, the dosage of LMW heparin should be adjusted to the gestational age rather than using fixed doses throughout the pregnancy."( Evaluation of an optimal dose of low-molecular-weight heparin for thromboprophylaxis in pregnant women at risk of thrombosis using coagulation activation markers.
Bombeli, T; Fehr, J; Raddatz Mueller, P,
)
0.13
" All patients received enoxaparin at a dosage of 100 IU antiXa/kg twice daily before undergoing multiplane TEE."( A new therapeutic strategy for electrical cardioversion of atrial fibrillation.
de Luca, I; de Luca, L; Del Salvatore, B; Sorino, M, 2001
)
0.31
" In morbidity obese patients, the limited number of comparative trials are too sparse to allow a consensus on the effective dose and dosing schedule."( Prophylaxis of venous thromboembolism using two different doses of low-molecular-weight heparin (nadroparin) in bariatric surgery: a prospective randomized trial.
Dimitrakopoulos, A; Kalfarentzos, F; Karamesini, M; Kehagias, I; Maniati, A; Stavropoulou, F; Yarmenitis, S, 2001
)
0.31
" The study did not evaluate a dose-response for efficacy, and no differences between the three dose levels of melagatran and ximelagatran were shown."( A dose-ranging study of the oral direct thrombin inhibitor, ximelagatran, and its subcutaneous form, melagatran, compared with dalteparin in the prophylaxis of thromboembolism after hip or knee replacement: METHRO I. MElagatran for THRombin inhibition in
Arfwidsson, AC; Bylock, A; Eriksson, BI; Eriksson, UG; Fager, G; Frison, L; Gustafsson, D; Kälebo, P, 2002
)
0.52
" All patients received a multi-modality DVT prophylaxis protocol that included: early ambulation, graduated compression stockings, intermittent pneumatic compression, and enoxaparin (LMWH) in two dosage groups."( A comparison of two different prophylactic dose regimens of low molecular weight heparin in bariatric surgery.
Hoedema, RM; Scholten, DJ; Scholten, SE, 2002
)
0.31
" Dosage adjustments were made by increments or decrements of 500 IU."( Comparison between tinzaparin and standard heparin for chronic hemodialysis in a Canadian center.
Dumont, M; Jean, N; Kassis, J; Leblanc, M; Lord, H,
)
0.13
" Thus, with the present dosing regimens, fondaparinux is probably preferable to enoxaparin for the prevention of venous thromboembolism."( Fondaparinux versus enoxaparin for the prevention of venous thromboembolism.
Doggrell, SA, 2002
)
0.31
"5 mg/kg intravenous (IV), and eptifibatide using the ESPIRIT dosing (180 g/kg bolus IV, immediately followed by a 2 g/kg/minute continuous IV infusion, and then a second 180 g/kg bolus IV ten minutes after the first bolus)."( Use of clopidogrel loading, enoxaparin, and double-bolus eptifibatide in the setting of early percutaneous coronary intervention for acute coronary syndromes.
Bertolet, BD; Gupta, A; Miller, L, 2002
)
0.31
"This pharmacodynamic study examined weight-based dosing of the low molecular weight heparin (LMWH), tinzaparin, in heavyweight/obese subjects."( Dosing in heavy-weight/obese patients with the LMWH, tinzaparin: a pharmacodynamic study.
Assaid, CA; Barrett, JS; Cox, DS; Fossler, MJ; Hainer, JW; Leathers, T; Leese, PT, 2002
)
0.31
" The practice of twice-daily LMWH dosing in North America might, in part, account for the greater number of epidural hematomas reports compared to Europe where once-daily LMWH is used."( Anticoagulant effect at the time of epidural catheter removal in patients receiving twice-daily or once-daily low-molecular-weight heparin and continuous epidural analgesia after orthopedic surgery.
Crowther, MA; Douketis, JD; Kinnon, K, 2002
)
0.31
"The chemistry, pharmacokinetics, pharmacodynamics, clinical efficacy, dosage and administration, adverse effects, and therapeutic role of tinzaparin are reviewed."( Tinzaparin sodium: a low-molecular-weight heparin.
Carlson, SS; Lenhart, SE; Neely, JL, 2002
)
0.31
"Patients with acute deep vein thrombosis (DVT) were treated with a body-weight independent dosage of 2 x 8000 aXa IU low-molecular-weight heparin (LMWH) Certoparin."( Fixed-dose versus adjusted-dose low molecular weight heparin for the initial treatment of patients with deep venous thrombosis.
Harenberg, J, 2002
)
0.31
" SC weight-based dosing on off-dialysis days is a feasible regimen for further clinical thromboprophylaxis efficacy studies in hemodialysis patients."( Intravenous and subcutaneous weight-based dosing of the low molecular weight heparin tinzaparin (Innohep) in end-stage renal disease patients undergoing chronic hemodialysis.
Assaid, CA; Barrett, JS; Cox, DS; Fossler, MJ; Hainer, JW; Hua, TA; Pittenger, AL; Sherrard, DJ; Stephenson, CA; Swan, SK; Williams, RM, 2002
)
0.31
" The treatment protocols for low molecular weight heparin and warfarin, using dosing protocols determined by weight and INR results, are described."( Outpatient treatment of community acquired venous thromboembolism--the Christchurch experience.
Han, DY; Heaton, D; Inder, A, 2002
)
0.31
" We did a multicentre, randomised, double-blind study to examine the dose-response relation of subcutaneous melagatran, a direct thrombin inhibitor, followed by oral ximelagatran as thromboprophylaxis after total hip or knee replacement."( Ximelagatran and melagatran compared with dalteparin for prevention of venous thromboembolism after total hip or knee replacement: the METHRO II randomised trial.
Bergqvist, D; Bylock, A; Dahl, OE; Eriksson, BI; Eriksson, UG; Frison, L; Gustafsson, D; Kälebo, P; Lindbratt, S; Welin, L, 2002
)
0.58
" In this report, we describe a woman with primary antiphospholipid antibody syndrome who developed extensive pulmonary embolism despite receiving a proven therapeutic dosage of low molecular weight heparin."( Low-molecular weight heparin: treatment failure in a patient with primary antiphospholipid antibody syndrome.
Ahmed, S; Karim, A; Mattana, J; Patel, D; Siddiqui, R, 2002
)
0.31
" The general use and correct dosage of low-molecular-weight heparin, however, are still under debate."( Low-molecular-weight heparin in arterial reconstructive surgery: a double-blind, randomized dose-finding trial.
Eckmann, C; Kujath, P; Misselwitz, F, 2002
)
0.31
" Dosing was determined individually by the investigators with a goal of maintaining an AT activity of 80 to 150 percent."( Use of recombinant human antithrombin in patients with congenital antithrombin deficiency undergoing surgical procedures.
Bauer, KA; Bonfiglio, J; Greist, A; Holmes, HE; Konkle, BA; Weinstein, R, 2003
)
0.32
" Further study of this product is needed to define optimal dosing and further assess clinical response."( Use of recombinant human antithrombin in patients with congenital antithrombin deficiency undergoing surgical procedures.
Bauer, KA; Bonfiglio, J; Greist, A; Holmes, HE; Konkle, BA; Weinstein, R, 2003
)
0.32
"Clivarin was administered subcutaneously at a fixed daily dosage of 1750 U without any adjustment or loading dosage."( Investigations of the immunoglobulin subtype transformation of anti-heparin-platelet factor 4 antibodies during treatment with a low-molecular-weight heparin (clivarin) in orthopedic patients.
Ahmad, S; Bacher, HP; Fareed, J; Hoppensteadt, DA; Lassen, MR; Leitz, H; Misselwitz, F; Walenga, JM, 2003
)
0.32
" Three enoxaparin dosing strategies had been prescribed: therapeutic, prophylactic, or adjusted."( Prescribing patterns and outcomes of enoxaparin for anticoagulation of atrial fibrillation.
Adamson, R; Khazan, M; Mathis, AS; Scheuering, S, 2003
)
0.32
" Further study is necessary to elucidate more fully the appropriate dosing strategy for this agent in the treatment of atrial fibrillation."( Prescribing patterns and outcomes of enoxaparin for anticoagulation of atrial fibrillation.
Adamson, R; Khazan, M; Mathis, AS; Scheuering, S, 2003
)
0.32
" Dosage adjustments were made for patients developing renal failure."( Low molecular weight heparin for the prevention of hepatic veno-occlusive disease (VOD) after hematopoietic stem cell transplantation: a prospective phase II study.
Couban, SH; Dorcas, VG; Forrest, DL; Pierce, R; Thompson, K, 2003
)
0.32
" The lowest dose-response curve was at 36 weeks' gestation."( A longitudinal study of maternal dose response to low molecular weight heparin in pregnancy.
Back, DJ; Cowan, C; Farquharson, RG; Quenby, SM; Sephton, V; Toh, CH; Topping, J, 2003
)
0.32
" On the basis of this study it is questionable to extrapolate dosing and lack of dose monitoring, in pregnant women, using data derived from a nonpregnant population."( A longitudinal study of maternal dose response to low molecular weight heparin in pregnancy.
Back, DJ; Cowan, C; Farquharson, RG; Quenby, SM; Sephton, V; Toh, CH; Topping, J, 2003
)
0.32
"Enoxaparin dosing is currently based on total body weight."( Development of a dosing strategy for enoxaparin in obese patients.
Duffull, SB; Green, B, 2003
)
0.32
"125 patients treated as inpatients for atrial fibrillation or -flutter received the LMWH Fragmin (dalteparin 2 x 100 anti-Xa units/kg, maximum dosage 2 x 10,000 anti-Xa units subcutaneously)."( Anticoagulation with the low-molecular-weight heparin dalteparin (Fragmin) in atrial fibrillation and TEE-guided cardioversion.
Bechtold, H; Fung, S; Gunzenhauser, D; Janssen, D; Sawitzki, H, 2003
)
0.78
"Enoxaparin clearance depends on body weight, and, therefore, weight-adjusted dosing is recommended to minimize interpatient variability in drug exposure and the risk of haemorrhage."( Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction.
Antman, EM; Baille, P; Becker, R; Bruno, R; Retout, S; Sanderink, GJ; Veyrat-Follet, C; Vivier, N, 2003
)
0.32
" The model was used to simulate single and multiple dosing with decreased enoxaparin doses."( Pharmacokinetics of the low molecular weight heparin enoxaparin during 48 h after bolus administration as an anticoagulant in haemodialysis.
Berland, Y; Brunet, P; Dussol, B; Guillet, B; Lorec-Penet, AM; Portugal, H; Sampol, JJ; Simon, N, 2003
)
0.32
" The dosage of LMWH was performed by body weight adjustment without dose-finding studies."( [Treatment of thrombosis with low-molecular-weight heparin. Comparison of body weight-adjusted and fixed dosage].
Harenberg, J, 2003
)
0.32
" No dose "cap" is required for obese patients, and no initial dosing adjustments are necessary in elderly and/or renally impaired patients, although some monitoring is recommended."( Tinzaparin: considerations for use in clinical practice.
Feinstein, H; Nutescu, EA; Rivers, CW; Shapiro, NL, 2003
)
0.32
" Consistent once-daily dosing may facilitate self-administration of tinzaparin in the outpatient setting."( Tinzaparin: considerations for use in clinical practice.
Feinstein, H; Nutescu, EA; Rivers, CW; Shapiro, NL, 2003
)
0.32
"The objective of this study was to evaluate the pharmacokinetic response to intravenous (IV) enoxaparin given 8-12 hr after subcutaneous (SC) dosing in patients undergoing percutaneous coronary intervention (PCI)."( Reliable anticoagulation with enoxaparin in patients undergoing percutaneous coronary intervention: The pharmacokinetics of enoxaparin in PCI (PEPCI) study.
Atherley, TH; Bigonzi, F; Chevalier, PJ; Fry, ET; Guimart, CM; Martin, JL; Ozoux, ML; Pensyl, CE; Sanderink, GJ, 2004
)
0.32
"2 IU/mL) in anti-Xa activity, which may have resulted in a dosing change."( Variability of plasma anti-Xa activities with different lots of enoxaparin.
Dager, WE; Gosselin, RC; Janatpour, KA; King, JH; Larkin, EC; Owings, JT, 2004
)
0.32
"3 IU/mL in reported anti-Xa activity, which may result in dosing changes."( Variability of plasma anti-Xa activities with different lots of enoxaparin.
Dager, WE; Gosselin, RC; Janatpour, KA; King, JH; Larkin, EC; Owings, JT, 2004
)
0.32
" Doses were selected on the basis of the expected prophylactic (75 U/kg) and therapeutic (175 U/kg) dosing of tinzaparin."( Pharmacodynamic considerations in the selection of dosage of tinzaparin for various indications: experimental studies in primates.
Fareed, J; Jeske, W, 2004
)
0.32
" Incremental cost calculations demonstrate that enoxaparin offers advantages over fondaparinux when dosed for 7 days postoperatively in this patient population."( Cost analysis of fondaparinux versus enoxaparin as venous thromboembolism prophylaxis in hip fracture surgery.
Leslie, RB; Spruill, WJ; Wade, WE,
)
0.13
"To describe dosing practices and to identify risk factors for bleeding in patients with an acute coronary syndrome (ACS) who received treatment with enoxaparin."( Dosing practices and risk factors for bleeding in patients receiving enoxaparin for the treatment of an acute coronary syndrome.
Douketis, JD; Forbes, L; Foster, GA; Macie, C, 2004
)
0.32
" Enoxaparin dosing practices, factors that might influence the safety of enoxaparin administration, and bleeding events were documented."( Dosing practices and risk factors for bleeding in patients receiving enoxaparin for the treatment of an acute coronary syndrome.
Douketis, JD; Forbes, L; Foster, GA; Macie, C, 2004
)
0.32
" Due to a longer plasma half life together with high bioavailability and a linear dose-response relationship, the drugs can be safely and effectively administered in the hospital or ambulatory settings without the need to monitor the anticoagulant effect."( Clinical application of enoxaparin.
Hofmann, T, 2004
)
0.32
"The use of weight-adjusted enoxaparin dosage in patients with renal failure results in increased bleeding complications."( Effect of renal function on the pharmacokinetics of enoxaparin and consequences on dose adjustment.
Ankri, A; Bouzamondo, A; Hulot, JS; Lechat, P; Mahé, I; Montalescot, G; Urien, S; Vantelon, C, 2004
)
0.32
" In addition, we review the use of LMWH in renal insufficiency, dosing in obese patients,and the importance of sulfate content in the efficacy of protamine sulfate as a reversing agent for LMWH."( Incomplete reversal of enoxaparin toxicity by protamine: implications of renal insufficiency, obesity, and low molecular weight heparin sulfate content.
Chawla, LS; Moore, G; Seneff, MG, 2004
)
0.32
" Further investigations as a basis of general recommendations on standard dosing regimen are outstanding for use of each LMWH in percutaneous coronary interventions, as combination with Glycoprotein IIb/IIIa-inhibitors, in acute myocardial infarction and in artificial heart valves."( Anticoagulation with low-molecular-weight heparin in patients with heart diseases.
Bechtold, H; Janssen, D, 2004
)
0.32
" The women were randomized, using a random numbers table with blocks of 12, to receive either prophylactic dosing of dalteparin or UFH starting either preconceptionally or early in pregnancy."( Treatment of antiphospholipid antibody syndrome (APS) in pregnancy: a randomized pilot trial comparing low molecular weight heparin to unfractionated heparin.
Ballem, PJ; Ensom, MH; Ensworth, S; Houlihan, E; Purkiss, S; Stephenson, MD; Tsang, P, 2004
)
0.53
"There are limited data on dosing of enoxaparin in patients with renal disease due to the routine exclusion of this population in clinical trials."( Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease.
Jackevicius, CA; Ma, JM; Yeo, E, 2004
)
0.32
"To evaluate anti-Xa level monitoring, resulting from the standards of practice as set out by our hospital's guidelines for enoxaparin dosing in renally impaired patients."( Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease.
Jackevicius, CA; Ma, JM; Yeo, E, 2004
)
0.32
" Of the 22 patients who had a change of dosing frequency from twice to once daily, 5% of trough anti-Xa levels were ( Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease.
Jackevicius, CA; Ma, JM; Yeo, E, 2004
)
0.32
"Although the relationship between anti-Xa activity, efficacy, and adverse effects has not been definitively established, anti-Xa levels can assist with dosing of enoxaparin in renally impaired patients."( Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease.
Jackevicius, CA; Ma, JM; Yeo, E, 2004
)
0.32
" Although peak serum concentrations of all compounds were inversely proportional to body weight, the percentage of change during dialysis was not related to dosage or body weight."( Effects of different dialysis membranes on serum concentrations of epoetin alfa, darbepoetin alfa, enoxaparin, and iron sucrose during dialysis.
Chester, K; McMahon, LP; Walker, RG, 2004
)
0.32
"To evaluate the ability of published dosage guidelines for enoxaparin to achieve therapeutic anticoagulation and to determine whether the routine monitoring of anti-Xa levels is still necessary at a tertiary care pediatric institution."( An assessment of published pediatric dosage guidelines for enoxaparin: a retrospective review.
Dix, DB; Hamilton, DP; Ho, SH; Wadsworth, LD; Wu, JK, 2004
)
0.32
"Most patients achieved therapeutic anticoagulation when dosed according to the published guidelines."( An assessment of published pediatric dosage guidelines for enoxaparin: a retrospective review.
Dix, DB; Hamilton, DP; Ho, SH; Wadsworth, LD; Wu, JK, 2004
)
0.32
" Eighty-five percent of pregnancies (11/13) required an upward dosage adjustment."( A prospective trial that demonstrates that dalteparin requirements increase in pregnancy to maintain therapeutic levels of anticoagulation.
Barbour, LA; Oja, JL; Schultz, LK, 2004
)
0.59
" However, emerging evidence suggests that different dosing strategies may be equivalent."( Daily vs twice daily enoxaparin in the prevention of venous thromboembolic disorders during rehabilitation following acute spinal cord injury.
Chen, D; Crandall, S; Hebbeler, SL; Marciniak, CM; Mendelewski, S; Nussbaum, S, 2004
)
0.32
" Both dosing strategies are associated with a low incidence of bleeding in patients with SCI who are undergoing rehabilitation."( Daily vs twice daily enoxaparin in the prevention of venous thromboembolic disorders during rehabilitation following acute spinal cord injury.
Chen, D; Crandall, S; Hebbeler, SL; Marciniak, CM; Mendelewski, S; Nussbaum, S, 2004
)
0.32
" IV dosing consistently achieved adequate anticoagulation."( Monitoring of enoxaparin level using citrated clotting time during percutaneous coronary intervention.
Alt, EU; Cheong, BY; Díez, JG; O'Meallie, LP, 2004
)
0.32
" The low antifactor Xa levels that were observed suggest that a reduced dose-response relationship may exist between subcutaneously administered enoxaparin and antifactor Xa activity in patients with severe burn injuries."( Antifactor Xa levels in four patients with burn injuries who received enoxaparin to prevent venous thromboembolism.
Angood, PB; Gandhi, PJ; Smith, BS; Yogaratnam, D, 2004
)
0.32
" This is the reason for the initial caution for the noninterchangeability of the anti-Xa adjusted dosing of the different LMWHs."( Generic low-molecular-weight heparins: some practical considerations.
Bick, RL; Fareed, J; Hoppensteadt, DA; Jeske, WP; Leong, WL; Wahi, R; Walenga, J, 2004
)
0.32
" This study supports the safety of dosing dalteparin based on actual body weight in obese patients."( The safety of dosing dalteparin based on actual body weight for the treatment of acute venous thromboembolism in obese patients.
Al-Yaseen, E; Anderson, J; Kovacs, MJ; Martin, J; Wells, PS, 2005
)
0.91
"We were concerned that a fixed rather than a weight-based dosing regimen of dalteparin sodium to prevent venous thromboembolism (VTE) might result in decreased efficacy in obese patients and decreased safety in elderly patients."( Efficacy and safety of fixed low-dose dalteparin in preventing venous thromboembolism among obese or elderly hospitalized patients: a subgroup analysis of the PREVENT trial.
Cohen, AT; Goldhaber, SZ; Kucher, N; Leizorovicz, A; Olsson, CG; Turpie, AG; Vaitkus, PT, 2005
)
0.83
" Dosage was adjusted according to anti-Xa levels in the patients as the pregnancies progressed."( Efficacy and safety of nadroparin in the treatment of pregnant women with antiphospholipid syndrome: a prospective cohort study.
Chiarelli, S; De Silvestro, G; Fais, G; Favaro, M; Pengo, V; Ruffatti, A; Suma, V; Todesco, S; Tonello, M, 2005
)
0.33
"The aims of this study were to investigate the influence of glomerular filtration rate (GFR) on the pharmacokinetics of subcutaneously administered enoxaparin, and to develop a practical dosing algorithm in renal impairment that can easily be used at the bedside."( Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes.
Atherton, J; Green, B; Greenwood, M; Kluver, L; Rowell, J; Saltissi, D; Westhuyzen, J, 2005
)
0.33
" Stochastic simulations were performed to identify the most suitable dosing regimen."( Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes.
Atherton, J; Green, B; Greenwood, M; Kluver, L; Rowell, J; Saltissi, D; Westhuyzen, J, 2005
)
0.33
" Knowledge of the kinetic behavior of low-molecular-weight heparins (LMWHs) and the possible utility of coagulation times for monitoring may aid in the development of safe and effective dosing algorithms for percutaneous coronary interventions."( High-dose intravenous dalteparin can be monitored effectively using standard coagulation times.
Allison, P; Bracey, A; Gilbert, J; Harlan, M; Pinto, K; Schooley, C; Wilson, JM, 2005
)
0.64
"Enoxaparin dosage for obese patients and patients with renal impairment remains controversial."( Dosage of enoxaparin among obese and renal impairment patients.
Almanric, K; Bazinet, A; Blais, N; Brunet, C; Caron, S; Lalonde, L; Martineau, J; Turcotte, I, 2005
)
0.33
"Based on Anti-Xa, no dosage adjustments are required in obese patients."( Dosage of enoxaparin among obese and renal impairment patients.
Almanric, K; Bazinet, A; Blais, N; Brunet, C; Caron, S; Lalonde, L; Martineau, J; Turcotte, I, 2005
)
0.33
"The low-molecular-weight heparin dalteparin dosed 5,000 U daily is inadequate postoperative prophylaxis in women undergoing surgery for gynecologic cancer."( Low-molecular-weight heparin (dalteparin) in women with gynecologic malignancy.
DeBernardo, RL; Duska, LR; Krasner, CN; Littell, RD; Perkins, RB, 2005
)
0.9
" Various clinical studies in unstable angina and acute coronary syndrome have proved that clivarine in a dosage of 3436anti-Xa units twice daily is an effective antithrombotic agent."( Reviparin sodium clivarine: a review of its therapeutic use.
Gore, M; Kelkar, P; Rege, N; Ross, C, 2004
)
0.32
"Specific details of dosage and monitoring were collected."( Administration of enoxaparin by continuous infusion in a naturalistic setting: analysis of renal function and safety.
Bies, RR; Bobek, MB; Dasta, JF; Feng, Y; Kane-Gill, SL; Pruchnicki, MC, 2005
)
0.33
"Subjects were administered dalteparin at a dosage of approximately 100 U/kg subcutaneously every 12 hours."( Peak antifactor xa activity produced by dalteparin treatment in patients with renal impairment compared with controls.
Billett, HH; Cheng-Lai, A; Cohen, HW; Madsen, EM; Shprecher, AR; Sinnett, MJ; Wong, ST, 2005
)
0.89
" Renal impairment does not notably influence the short elimination half-life of UFH, which unlike that of dalteparin or other low-molecular-weight heparins allows for rapid dosage adjustments to prevent hemorrhage."( Life-threatening hemorrhage after dalteparin therapy in a patient with impaired renal function.
Drewe, J; Egger, SS; Krähenbühl, S; Sawatzki, MG, 2005
)
0.82
" However, little dosing information is available regarding the use of enoxaparin in patients with renal impairment."( Dosing strategy in patients with renal failure receiving enoxaparin for the treatment of non-ST-segment elevation acute coronary syndrome.
Ankri, A; Collet, JP; Hulot, JS; Lechat, P; Montalescot, G; Urien, S, 2005
)
0.33
" Simulations were then performed to develop a dosing strategy for patients with renal impairment."( Dosing strategy in patients with renal failure receiving enoxaparin for the treatment of non-ST-segment elevation acute coronary syndrome.
Ankri, A; Collet, JP; Hulot, JS; Lechat, P; Montalescot, G; Urien, S, 2005
)
0.33
" kg(-1) x 12 h(-1) dosing regimen."( Dosing strategy in patients with renal failure receiving enoxaparin for the treatment of non-ST-segment elevation acute coronary syndrome.
Ankri, A; Collet, JP; Hulot, JS; Lechat, P; Montalescot, G; Urien, S, 2005
)
0.33
"An enoxaparin dosage reduction should be considered in acute coronary syndrome patients with creatinine clearance lower than 50 mL/min."( Dosing strategy in patients with renal failure receiving enoxaparin for the treatment of non-ST-segment elevation acute coronary syndrome.
Ankri, A; Collet, JP; Hulot, JS; Lechat, P; Montalescot, G; Urien, S, 2005
)
0.33
" The efficacy of daily dosing in critically ill patients is unknown."( Optimal dose of enoxaparin in critically ill trauma and surgical patients.
Abrams, JE; Rutherford, EJ; Schooler, WG; Skeete, DA; Sredzienski, E, 2005
)
0.33
"Daily dosing of enoxaparin is inadequate for critically ill patients and should be abandoned."( Optimal dose of enoxaparin in critically ill trauma and surgical patients.
Abrams, JE; Rutherford, EJ; Schooler, WG; Skeete, DA; Sredzienski, E, 2005
)
0.33
"This study was designed to compare the dose-response of enoxaparin, dalteparin and unfractionated heparin (UFH) on the activated clotting time (ACT), and to determine whether the ACT or aPTT can be used to monitor intravenous (IV) low molecular weight heparin (LMWH)."( The activated clotting time (ACT) can be used to monitor enoxaparin and dalteparin after intravenous administration.
Cavusoglu, E; Lakhani, M; Marmur, JD, 2005
)
0.8
"Both enoxaparin and dalteparin induced a significant rise in the ACT and aPTT, with an ACT dose-response approximately one-half the magnitude of that obtained using UFH."( The activated clotting time (ACT) can be used to monitor enoxaparin and dalteparin after intravenous administration.
Cavusoglu, E; Lakhani, M; Marmur, JD, 2005
)
0.88
"Unfractionated heparin (UFH) has been considered the standard anticoagulant for patients with non-ST-segment-elevation acute coronary syndromes (NSTE ACS), yet it has limitations, including an unpredictable dose-response and intravenous administration."( Enoxaparin and glycoprotein IIb/IIIa inhibition in non-ST-elevation acute coronary syndrome: insights from the INTERACT trial.
Goodman, S, 2005
)
0.33
" dosing regimens is not clearly established."( Anti-factor Xa kinetics after intravenous enoxaparin in patients undergoing percutaneous coronary intervention: a population model analysis.
Ankri, A; Choussat, R; Collet, JP; Hulot, JS; Lechat, P; Montalescot, G; Sanchez-Pena, P; Urien, S, 2005
)
0.33
" Pharmacokinetic studies determined optimal dosing for clinically relevant anticoagulant levels in mice."( Differential metastasis inhibition by clinically relevant levels of heparins--correlation with selectin inhibition, not antithrombotic activity.
Choi, SH; Stevenson, JL; Varki, A, 2005
)
0.33
" Anti-Xa levels may reflect inadequate dosing of low molecular weight heparin, particularly during the first trimester, and should be monitored frequently."( Budd-Chiari syndrome, systemic lupus erythematosus, and secondary antiphospholipid antibody syndrome in pregnancy.
Aisenbrey, GA; Argubright, KF; Joffe, GM, 2005
)
0.33
" Because of a severe pulmonary embolism in one study patient, an interim analysis was performed, and the dosage of certoparin was increased to 3,000 IU twice daily."( Antifactor Xa activity in critically ill patients receiving antithrombotic prophylaxis with standard dosages of certoparin: a prospective, clinical study.
Dünser, MW; Fries, DR; Friesenecker, BE; Hasibeder, WR; Jochberger, S; Lorenz, I; Luckner, G; Mayr, AJ; Mayr, V; Schobersberger, W; Ulmer, H, 2005
)
0.33
"The administration of enoxaparin, in various dosing regimens, is safe for thromboprophylaxis in morbidly obese patients undergoing bariatric surgery."( Enoxaparin for thromboprophylaxis in morbidly obese patients undergoing bariatric surgery: findings of the prophylaxis against VTE outcomes in bariatric surgery patients receiving enoxaparin (PROBE) study.
Choban, PS; Hamad, GG,
)
0.13
" The primary efficacy analysis did not demonstrate any significant trend in dose-response relationship for BAY 59-7939."( Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement.
Borris, L; Dahl, OE; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F, 2006
)
0.33
" However, there is an absence of information on dosing and pharmacokinetics of LMWH over all age groups."( Dose-finding and pharmacokinetics of therapeutic doses of tinzaparin in pediatric patients with thromboembolic events.
Chan, A; Dinyari, M; Kuhle, S; Marzinotto, V; Massicotte, P; Mitchell, D; Mitchell, LG; Pieniaszek, H; Vegh, P, 2005
)
0.33
" Since optimal dosing of subcutaneous Enoxaparin is not standardized, we conducted an observational study to compare safety and efficacy of low (4,000 U once daily) vs full dose (100 U/kg twice daily) regimens."( Subcutaneous enoxaparin following thrombolysis and intravenous unfractionated heparin in ST-elevation acute myocardial infarction: safety and efficacy of low vs full dose.
Gatti, C; Maresta, A; Parollo, R; Rubboli, A; Spinolo, L; Spitali, G, 2006
)
0.33
" Adequate anticoagulant activity was maintained throughout the 12-hour dosage interval in all study patients."( Monitoring of subcutaneous dalteparin in patients with renal insufficiency under intensive care: an observational study.
Kani, C; Maggina, N; Markantonis, SL; Nicolaou, C, 2006
)
0.63
" We recommend that care be taken with repeated dosing of dalteparin in intensive care unit patients taking inotropic drugs until observed results can be confirmed."( Monitoring of subcutaneous dalteparin in patients with renal insufficiency under intensive care: an observational study.
Kani, C; Maggina, N; Markantonis, SL; Nicolaou, C, 2006
)
0.88
"The optimal thromboprophylactic dosage regimen of low-molecular-weight heparins in high-risk general surgery remains debatable."( A randomized study comparing the efficacy and safety of nadroparin 2850 IU (0.3 mL) vs. enoxaparin 4000 IU (40 mg) in the prevention of venous thromboembolism after colorectal surgery for cancer.
Bergman, JF; Derlon, A; Laporte, S; Mismetti, P; Samama, CM; Samii, K; Simonneau, G, 2006
)
0.33
" Clexane was also used for thromboembolic complications prophylaxis during performance of operative intervention (in 40 mg daily dosage during 7-12 days)."( [Perspectives for application of heparin derivates in the treatment of patients with pulmonary cancer].
Sukhoversha, OA, 2006
)
0.33
" We sought to determine if fondaparinux offered financial advantages over low-molecular weight heparin since it is given as a fixed dose over a wide range of patient weights rather then dosed directly on weight and because fondaparinux is not associated with heparin-induced thrombocytopenia (HIT)."( Minimizing costs for treating deep vein thrombosis: the role for fondaparinux.
Jackson, WL; Moores, LK; Shorr, AF; Warkentin, TE, 2007
)
0.34
"Low-molecular-weight heparins undergo renal elimination, and therefore the proper dosing in hemodialysis (HD) patients is unclear."( A multi-dose pharmacokinetic study of dalteparin in haemodialysis patients.
Byrne, S; O'Shea, SI; Ortel, TL; Perry, SL; Szczech, LA, 2006
)
0.6
" Therefore, an oral colonic targeted heparin dosage form allowing the release of LMWH directly in the inflamed tissue would be of major interest."( Low molecular weight heparin loaded pH-sensitive microparticles.
Ghazouani, FE; Lamprecht, A; Maincent, P; Meissner, Y; Ubrich, N, 2007
)
0.34
"Once-daily dosing of prophylactic LMWH dalteparin is feasible, safe, and effective in high-risk trauma patients."( Utility of once-daily dose of low-molecular-weight heparin to prevent venous thromboembolism in multisystem trauma patients.
Cothren, CC; Moore, EE; Morgan, SJ; Smith, WR, 2007
)
0.61
"Although appropriate anticoagulation is essential to maximize the efficacy and safety of primary PCI, the optimal dosing of enoxaparin in this setting is unclear."( A novel enoxaparin regime for ST elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: a WEST sub-study.
Armstrong, PW; Buller, CE; Gordon, P; O'Neill, B; Welsh, RC; Westerhout, CM, 2007
)
0.34
" However, further studies are needed to validate the dose-response relationship and further support the clinical utility of factor VIIa in this life-threatening situation."( Recombinant activated factor VII treatment of retroperitoneal hematoma in a patient with renal failure receiving enoxaparin and clopidogrel.
Al Askar, A; Al Shimemeri, A; Arabi, Y; Cherfan, A, 2007
)
0.34
" Unlike its unfractionated heparin (UFH) counterparts, enoxaparin has a greater bioavailability, lower incidence of heparin-induced thrombocytopenia and more stable and predictable anticoagulation, allowing fixed dosing without the need for monitoring."( Enoxaparin in acute coronary syndromes.
Gibson, CM; Lee, S, 2007
)
0.34
" Dosing history and measurements of anti-Xa activity in sparse samples were recorded throughout treatment."( Anti-factor Xa activity of enoxaparin administered at prophylactic dosage to patients over 75 years old.
Alamartine, E; Berges, A; Decousus, H; Epinat, M; Laporte, S; Mismetti, P; Tranchand, B; Zufferey, P, 2007
)
0.34
" In 35 patients (34%) with renal impairment (creatinine clearance <50 ml/min), LMWH dosage was halved."( Periprocedural bridging therapy with low-molecular-weight heparin in chronically anticoagulated patients with prosthetic mechanical heart valves: experience in 116 patients from the prospective BRAVE registry.
Hammerstingl, C; Omran, H; Schmidt, H; Tripp, C; von der Recke, G, 2007
)
0.34
" Bleeding complications can be minimized by avoiding cross-over from UFH to enoxaparin or vice versa, or by reducing the dosage of enoxaparin."( Enoxaparin injection for the treatment of high-risk patients with non-ST elevation acute coronary syndrome.
Schmidt-Lucke, C; Schultheiss, HP, 2007
)
0.34
" Careful attention to dosing and excellent vascular access site management after cardiac catheterization are required to decrease the risk of bleeding and blood transfusion, which have been associated with increased mortality risk."( New anticoagulant options for ST-elevation myocardial infarction and unstable angina pectoris/non-ST-elevation myocardial infarction.
Bates, ER, 2007
)
0.34
" The dosage of enoxaparin was 1 mg/kg bodyweight twice daily in treatment phase I followed by 40 mg twice daily with a bodyweight <65 kg or 60 mg twice daily with a BW > or =65 kg in treatment phase II."( Economic evaluation of enoxaparin for anticoagulation in early cardioversion of persisting nonvalvular atrial fibrillation: a statutory health insurance perspective from Germany.
Brecht, JG; Huppertz, E; Lehmacher, W; Nixdorff, U; Schädlich, PK; Schmidt-Lucke, C; Stellbrink, C, 2007
)
0.34
" The extent to which bleeding risk is attributable to excess dosing of enoxaparin is unclear."( Enoxaparin dosing and associated risk of in-hospital bleeding and death in patients with non ST-segment elevation acute coronary syndromes.
Alexander, KP; Chen, AY; Gibler, BW; LaPointe, NM; Lytle, BL; Ohman, ME; Peterson, ED; Pollack, CV; Roe, MT, 2007
)
0.34
" Elderly patients (> or = 75 years of age) received a novel enoxaparin dosing regimen and when compared with UFH, benefited from a lower relative bleeding risk than younger patients without compromising efficacy in preventing death or MI."( ExTRACT-TIMI 25 trial: clarifying the role of enoxaparin in patients with ST-elevation myocardial infarction receiving fibrinolysis.
Gabriel, RS; White, HD, 2007
)
0.34
"To evaluate the safety and efficacy of apixaban, a potent, direct, oral inhibitor of FXa, in patients following total knee replacement (TKR), and to investigate dose-response relationships."( The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement.
Ansell, J; Davidson, BL; Deitchman, D; Gallus, A; Lassen, MR; Pineo, G, 2007
)
0.34
" We propose a new orally active heparin, Db-LHD, in a solid dosage form to effectively prevent DVT and PE."( A newly developed oral heparin derivative for deep vein thrombosis: non-human primate study.
Byun, Y; Kim, CY; Kim, SK; Lee, DY; Moon, HT; Nam, JH, 2007
)
0.34
" Other dosing regimens of enoxaparin for specific patient populations should also be assessed for safety and efficacy."( Enoxaparin dosage adjustment in patients with severe renal failure: antifactor xa concentrations and safety.
Lachish, T; Rudensky, B; Slotki, I; Zevin, S, 2007
)
0.34
" Fondaparinux is also characterized by a simple dosing regimen, no need for coagulation monitoring, and potentially a lower risk of HIT compared with LMWH."( The pharmacoeconomics of deep vein thrombosis treatment.
Shorr, AF, 2007
)
0.34
" During UFH-anticoagulated HD 75% VEGF(165) decrease after 10min was negatively associated with heparin dosage and was more profound in patients with ischemic heart disease."( Different effect of unfractionated heparin and enoxaparin on circulating proangiogenic factors during hemodialysis: A cross-over study.
Myśliwiec, M; Naumnik, B; Pawlak, K, 2007
)
0.34
"The aim of this study was to compare an individualized dosing regimen for enoxaparin to conventional dosing."( Individualized compared with conventional dosing of enoxaparin.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2008
)
0.35
"There are limited data on appropriate dosing of low-molecular-weight heparins (LMWHs) for venous thromboembolism (VTE) prophylaxis in bariatric surgery."( Prophylaxis of thromboembolism in bariatric surgery with parnaparin.
Cuocolo, A; De Caterina, M; Ferrari, P; Forestieri, P; Formato, A; Pilone, V; Quarto, G; Ruocco, A, 2007
)
0.34
" During the preoperative dosing phase, parnaparin dose-dependently prolonged APTT, with the 6400 IU dose significantly prolonging APTT versus the lower doses."( Prophylaxis of thromboembolism in bariatric surgery with parnaparin.
Cuocolo, A; De Caterina, M; Ferrari, P; Forestieri, P; Formato, A; Pilone, V; Quarto, G; Ruocco, A, 2007
)
0.34
"The dose-response data reported in this preliminary study suggest that parnaparin doses of 4250 and 6400 IU may provide effective prophylaxis for VTE in patients undergoing bariatric surgery."( Prophylaxis of thromboembolism in bariatric surgery with parnaparin.
Cuocolo, A; De Caterina, M; Ferrari, P; Forestieri, P; Formato, A; Pilone, V; Quarto, G; Ruocco, A, 2007
)
0.34
"Limited data exist regarding efficacy and dosing of low-molecular-weight heparins, including enoxaparin, for morbidly obese patients."( Anti-Xa levels in bariatric surgery patients receiving prophylactic enoxaparin.
Kuhl, DA; Lee, MD; Madan, AK; Rowan, BO; Tichansky, DS, 2008
)
0.35
" Dosage of 40 mg every 12 h may not be sufficient for bariatric surgery patients."( Anti-Xa levels in bariatric surgery patients receiving prophylactic enoxaparin.
Kuhl, DA; Lee, MD; Madan, AK; Rowan, BO; Tichansky, DS, 2008
)
0.35
" Evidence-based recommendations regarding the dosing and duration of thromboprophylaxis are lacking for morbidly obese surgical patients."( Enoxaparin thromboprophylaxis in gastric bypass patients: extended duration, dose stratification, and antifactor Xa activity.
Borkgren-Okonek, MJ; Gordon, N; Guske, PJ; Hart, RW; Kane, JM; Pantano, JE; Rantis, PC; Sambol, NC,
)
0.13
"This BMI-stratified, extended enoxaparin dosing regimen provided well-tolerated, effective prophylaxis against venous thromboembolism in patients undergoing gastric bypass surgery."( Enoxaparin thromboprophylaxis in gastric bypass patients: extended duration, dose stratification, and antifactor Xa activity.
Borkgren-Okonek, MJ; Gordon, N; Guske, PJ; Hart, RW; Kane, JM; Pantano, JE; Rantis, PC; Sambol, NC,
)
0.13
"Important CKD disagreements occur in approximately 20% of acute coronary syndrome patients, affecting dosing adjustments in those already susceptible to bleeding."( Cockcroft-Gault versus modification of diet in renal disease: importance of glomerular filtration rate formula for classification of chronic kidney disease in patients with non-ST-segment elevation acute coronary syndromes.
Alexander, KP; Chen, AY; Gibler, WB; Harrington, RA; Melloni, C; Newby, LK; Ohman, EM; Peterson, ED; Roe, MT; Spinler, SA; Szczech, LA, 2008
)
0.35
" Dosing stopped at contrast venography, 12 to 15 days after surgery."( Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.
Caprini, JA; Clements, ML; Comp, PC; Davidson, BL; Francis, CW; Friedman, RJ; Ginsberg, JS; Hantel, S; Huo, MH; Lieberman, JR; Muntz, JE; Raskob, GE; Schnee, JM, 2009
)
0.35
" Although VTE prophylaxis is recommended in bariatric surgery, data with regard to monitoring and appropriate dosing of low-molecular-weight heparin are limited."( Comparison of two low-molecular-weight heparin dosing regimens for patients undergoing laparoscopic bariatric surgery.
Kuhl, DA; Lee, MD; Madan, AK; Simone, EP; Tichansky, DS, 2008
)
0.35
"Enoxaparin 60-mg every 12 h was superior to a dosage of 40 mg every 12 h in achieving therapeutic anti-Xa concentrations and avoiding subtherapeutic anti-Xa levels."( Comparison of two low-molecular-weight heparin dosing regimens for patients undergoing laparoscopic bariatric surgery.
Kuhl, DA; Lee, MD; Madan, AK; Simone, EP; Tichansky, DS, 2008
)
0.35
" However, little pharmacodynamic data are available for determining the appropriate dosing and monitoring (by anti-Factor Xa levels) of intravenous enoxaparin."( Experience with intravenous enoxaparin in critically ill infants and children.
Crary, SE; Journeycake, JM; Van Orden, H, 2008
)
0.35
" We evaluated three dosage regimens of postoperative enoxaparin in Japanese patients undergoing elective total hip or knee arthroplasty."( Prevention of postoperative venous thromboembolism in Japanese patients undergoing total hip or knee arthroplasty: two randomized, double-blind, placebo-controlled studies with three dosage regimens of enoxaparin.
Fuji, T; Fujita, S; Niwa, S; Ochi, T, 2008
)
0.35
" The dosage regimens of enoxaparin were 20 mg once daily (qd), 40 mg qd, 20 mg twice daily (bid), or placebo for 14 consecutive days."( Prevention of postoperative venous thromboembolism in Japanese patients undergoing total hip or knee arthroplasty: two randomized, double-blind, placebo-controlled studies with three dosage regimens of enoxaparin.
Fuji, T; Fujita, S; Niwa, S; Ochi, T, 2008
)
0.35
"The recommended dosage of tinzaparin in the treatment of thromboembolism during pregnancy is 175 IU/kg/day, as for non-pregnant subjects."( Treatment of deep venous thrombosis in pregnant women.
Grønlykke, T; Langhoff-Roos, J; Lykke, JA, 2008
)
0.35
"There are limited data on appropriate dosing of low-molecular-weight heparins (LMWH) for venous thromboembolism (VTE) prophylaxis in bariatric surgery."( Effect of prophylactic dalteparin on anti-factor Xa levels in morbidly obese patients after bariatric surgery.
Picard, F; Simoneau, MD; Vachon, A, 2010
)
0.67
"These findings indicate that the 7,500 IU dalteparin dosage is appropriate for the majority of morbidly obese patients undergoing bariatric surgery."( Effect of prophylactic dalteparin on anti-factor Xa levels in morbidly obese patients after bariatric surgery.
Picard, F; Simoneau, MD; Vachon, A, 2010
)
0.94
" The ExTRACT-TIMI 25 trial employed a novel dosing regimen for enoxaparin adjusted for age and renal function, which was designed to minimize bleeding risk while maintaining the beneficial effects of enoxaparin."( ExTRACT-TIMI 25 in perspective: key lessons regarding enoxaparin as an adjunct to fibrinolytic therapy.
Giugliano, RP; Thomas, D, 2009
)
0.35
" Enoxaparin was dosed as 1 mg/kg regardless of body weight without maximum."( Obesity in patients with non-ST-segment elevation acute coronary syndromes: results from the SYNERGY trial.
Antman, EM; Aylward, PE; Becker, RC; Califf, RM; Col, JJ; Ducas, J; Ferguson, JJ; Gallo, R; Goodman, SG; Langer, A; Levine, GN; Mahaffey, KW; Spinler, SA; Tonev, ST; White, HD, 2010
)
0.36
" Standard dosing of enoxaparin should be used in patients without extreme obesity due to limited outcome data in these patients."( Obesity in patients with non-ST-segment elevation acute coronary syndromes: results from the SYNERGY trial.
Antman, EM; Aylward, PE; Becker, RC; Califf, RM; Col, JJ; Ducas, J; Ferguson, JJ; Gallo, R; Goodman, SG; Langer, A; Levine, GN; Mahaffey, KW; Spinler, SA; Tonev, ST; White, HD, 2010
)
0.36
" Treatment can extend over weeks or months but there is no commercial pediatric dosage form of enoxaparin available."( In vitro stability of enoxaparin solutions (20 mg/mL) diluted in 4% glucose.
Jacobson, GA; Narkowicz, C; Patel, RP, 2008
)
0.35
" Enoxaparin dosing is based on patients' weight and results in decimal dosing."( Novel uses of insulin syringes to reduce dosing errors: a retrospective chart review of enoxaparin whole milligram dosing.
Bajzar, L; Bauman, ME; Bauman, ML; Belletrutti, M; Black, KL; Massicotte, MP, 2009
)
0.35
" To determine if children achieved and maintained therapeutic anti-Xa range using whole milligram dosing and to evaluate the impact of utilizing insulin syringes for administration on reducing dose measurement errors."( Novel uses of insulin syringes to reduce dosing errors: a retrospective chart review of enoxaparin whole milligram dosing.
Bajzar, L; Bauman, ME; Bauman, ML; Belletrutti, M; Black, KL; Massicotte, MP, 2009
)
0.35
"Whole milligram enoxaparin dosing administered via an insulin syringe safely and effectively, achieved therapeutic levels in infants and children."( Novel uses of insulin syringes to reduce dosing errors: a retrospective chart review of enoxaparin whole milligram dosing.
Bajzar, L; Bauman, ME; Bauman, ML; Belletrutti, M; Black, KL; Massicotte, MP, 2009
)
0.35
" The use of algorithms for dosing that incorporate pharmacogenomic information perform better than those using clinical data alone."( New issues in oral anticoagulants.
Francis, CW, 2008
)
0.35
"Despite a lack of clear recommendations to guide decision-making, reductions in enoxaparin sodium dosage in the elderly and in patients with mild and moderate renal dysfunction are common in patients with acute coronary syndrome."( Factors associated with bleeding in elderly hospitalized patients treated with enoxaparin sodium : a prospective, open-label, observational study.
Beckerman, P; Ben-Artzi, M; Ben-Yehuda, A; Haber, G; Levin, A; Muszkat, M; Varon, D, 2009
)
0.35
" After initial LMWH, patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol."( A randomised open-label trial comparing long-term sub-cutaneous low-molecular-weight heparin compared with oral-anticoagulant therapy in the treatment of deep venous thrombosis.
Bonell, A; Cairols, MA; Colomé, E; Lapiedra, O; Martí, X; Romera, A; Vila-Coll, R, 2009
)
0.35
" The betrixaban dosage was blinded, but enoxaparin was not."( A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT).
Bauer, KA; Davidson, BL; Fisher, WD; Gent, M; Gretler, DD; Huo, MH; Sinha, U; Turpie, AG, 2009
)
0.35
" Its consistent and predictable pharmacokinetics and pharmacodynamics across a wide range of patient populations allow administration with fixed dosing and with no coagulation monitoring."( [Rivaroxaban (Xarelto): efficacy and safety].
Arnaout, L; Bellamy, L; Chabbouh, T; Rosencher, N, 2008
)
0.35
" Consecutive patients receiving enoxaparin at a dosage of 1 mg/kg body weight/12 hours for temporary interruption of phenprocoumon were prospectively enrolled to the study."( How useful is determination of anti-factor Xa activity to guide bridging therapy with enoxaparin? A pilot study.
Hammerstingl, C; Omran, H; Poetzsch, B; Tripp, C, 2009
)
0.35
"Although weight-based nomograms have improved the efficacy and safety of dosing unfractionated heparin in ST-segment elevation myocardial infarction, achieving therapeutic anticoagulation in practice remains challenging."( Predictors of initial nontherapeutic anticoagulation with unfractionated heparin in ST-segment elevation myocardial infarction.
Antman, EM; Cheng, S; Morrow, DA; Sabatine, MS; Sloan, S, 2009
)
0.35
"In the Enoxaparin and Thrombolysis in Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis in Myocardial Infarction (ExTRACT-TIMI) 25 study, 20 506 patients with ST-segment elevation myocardial infarction were randomized to enoxaparin or unfractionated heparin, the latter dosed according to the American College of Cardiology/American Heart Association weight-based nomogram with centrally monitored activated partial thromboplastin times (aPTTs)."( Predictors of initial nontherapeutic anticoagulation with unfractionated heparin in ST-segment elevation myocardial infarction.
Antman, EM; Cheng, S; Morrow, DA; Sabatine, MS; Sloan, S, 2009
)
0.35
" These findings should be considered when dosing unfractionated heparin in support of fibrinolytic therapy."( Predictors of initial nontherapeutic anticoagulation with unfractionated heparin in ST-segment elevation myocardial infarction.
Antman, EM; Cheng, S; Morrow, DA; Sabatine, MS; Sloan, S, 2009
)
0.35
" We completed a pharmacokinetic study in morbidly obese, medically-ill patients to determine if weight-based dosing of enoxaparin for VTE prophylaxis was feasible, without excessive levels of anticoagulation, as determined by peak anti-Xa levels."( Weight-based dosing of enoxaparin for VTE prophylaxis in morbidly obese, medically-Ill patients.
Draper, L; Pendleton, RC; Rodgers, GM; Rondina, MT; Wheeler, M, 2010
)
0.36
" For the prophylaxis of thrombotic events, low-molecular heparin at a dosage of 40-60 IE/kg was administered postpartum for 14 days."( Treatment of patients with dysfibrinogenemia and a history of abortions during pregnancy.
Galanakis, D; Miesbach, W; Scharrer, I, 2009
)
0.35
" Since parenteral administration requires medical assistance and is not the most convenient route of application, the development of an oral dosage form of heparin would improve patients' comfort and replace vitamin K antagonists."( Granules in the improvement of oral heparin bioavailability.
Bonneaux, F; Lecompte, T; Maincent, P; Rabiskova, M; Scala-Bertola, J, 2009
)
0.35
"To evaluate how enoxaparin is dosed in contemporary clinical practice as a function of patients' total body weight (TBW) and body mass index (BMI), and to determine any association between dose and major bleeding."( Weight-based dosing of enoxaparin in obese patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE initiative.
Alexander, KP; Gibler, WB; Ohman, EM; Ou, FS; Peterson, ED; Pollack, CV; Roe, MT; Spinler, SA, 2009
)
0.35
" Thus, further study of enoxaparin dosing in very obese patients with non-ST-segment elevation acute coronary syndromes is warranted."( Weight-based dosing of enoxaparin in obese patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE initiative.
Alexander, KP; Gibler, WB; Ohman, EM; Ou, FS; Peterson, ED; Pollack, CV; Roe, MT; Spinler, SA, 2009
)
0.35
" While patients with renal impairment have a higher risk of bleeding and dosing of heparins is more difficult, there are no specific recommendations for bridging the latter patients."( Bridging of oral anticoagulation with low-molecular-weight heparin: experience in 373 patients with renal insufficiency undergoing invasive procedures.
Hammerstingl, C; Omran, H, 2009
)
0.35
"Low-molecular-weight heparins are effective as initial therapy for pulmonary embolism (PE) in a weight-based dosing regimen up to known body weights of 160 kg."( Treatment of pulmonary embolism in an extremely obese patient.
Diepstraten, J; Hackeng, CM; Knibbe, CA; Snijder, RJ; van Kralingen, S; van Ramshorst, B, 2009
)
0.35
" Antifactor Xa activity (anti-Xa) has been used to monitor enoxaparin dosing but its accuracy and availability are problematic."( Thrombelastography versus AntiFactor Xa levels in the assessment of prophylactic-dose enoxaparin in critically ill patients.
Cho, SD; Morris, MS; Schreiber, MA; Underwood, SJ; Van, PY; Watters, JM, 2009
)
0.35
" Despite the comprehensive and extensive nature of this program, it had some logistic issues that included the dosing of the enoxaparin which was not only inconsistent with the recommendations but the dosages used were not optimal."( Interpretation of benefit-risk of enoxaparin as comparator in the RECORD program: rivaroxaban oral tablets (10 milligrams) for use in prophylaxis in deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Haque, W; Kalodiki, E; Litinas, E; Rao, G; Van Thiel, D; Wahi, R,
)
0.13
"The administration of stack-on UFH to subjects already receiving recommended enoxaparin dosing may result in over-anticoagulation, and should be avoided."( Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study.
Bal dit Sollier, C; Drouet, L; Martin, J, 2009
)
0.35
"Therapeutically dosed dalteparin accumulates in patients with severe RI (group C)."( Study of bioaccumulation of dalteparin at a therapeutic dose in patients with renal insufficiency.
Brodmann, D; Fischer, AG; Odermatt, Y; Schmid, P; Wuillemin, WA, 2009
)
0.96
" The plasma anti-Xa activity and activated partial thromboplastin time (aPTT) were estimated on fully automated coagulometer predose and at 2, 4, 6, 8, and 10 hours following dosing with 40 mg/0."( A comparison of the biological activity of 2 formulations of enoxaparin in 12 healthy volunteers.
Jaiswal, V; Madhu, S; Muniyandi, G; Natarajan, P; Saxena, R; Sharma, V, 2010
)
0.36
" In standard clinical practice laboratory monitoring is not routinely performed, with drug dosing assessed by clinical inspection of the extracorporeal circuit, and the time for fistula needle sites to stop bleeding."( Review article: Low-molecular-weight heparin as an alternative anticoagulant to unfractionated heparin for routine outpatient haemodialysis treatments.
Davenport, A, 2009
)
0.35
"To investigate the frequency of compliance with recommendations for platelet count monitoring and management of possible HIT in hospitalized patients receiving prophylaxis and treatment dosing of LMWH for at least 5 consecutive days."( Compliance with platelet count monitoring recommendations and management of possible heparin-induced thrombocytopenia in hospitalized patients receiving low-molecular-weight heparin.
Egberts, TC; Huisman, A; Schobben, AF; ten Berg, MJ; van den Bemt, PM; van Solinge, WW, 2009
)
0.35
"0% for surgical patients receiving prophylactic dosing of either dalteparin or nadroparin, and 41."( Compliance with platelet count monitoring recommendations and management of possible heparin-induced thrombocytopenia in hospitalized patients receiving low-molecular-weight heparin.
Egberts, TC; Huisman, A; Schobben, AF; ten Berg, MJ; van den Bemt, PM; van Solinge, WW, 2009
)
0.59
"Preoperatively, patients discontinued VKA for 5 +/- 1 days; in those at low risk for thrombosis, LMWH was given at a prophylactic dosage of 3800 UI (nadroparin) or 4000 UI (enoxaparin) anti-factor (F) Xa once daily the night before the procedure."( Patients requiring interruption of long-term oral anticoagulant therapy: the use of fixed sub-therapeutic doses of low-molecular-weight heparin.
Abbene, I; Caramazza, D; Casuccio, A; Lo Coco, L; Malato, A; Pizzo, G; Saccullo, G; Siragusa, S, 2010
)
0.36
" Selection of the appropriate dosage is strongly recommended."( Safety evaluation of enoxaparin in currently approved indications.
Meneveau, N, 2009
)
0.35
" Low molecular weight heparins have a more predictable bioavailability, allowing standardized dosing without individual patient monitoring."( Pharmacokinetics of subcutaneous low molecular weight heparin (enoxaparin) in dogs.
Brooks, M; Langston, VC; Lunsford, KV; Mackin, AJ,
)
0.13
"To determine if enoxaparin induces an antithrombotic effect in cats at a dosage of 1 mg/kg SC q12h and if this antithrombotic effect is predicted by anti-Xa activity."( Antithrombotic effect of enoxaparin in clinically healthy cats: a venous stasis model.
Green, HW; Hogan, DF; Sederquist, KD; Van De Wiele, CM,
)
0.13
"This pilot study demonstrates that enoxaparin, when administered at a dosage of 1 mg/kg SC q12h, produces an antithrombotic effect in a venous statsis model in clinically healthy cats."( Antithrombotic effect of enoxaparin in clinically healthy cats: a venous stasis model.
Green, HW; Hogan, DF; Sederquist, KD; Van De Wiele, CM,
)
0.13
"To evaluate the safety of individually dosed low molecular weight heparin (LMWH) for prophylaxis and treatment of thromboembolic complications in pregnancy."( Venous thromboembolism in pregnancy: prophylaxis and treatment with low molecular weight heparin.
Andersen, AS; Bergholt, T; Berthelsen, JG, 2010
)
0.36
"Individually dosed LMWH is well tolerated and safe for prophylaxis and treatment of thromboembolic complications during pregnancy, delivery and the postpartum period."( Venous thromboembolism in pregnancy: prophylaxis and treatment with low molecular weight heparin.
Andersen, AS; Bergholt, T; Berthelsen, JG, 2010
)
0.36
"Data were obtained from a randomized controlled trial (n = 118) that compared conventional dosing of enoxaparin (product label) with an individualized dosing regimen."( Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2009
)
0.35
" Simulations showed that individualized dosing decreased the probability of a bleeding or major bruising event when compared with conventional dosing, which was most noticeable in subjects with obesity and renal impairment."( Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2009
)
0.35
" Individualized dosing of enoxaparin will reduce the probability of an event."( Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2009
)
0.35
" Group A (1993-2003, n = 32) was administered a fixed dalteparin dose and a large amount of fresh frozen plasma (FFP); Group B (2004-2008, n = 10) was administered an appropriate dosage of dalteparin to maintain the ACT levels from 140 to 150 seconds and a small amount of FFP."( Administration of dalteparin based on the activated clotting time for prophylaxis of hepatic vessel thrombosis in living donor liver transplantation.
Ikegami, T; Masuda, Y; Mita, A; Miyagawa, S; Nakazawa, Y; Ohno, Y; Terada, M; Uchikawa, Y; Urata, K, 2009
)
0.94
"This study presents LMWH in a pellet dosage form, which compared to nano- or microparticles, may offer a more convenient and industrializable way of manufacture leading to an easier scale-up process."( Pellets for oral administration of low-molecular-weight heparin.
Bonneaux, F; Gajdziok, J; Lecompte, T; Maincent, P; Rabisková, M; Sapin, A; Scala-Bertola, J, 2009
)
0.35
" However, several recent developments have seriously threatened the prominence of this drug class: (i) the adoption of an early invasive strategy, frequently leading to percutaneous coronary intervention (PCI) where the dosing and monitoring of LMWH is unfamiliar to most operators, (ii) the results of the SYNERGY trial, which not only failed to establish the superiority of enoxaparin over unfractionated heparin with respect to efficacy, but also demonstrated more bleeding with LMWH, and (iii) the results of the REPLACE-2 and ACUITY trials, which have demonstrated the advantages of an ACS and PCI treatment strategy based on direct thrombin inhibition with bivalirudin."( Avoiding intelligence failures in the cardiac catheterization laboratory: Strategies for the safe and rational use of dalteparin or enoxaparin during percutaneous coronary intervention.
Bullock-Palmer, RP; Cavusoglu, E; Marmur, JD; Poludasu, S, 2009
)
0.56
" There is a lack of consensus in guidelines regarding the timing of administration and the dosage of thromboprophylactic agents."( Randomised high- and low-dose heparin prophylaxis in patients undergoing thoracotomy for benign and malignant disease: effect on thrombo-elastography.
Attaran, S; Awad, WI; Somov, P, 2010
)
0.36
"8 dosage adjustments was needed."( Do neonates, infants and young children need a higher dose of enoxaparin in the cardiac intensive care unit?
Berry, D; Chrysostomou, C; Gunawardena, S; Krallman, S; Morell, VO; Munoz, R; Orr, R; Sanchez de Toledo, J; Shiderly, D; Sonderman, S; Wang, L; Wearden, P, 2010
)
0.36
" This study was designed to determine whether paediatric-specific dosage requirements for LMWH are justified, by investigating the doses required to achieve target therapeutic ranges."( Dosing and monitoring of enoxaparin (Low molecular weight heparin) therapy in children.
Ignjatovic, V; Monagle, P; Najid, S; Newall, F; Summerhayes, R, 2010
)
0.36
" Standard prophylaxis for high risk patients includes twice-daily dosing with 30 mg enoxaparin."( Standard prophylactic enoxaparin dosing leads to inadequate anti-Xa levels and increased deep venous thrombosis rates in critically ill trauma and surgical patients.
Ardary, C; Baje, M; Barrios, C; Cinat, ME; Conniff, H; Dolich, MO; Ewing, T; Hoyt, DB; Jafari, F; Kong, A; Lekawa, ME; Malinoski, D, 2010
)
0.36
"Standard dosing of enoxaparin leads to low anti-Xa levels in half of surgical ICU patients."( Standard prophylactic enoxaparin dosing leads to inadequate anti-Xa levels and increased deep venous thrombosis rates in critically ill trauma and surgical patients.
Ardary, C; Baje, M; Barrios, C; Cinat, ME; Conniff, H; Dolich, MO; Ewing, T; Hoyt, DB; Jafari, F; Kong, A; Lekawa, ME; Malinoski, D, 2010
)
0.36
" These assays may provide useful markers to guide appropriate dalteparin (and other low-molecular weight heparin) dosing schedules to optimize anticancer effects of dalteparin in APC."( Weight-adjusted dalteparin for prevention of vascular thromboembolism in advanced pancreatic cancer patients decreases serum tissue factor and serum-mediated induction of cancer cell invasion.
Echrish, H; Ettelaie, C; Gardiner, E; Greenman, J; Li, C; Madden, LA; Maraveyas, A, 2010
)
0.95
"To explore clinical and bleeding outcomes in patients enrolled in the SYNERGY trial who had percutaneous coronary intervention (PCI) based on adherence to the dosing regimens of enoxaparin mandated by the protocol."( Enoxaparin 0.3 mg/kg IV supplement for patients transitioning to PCI after subcutaneous enoxaparin therapy for NSTE ACS: a subgroup analysis from the SYNERGY trial.
Antman, EM; Aylward, PE; Califf, RM; Cohen, M; Kleiman, NS; Lan, L; Levine, GN; Mahaffey, KW; Pieper, KS; White, HD, 2010
)
0.36
" Strategies to ensure adherence to dosing guidelines of enoxaparin during PCI should be considered."( Enoxaparin 0.3 mg/kg IV supplement for patients transitioning to PCI after subcutaneous enoxaparin therapy for NSTE ACS: a subgroup analysis from the SYNERGY trial.
Antman, EM; Aylward, PE; Califf, RM; Cohen, M; Kleiman, NS; Lan, L; Levine, GN; Mahaffey, KW; Pieper, KS; White, HD, 2010
)
0.36
" This study implemented CDSS in an environment independent of CPOE, introduced to prescribers via academic detailing, to address the dosing of renally cleared drugs."( Clinical decision support implemented with academic detailing improves prescribing of key renally cleared drugs in the hospital setting.
Adams, RJ; Belcher, TW; Cheney, PC; Farmer, CJ; Govis, SM; Roberts, GW; Walsh, SA,
)
0.13
"The rate of dosing conformity and management for key renally cleared drugs in hospitalized patients, before and after GFR+ implementation."( Clinical decision support implemented with academic detailing improves prescribing of key renally cleared drugs in the hospital setting.
Adams, RJ; Belcher, TW; Cheney, PC; Farmer, CJ; Govis, SM; Roberts, GW; Walsh, SA,
)
0.13
"Improvements were seen in dosing conformity for enoxaparin (from 68% to 86%, p=0."( Clinical decision support implemented with academic detailing improves prescribing of key renally cleared drugs in the hospital setting.
Adams, RJ; Belcher, TW; Cheney, PC; Farmer, CJ; Govis, SM; Roberts, GW; Walsh, SA,
)
0.13
"Clinical decision support implemented with academic detailing improved dosing conformity and management of key renally cleared drugs in a hospitalized population."( Clinical decision support implemented with academic detailing improves prescribing of key renally cleared drugs in the hospital setting.
Adams, RJ; Belcher, TW; Cheney, PC; Farmer, CJ; Govis, SM; Roberts, GW; Walsh, SA,
)
0.13
"To assess the prescribing practice of enoxaparin in comparison to dosing guidelines."( Current enoxaparin dosing guidelines have dubious credibility.
Al-Sallami, H; Duffull, S; Ferguson, R; Jordan, S; Medlicott, N; Schollum, J, 2010
)
0.36
"Current enoxaparin dosing guidelines are too simplistic and result in discord between dosing in practice and that approved by Medsafe."( Current enoxaparin dosing guidelines have dubious credibility.
Al-Sallami, H; Duffull, S; Ferguson, R; Jordan, S; Medlicott, N; Schollum, J, 2010
)
0.36
" Multiple drugs and dosing regimens have been suggested for pharmacoprophylaxis."( Gold Medal Forum Winner. Unfractionated heparin three times a day versus enoxaparin in the prevention of deep vein thrombosis in trauma patients.
Arnold, JD; Barker, DE; Burkholder, HC; Dart, BW; Longley, JM; Maxwell, RA; Mejia, VA; Smith, PW, 2010
)
0.36
"The aim of the present study was to evaluate whether a once- or twice-daily dosing regimen would be feasible in children to achieve appropriate plasma levels of enoxaparin."( Population pharmacokinetics of enoxaparin in infants, children and adolescents during secondary thromboembolic prophylaxis: a cohort study.
Hempel, G; Krümpel, A; Male, C; Mitchell, L; Nowak-Göttl, U; Trame, MN, 2010
)
0.36
"9 years) receiving enoxaparin either as a once- or twice-daily dosing regimen."( Population pharmacokinetics of enoxaparin in infants, children and adolescents during secondary thromboembolic prophylaxis: a cohort study.
Hempel, G; Krümpel, A; Male, C; Mitchell, L; Nowak-Göttl, U; Trame, MN, 2010
)
0.36
"The model is capable of describing all age groups and dosing levels of our population and predicts 12 h and 24 h enoxaparin activities sufficiently."( Population pharmacokinetics of enoxaparin in infants, children and adolescents during secondary thromboembolic prophylaxis: a cohort study.
Hempel, G; Krümpel, A; Male, C; Mitchell, L; Nowak-Göttl, U; Trame, MN, 2010
)
0.36
"001) dose-response for efficacy across the edoxaban dose groups for total VTE and for major VTE."( Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study.
Bocanegra, T; Cohen, AT; Eriksson, BI; Puskas, D; Raskob, G; Shi, M; Weitz, JI, 2010
)
0.36
" It is a hydrophilic molecule that is, predominantly, eliminated renally with few data to support dosing for subjects with renal impairment and/or obesity."( Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2010
)
0.36
" A matched comparison of the two dosing strategies was undertaken using individual model predicted anti-Xa concentrations generated every 30 minutes to 120 hours post initiation of therapy."( Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2010
)
0.36
"When compared with conventional dosing, individualized dosing in subjects with renal impairment resulted in a significantly greater proportion of time in the therapeutic range (median [range] = 69."( Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2010
)
0.36
"Individualized dosing in subjects with renal impairment is more effective than conventional dosing at achieving and maintaining therapeutic anti-Xa concentrations, which could decrease the risk of bleeding events and mortality in these subjects."( Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations.
Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2010
)
0.36
"Standard dosing of enoxaparin in lung transplant recipients is associated with a high incidence of supratherapeutic anti-Xa levels."( Supratherapeutic anticoagulation from low-molecular-weight heparin in lung transplant recipients.
Blanc, PD; Boettger, RF; Golden, J; Hoopes, C; Huang, MY; Hui, C; Leard, LE; Singer, JP; Watkins, K, 2010
)
0.36
" The first received low-molecular-weight heparin for 10 days at therapeutic dosage (nadroparin 180 anti-activated factor X units once daily) and compression therapy for three months, and the second received compression therapy alone."( Therapy of isolated calf muscle vein thrombosis: a randomized, controlled study.
Beyer, J; Buschmann, L; Halbritter, K; Rastan, A; Schellong, S; Schwarz, T, 2010
)
0.36
"A model-based approach was used to integrate data from a phase II study in order to provide a quantitative rationale for selecting the apixaban dosage regimen for a phase III trial."( Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose.
Feng, Y; Leil, TA; Mohan, P; Paccaly, A; Pfister, M; Zhang, L, 2010
)
0.36
" These results are consistent with empirical evidence from the literature and reflect the inadequacy of current dosing strategies in achieving desired biomarker targets."( Routine plasma anti-Xa monitoring is required for low-molecular-weight heparins.
Al-Sallami, HS; Barras, MA; Duffull, SB; Green, B, 2010
)
0.36
" Inadequate dosage has been pointed out as a potential problem because the use of subjectively estimated weight instead of real measured weight is common practice in the emergency department (ED)."( Error in body weight estimation leads to inadequate parenteral anticoagulation.
de Oliveira, L; dos Reis Macedo, LG; Garcia, AA; Pazin-Filho, A; Pintão, MC, 2011
)
0.37
"Despite the growing epidemic of obesity in the United States, dosing medications in such patients remains poorly studied and understood."( Pharmacotherapy in the critically ill obese patient.
Medico, CJ; Walsh, P, 2010
)
0.36
"Altered pharmacokinetics in critically ill patients have been shown to result in inadequate enoxaparin dosing for venous thromboembolism (VTE) prophylaxis."( Enoxaparin and antifactor Xa levels in acute burn patients.
Cochran, A; Faraklas, I; Lin, H; Saffle, J,
)
0.13
" Dosing schedules based on pharmacodynamic and clinical data offer a seamless transition for enoxaparin from the medical management phase to PCI."( Use of low-molecular-weight heparins during percutaneous coronary intervention.
Martin, JL; Slepian, M, 2011
)
0.37
"A retrospective chart review was conducted of all trauma patients older than 18 years of age admitted to Shands at the University of Florida between July 1, 2005 and June 30, 2007, who received either dosing regimen."( Review of a large clinical series: once- versus twice-daily enoxaparin for venous thromboembolism prophylaxis in high-risk trauma patients.
Bush, S; Hampp, C; LeClaire, A; Lottenberg, L,
)
0.13
"A total of 409 patients were treated with once-daily dosing and 278 patients were treated with twice-daily dosing."( Review of a large clinical series: once- versus twice-daily enoxaparin for venous thromboembolism prophylaxis in high-risk trauma patients.
Bush, S; Hampp, C; LeClaire, A; Lottenberg, L,
)
0.13
" Further study is needed to clarify which dosing regimen of enoxaparin is superior with regard to safety and effectiveness."( Review of a large clinical series: once- versus twice-daily enoxaparin for venous thromboembolism prophylaxis in high-risk trauma patients.
Bush, S; Hampp, C; LeClaire, A; Lottenberg, L,
)
0.13
"Weight-based dosing for enoxaparin is recommended in the 2008 American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) prophylaxis."( Increased enoxaparin dosing is required for obese children.
Dunlap, M; Johnson, PN; Lewis, TV; Nebbia, AM, 2011
)
0.37
" Areas under the curve (AUCs) for a 12-hour dosing interval were estimated."( Factors influencing enoxaparin anti-Xa activity in surgical critically ill patients.
Albert, M; Blais, L; Boulanger, I; Champagne, MC; Vincent, PD; Williamson, DR; Zikos, T, 2011
)
0.37
"Our purpose was to describe anti-Xa levels, dosage requirements, and complications associated with enoxaparin treatment doses in patients with morbid obesity."( Evaluation of therapeutic anticoagulation with enoxaparin and associated anti-Xa monitoring in patients with morbid obesity: a case series.
Deal, EN; Hollands, JM; Reichley, RM; Riney, JN; Skrupky, LP; Smith, JR, 2011
)
0.37
" Since repetitive dosing is usually needed for thromboprophylaxis, study objectives were to determine whether repetitive oral heparin prevented arterial thrombosis and to compare effectiveness to subcutaneous administration."( Repeated doses of oral and subcutaneous heparins have similar antithrombotic effects in a rat carotid arterial model of thrombosis.
Hiebert, LM; Ping, T; Wice, SM, 2012
)
0.38
" The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies."( Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.
Burghaus, R; Coboeken, K; Gaub, T; Kuepfer, L; Lippert, J; Mueck, W; Sensse, A; Siegmund, HU; Weiss, W, 2011
)
0.37
" Most clinicians use a fixed dosage of LMWH in pregnant APS women despite the fact that there are no clinical trials establishing that fixed doses are more efficacious than adjusted ones in preventing pregnancy complications."( Adjusted prophylactic doses of nadroparin plus low dose aspirin therapy in obstetric antiphospholipid syndrome. A prospective cohort management study.
Favaro, M; Gervasi, MT; Hoxha, A; Punzi, L; Ruffatti, A; Ruffatti, AT,
)
0.13
" Anti-Factor Xa (anti-FXa) plasma levels are most often employed in the assessment and guidance of accurate dosing in these patient cohorts."( Comparison of a fluorogenic anti-FXa assay with a central laboratory chromogenic anti-FXa assay for measuring LMWH activity in patient plasmas.
Castro-López, V; Harris, LF; Jenkins, PV; Killard, AJ; O'Donnell, JS, 2011
)
0.37
" Future prospective studies are needed to determine definitive conclusions regarding appropriate chemical VTE prophylaxis and dosing regimens for burn patients."( Clinically significant venous thromboembolic complications in burn patients receiving unfractionated heparin or enoxaparin as prophylaxis.
Bushwitz, J; He, J; LeClaire, A; Mozingo, D,
)
0.13
" Furthermore, the optimal dosing of enoxaparin in special populations such as renal insufficiency and obesity remains controversial."( The appropriateness of enoxaparin use in Lebanese hospitals: a quality evaluation study.
Nassif, JG; Zeineddine, MM; Zeitoun, AA, 2011
)
0.37
"(1) To assess the appropriateness of enoxaparin dosing and duration per indication in compliance with the recommended guidelines and their impact on safety and efficacy outcomes in Lebanese health care centers."( The appropriateness of enoxaparin use in Lebanese hospitals: a quality evaluation study.
Nassif, JG; Zeineddine, MM; Zeitoun, AA, 2011
)
0.37
" Data on demographics, indication, dosing regimen and clinical outcomes were collected."( The appropriateness of enoxaparin use in Lebanese hospitals: a quality evaluation study.
Nassif, JG; Zeineddine, MM; Zeitoun, AA, 2011
)
0.37
"The appropriateness of enoxaparin dosing was compared across different hospital type and among special populations including severe renal insufficiency and very obese patients."( The appropriateness of enoxaparin use in Lebanese hospitals: a quality evaluation study.
Nassif, JG; Zeineddine, MM; Zeitoun, AA, 2011
)
0.37
" When comparing the overall dosing practices in Lebanese hospitals, there was no statistically significant difference in the correctness of enoxaparin dosing between teaching and non-teaching hospitals (61."( The appropriateness of enoxaparin use in Lebanese hospitals: a quality evaluation study.
Nassif, JG; Zeineddine, MM; Zeitoun, AA, 2011
)
0.37
"This study highlighted the improper practice and thus the need of implementation of clinical practice guidelines for the dosing of enoxaparin, in Lebanese hospitals."( The appropriateness of enoxaparin use in Lebanese hospitals: a quality evaluation study.
Nassif, JG; Zeineddine, MM; Zeitoun, AA, 2011
)
0.37
"To evaluate dosing requirements and monitoring patterns of low-molecular-weight heparin (LMWH) when used in high-risk pregnancy."( Dosing and monitoring of low-molecular-weight heparin in high-risk pregnancy: single-center experience.
Chevalier, AB; Hibbard, JU; Kominiarek, MA; Nutescu, EA; Shapiro, NL, 2011
)
0.37
" The primary outcome was change in dosing requirements of LMWH throughout pregnancy as determined by the corresponding antifactor Xa activity peak levels."( Dosing and monitoring of low-molecular-weight heparin in high-risk pregnancy: single-center experience.
Chevalier, AB; Hibbard, JU; Kominiarek, MA; Nutescu, EA; Shapiro, NL, 2011
)
0.37
" However, very few studies compare different dosing regimens of the LMWH itself."( Enoxaparin once daily vs. twice daily dosing for the treatment of venous thromboembolism in cancer patients: a literature summary.
Diaz, AH; Gilreath, JA; Rodgers, GM, 2012
)
0.38
" Rivaroxaban was also effective following oral dosing at 3 mg/kg."( Arterial antithrombotic activity of rivaroxaban, an orally active factor Xa inhibitor, in a rat electrolytic carotid artery injury model of thrombosis.
Andrade-Gordon, P; Chen, C; Connelly, MA; Damiano, BP; Huang, Z; Parry, TJ; Perzborn, E, 2011
)
0.37
" The system achieved a $40 788 savings over 6 months following the conversion using approved prophylactic dosing per patient indication."( Comparative effectiveness of dalteparin and enoxaparin in a hospital setting.
Carson, W; Choe, Y; Faria, C; Parks, C; Powers, A; Schilling, B; Simons, WR, 2012
)
0.67
" Few standards exist for delineating the optimal dosing strategy for VTE prevention in obese patients, especially in the setting of major surgery or trauma."( Implementation of an enoxaparin protocol for venous thromboembolism prophylaxis in obese surgical intensive care unit patients.
Barton, RG; Kimball, EJ; Ludwig, KP; Mone, M; Simons, HJ, 2011
)
0.37
"A weight-based dosage range of enoxaparin 50-120 mg twice daily (median 60) was given to 23 patients."( Implementation of an enoxaparin protocol for venous thromboembolism prophylaxis in obese surgical intensive care unit patients.
Barton, RG; Kimball, EJ; Ludwig, KP; Mone, M; Simons, HJ, 2011
)
0.37
"Weight-based dosing with enoxaparin in morbidly obese SICU patients was effective in achieving anti-factor Xa levels within the appropriate prophylactic range."( Implementation of an enoxaparin protocol for venous thromboembolism prophylaxis in obese surgical intensive care unit patients.
Barton, RG; Kimball, EJ; Ludwig, KP; Mone, M; Simons, HJ, 2011
)
0.37
" We found significant differences in mean dosage, cost, bleeding/adverse effect, and extracorporeal circuit thrombosis between excessive and reduced nadroparin dosage groups."( Clinical safety and anticoagulation efficacy of low-molecular-weight heparins in chronic hemodialysis patients: a single medical center experience.
Chang, HW; Chen, TC; Chuang, FR; Chuang, PH; Lee, CH; Ng, HY; Su, YJ; Wang, IK; Wu, CH; Yang, CC, 2011
)
0.37
" Reduced LMWHs dosage could promote patient's safety and decreased HD cost in HD patients with excessive dosage of LMWHs."( Clinical safety and anticoagulation efficacy of low-molecular-weight heparins in chronic hemodialysis patients: a single medical center experience.
Chang, HW; Chen, TC; Chuang, FR; Chuang, PH; Lee, CH; Ng, HY; Su, YJ; Wang, IK; Wu, CH; Yang, CC, 2011
)
0.37
"Frequent occurrence of low antifactor Xa levels observed in this study demonstrated the inadequacy of standard dosing of enoxaparin for VTE prophylaxis in many patients with acute burns."( Enoxaparin dose adjustment is associated with low incidence of venous thromboembolic events in acute burn patients.
Cochran, A; Faraklas, I; Lin, H; Saffle, J, 2011
)
0.37
" Incremental IV dosing of enoxaparin (0."( Anticoagulation after subcutaneous enoxaparin is time sensitive in STEMI patients treated with tenecteplase.
Armstrong, PW; Buller, CE; Gordon, P; O'Neill, B; Welsh, RC; Westerhout, CM, 2012
)
0.38
" Compliance with prophylaxis was complete but compliance with the recommended dosage was suboptimal, which may result in venous thromboembolism after CS despite thromboprophylaxis."( Thromboprophylaxis for women undergoing caesarean section.
Farah, N; Kennedy, C; Kennelly, M; O'Dwyer, V; O'Kelly, S; Turner, MJ, 2012
)
0.38
"The purpose of this study was to analyze whether 2 standard dosing regimens of enoxaparin (30 mg twice daily vs 40 mg once daily) would result in different deep vein thrombosis (DVT) rates and anti-factor Xa activity (anti-Xa) in surgical patients."( Incidence of deep vein thrombosis is increased with 30 mg twice daily dosing of enoxaparin compared with 40 mg daily.
Differding, JA; Riha, GM; Schreiber, MA; Van, PY, 2012
)
0.38
"The incidence of DVT is increased in surgical patients who receive 30 mg twice daily dosing of enoxaparin compared with 40 mg daily."( Incidence of deep vein thrombosis is increased with 30 mg twice daily dosing of enoxaparin compared with 40 mg daily.
Differding, JA; Riha, GM; Schreiber, MA; Van, PY, 2012
)
0.38
" We prospectively compared three enoxaparin dosing regimens for the achievement of goal peak anti-Factor Xa levels in medically ill patients (n 5 31) with extreme obesity (body mass index (BMI) ‡ 40 kg/m2)."( Prospective comparison of three enoxaparin dosing regimens to achieve target anti-factor Xa levels in hospitalized, medically ill patients with extreme obesity.
Freeman, A; Horner, T; Pendleton, RC; Rondina, MT, 2012
)
0.38
" Thrombotic storm was defined as newly diagnosed multisite venous thromboembolism (VTE) with acute thrombus progression despite conventional or higher than conventional dosing of heparin or low molecular weight heparin."( Treatment, survival, and thromboembolic outcomes of thrombotic storm in children.
Gibson, E; Goldenberg, NA; Knoll, CM; Manco-Johnson, MJ; Mourani, PM; Soep, J; Wang, M, 2012
)
0.38
"Rats were treated with single oral administration of edoxaban, repeated oral dosing of warfarin for 4 days and single subcutaneous administration of enoxaparin before thrombosis or haemorrhage induction."( Comparison of antithrombotic and haemorrhagic effects of edoxaban, an oral direct factor Xa inhibitor, with warfarin and enoxaparin in rats.
Edo, N; Honda, Y; Kamisato, C; Kita, A; Morishima, Y; Shibano, T; Tsuji, N, 2012
)
0.38
" This starting dosage may be inadequate, leading to a delay in achieving therapeutic anti-factor Xa plasma concentrations."( Retrospective evaluation of enoxaparin dosing in patients 48 weeks' postmenstrual age or younger in a neonatal intensive care unit.
Christensen, ML; Hicks, JK; Sahni, JK; Shelton, CM,
)
0.13
" Logistic regression models were used to test the effect of LMWH dosage on all three outcomes."( Influence of low-molecular-weight heparin dosage on red blood cell transfusion, lymphocele rate and drainage duration after open radical prostatectomy.
Budäus, L; Graefen, M; Heinzer, H; Huland, H; Jonas, L; Karakiewicz, PI; Larbig, R; Schlomm, T; Schmitges, J; Steuber, T; Trinh, QD, 2012
)
0.38
"The mean initial anti-Xa level was higher in obese pediatric patients compared with non-obese pediatric patients, but a dosage adjustment was not required."( Comparison of anti-Xa levels in obese and non-obese pediatric patients receiving treatment doses of enoxaparin.
Bomgaars, L; Kim, S; Mahoney, D; Moffett, BS; Richard, AA; Yee, DL, 2013
)
0.39
" However, a delay in dosing could occur for clinical or logistical reasons."( Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis.
Clemens, A; Dahl, OE; Eriksson, BI; Hantel, S; Kurth, AA; Rosencher, N, 2012
)
0.38
" Results in patients with dosing delayed more than 4h postsurgery were compared with those of patients without a delay."( Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis.
Clemens, A; Dahl, OE; Eriksson, BI; Hantel, S; Kurth, AA; Rosencher, N, 2012
)
0.38
" A dose-response effect was not identified."( Dalteparin low molecular weight heparin (LMWH) in ovarian cancer: a phase II randomized study.
Elit, LM; Hoskins, P; Julian, DH; Julian, JA; Lee, AY; Levine, MN; Liaw, PC; Parpia, S; Swystun, LL, 2012
)
1.82
"Enoxaparin sodium has predictable pharmacokinetics that allow for simplified dosing without laboratory monitoring."( Enoxaparin outcomes in patients with moderate renal impairment.
Clairmont, MA; DeCarolis, DD; Johnson, GJ; Leuthner, AM; Rector, TS; Thorson, JG, 2012
)
0.38
" Inappropriate dosing of LMWH suggested by subtherapeutic and supratherapeutic antifactor Xa levels were very high in patients with different levels of kidney dysfunction."( Are low-molecular-weight heparins appropriately dosed in patients with CKD stage 3 to 5?
Altun, B; Arici, M; Buyukasik, Y; Erdem, Y; Kocak, T; Yildirim, T; Yilmaz, R, 2012
)
0.38
" While dosing of LMWH based on weight alone is standard for most non-pregnant patients, there is no data on the utility of this approach in pregnancy."( Weight-adjusted dosing of tinzaparin in pregnancy.
Gibson, PS; Jiang, X; Mansoor, A; Newell, K; Ross, S; Sam, DX; Tang, S, 2013
)
0.39
" Re-dosing and monitoring was repeated monthly, and subjects were withdrawn from weight-based dosing if consecutive anti-Factor-Xa levels were outside the target range."( Weight-adjusted dosing of tinzaparin in pregnancy.
Gibson, PS; Jiang, X; Mansoor, A; Newell, K; Ross, S; Sam, DX; Tang, S, 2013
)
0.39
"Weight-based dosing of tinzaparin failed to achieve therapeutic anticoagulation in the vast majority of women, although clinical outcomes were good."( Weight-adjusted dosing of tinzaparin in pregnancy.
Gibson, PS; Jiang, X; Mansoor, A; Newell, K; Ross, S; Sam, DX; Tang, S, 2013
)
0.39
" More patients had below-knee DVT in the prophylactic dosing group."( The effects of location and low-molecular-weight heparin administration on deep vein thrombosis outcomes in trauma patients.
Alonzo, BJ; Differding, J; Hamilton, G; Kremenevskiy, I; Lee, TH; McNamara, S; Schreiber, MA; Underwood, SJ, 2013
)
0.39
" Standard prophylactic and therapeutic dosing of LMWH does not affect the rates of resolution or improvement of lower-extremity DVT."( The effects of location and low-molecular-weight heparin administration on deep vein thrombosis outcomes in trauma patients.
Alonzo, BJ; Differding, J; Hamilton, G; Kremenevskiy, I; Lee, TH; McNamara, S; Schreiber, MA; Underwood, SJ, 2013
)
0.39
" This study was designed to analyse our experience in paediatric-specific dosage requirements for enoxaparin therapy."( Dosing and monitoring of enoxaparin therapy in children: experience in a tertiary care hospital.
Andrade-Campos, MM; Fernandez-Mosteirin, N; Lucia-Cuesta, JF; Montes-Limón, AE; Rubio-Felix, D; Salvador-Osuna, C; Torres, M, 2013
)
0.39
" In a suspected case, the doctor was recommended to discontinue, decrease the dosage or keep the drug under observation; and a follow-up of the patient's platelet count was made in order to classify the relationship between the drug and thrombocytopenia."( [Incidence of drug-induced thrombocytopenia in hospitalized patients].
Álvarez-Arroyo, L; Delgado-Sánchez, O; Seco-Melantuche, R,
)
0.13
" The doctor was recommended to discontinue the drug (2), decrease the dosage (3) or keep it under observation (3), with 100% acceptance."( [Incidence of drug-induced thrombocytopenia in hospitalized patients].
Álvarez-Arroyo, L; Delgado-Sánchez, O; Seco-Melantuche, R,
)
0.13
" DE was indicated by using the same selection criteria and dosing as in the RE-MODEL and RE-NOVATE studies."( [Dabigatran etexilate use among older adults in a home-care system after hip or knee replacement surgery].
La Valle, RÁ; Saimovici, JM; Silveira, M; Waisman, GD; Zunino, S,
)
0.13
" The aim of this retrospective study was to measure the therapeutic response to standard dosing with LMWH (using anti-Xa) in patients after ablative and reconstructive surgery for head and neck cancer, and to review the associated risk of bleeding."( Low molecular weight heparin in patients undergoing free tissue transfer following head and neck ablative surgery: review of efficacy and associated complications.
Eley, KA; Parker, RJ; Watt-Smith, SR, 2013
)
0.39
" Maintaining consistent anti-Xa activity in the final medicinal product allows physicians to ensure administration of the appropriate dosage to their patients."( Reproducibility of the anti-Factor Xa and anti-Factor IIa assays applied to enoxaparin solution.
Agut, C; Anger, P; Martinez, C; Savadogo, A,
)
0.13
" We present 52 patients treated with tinzaparin anticoagulation on HD, confirming that fixed dosing is safe and efficacious with sound pharmacodynamic reason in relation to anti-Xa profiling."( Anti-Xa activity supports using a simple dosing algorithm for tinzaparin for anticoagulation in hemodialysis.
Ashman, N; Baig, ZF; Kirwan, CJ; MacCullum, PK; Platton, S, 2013
)
0.39
" Of note, for both filters and augmented pharmacologic dosing strategies, patients at highest risk for VTE were more likely to receive more intensive interventions, limiting our ability to attribute outcomes to prophylactic strategies used."( Pharmacologic and mechanical strategies for preventing venous thromboembolism after bariatric surgery: a systematic review and meta-analysis.
Brotman, DJ; Chelladurai, Y; Haut, ER; Kebede, S; Prakasa, KR; Segal, JB; Sharma, R; Shermock, K; Shihab, HM; Singh, S, 2013
)
0.39
"Extensive dose-response modeling and trial simulations were used to select the PD 0348292 dose range for the Phase 2 study."( An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery.
Boyd, RA; Cohen, AT; Dicarlo, L; Mandema, JW; Pak, R, 2013
)
0.39
" The PD 0348292 dose-response relationship for VTE was statistically significant (P < 0."( An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery.
Boyd, RA; Cohen, AT; Dicarlo, L; Mandema, JW; Pak, R, 2013
)
0.39
"Characterization of the dose-response relationship for VTE and bleeding using an adaptive Phase 2 study design provided a strong quantitative basis for Phase 3 dose selection."( An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery.
Boyd, RA; Cohen, AT; Dicarlo, L; Mandema, JW; Pak, R, 2013
)
0.39
"The optimal dosing strategy of low-molecular-weight heparins for the treatment of antenatal venous thromboembolism is not known."( Population pharmacokinetics of enoxaparin during the antenatal period.
Arya, R; Davies, JG; Green, B; Marsh, MS; Patel, JP; Patel, RK, 2013
)
0.39
" Simulations of once- versus twice-daily enoxaparin administration demonstrated that both dosing regimens would reach target 3-hour plasma concentrations throughout the duration of the pregnancy."( Population pharmacokinetics of enoxaparin during the antenatal period.
Arya, R; Davies, JG; Green, B; Marsh, MS; Patel, JP; Patel, RK, 2013
)
0.39
" Enoxaparin was administered after caesarean section using the Royal College of Obstetricians and Gynaecologists weight-adjusted dosing guidelines."( Peak plasma anti-Xa levels after first and third doses of enoxaparin in women receiving weight-based thromboprophylaxis following caesarean section: a prospective cohort study.
Casey, E; Hiscock, RJ; Newell, PA; Simmons, SW; Walker, SP, 2013
)
0.39
" In most patients with end-stage renal disease (ESRD), prophylactic dosage of enoxaparin does not appear to be associated with an increased bleeding risk and can be used without the need for monitoring and adjustment of regimens."( Use of enoxaparin in end-stage renal disease.
Coppola, B; Lai, S, 2013
)
0.39
"Increased perioperative thromboprophylaxis dosage does not increase pericardial effusion rates or mortality in proximal aortic surgery."( NICE thromboprophylaxis guidelines are not associated with increased pericardial effusion after surgery of the proximal thoracic aorta.
Bryan, AJ; Davies, A; Hussain, A; Rahman, IA, 2013
)
0.39
" The purpose of this study was to review our experience with LMWH dosing and monitoring in a cohort of transplant recipients."( Low molecular weight heparin dosing and monitoring in solid organ transplant recipients.
Gaber, AO; Moten, MA; Patel, SJ; Putney, D,
)
0.13
" They play an important role in quantifying the time course of drug effects and provide a means of understanding the impact of variability between individuals on dosing requirements."( What do we learn from repeated population analyses?
Duffull, SB; Wright, DF, 2015
)
0.42
"Previous work from the authors' group showed a risk for inadequate enoxaparin dosing for venous thromboembolism prophylaxis in adult burn patients when traditional recommendations are used."( Enoxaparin and antifactor Xa levels in pediatric acute burn patients.
Brown, A; Cochran, A; Faraklas, I; Ghanem, M,
)
0.13
" The objective of this retrospective review was to investigate the usefulness of an enoxaparin dosing algorithm using a previously published equation."( Evaluation of an enoxaparin dosing calculator using burn size and weight.
Brown, A; Cochran, A; Faraklas, I; Ghanem, M,
)
0.13
"Limited data exist regarding the efficacy of weight-based dosing of low-molecular weight heparin for venous thromboembolism (VTE) prophylaxis in obese trauma patients."( Weight-based enoxaparin dosing for venous thromboembolism prophylaxis in the obese trauma patient.
Bickford, A; Bledsoe, J; Dickerson, J; Johnston, R; Majercik, S; Smith, K; White, T, 2013
)
0.39
"This double-blind, double-dummy, randomised, phase IIb study (NCT00902928) evaluated different dosing regimens of darexaban compared with enoxaparin (randomised 1:1:1:1:1 to 15 mg twice daily [bid], 30 mg once daily [qd], 30 mg bid or 60 mg qd or enoxaparin 40 mg qd) in patients undergoing elective total hip arthroplasty."( Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3).
Agnelli, G; Eriksson, BI; Gallus, AS; Kashiwa, M; Lassen, MR; Prins, MH; Renfurm, RW; Turpie, AG, 2014
)
0.4
"Enoxaparin dosing for patients with morbid obesity is uncertain, and therefore, an elevated incidence of bleeding may exist in this group."( Assessment of bleeding events associated with short-duration therapeutic enoxaparin use in the morbidly obese.
Deal, EN; Hagopian, JC; Hollands, JM; Riney, JN, 2013
)
0.39
"Results suggest that dosing enoxaparin in morbidly obese patients (up to 175 kg in weight) with doses capped at 150 mg was not associated with increased bleeding incidence."( Assessment of bleeding events associated with short-duration therapeutic enoxaparin use in the morbidly obese.
Deal, EN; Hagopian, JC; Hollands, JM; Riney, JN, 2013
)
0.39
" The aim of this study was to test the hypothesis that higher dosing (40 mg twice daily) would improve peak anti-Xa levels and decrease venous thromboembolism."( Alternative dosing of prophylactic enoxaparin in the trauma patient: is more the answer?
Hall, ST; Kopelman, TR; O'Neill, PJ; Pieri, PG; Pressman, MS; Quan, A; Salomone, JP; Wells, JR, 2013
)
0.39
"Although higher dosing of enoxaparin led to improved anti-Xa levels, this did not equate to a statistical decrease in venous thromboembolism."( Alternative dosing of prophylactic enoxaparin in the trauma patient: is more the answer?
Hall, ST; Kopelman, TR; O'Neill, PJ; Pieri, PG; Pressman, MS; Quan, A; Salomone, JP; Wells, JR, 2013
)
0.39
"To evaluate the appropriate dosing of enoxaparin as a venous thromboembolism (VTE) prophylaxis in hospitalized obese patients."( Dosing of enoxaparin for venous thromboembolism prophylaxis in obese patients.
Alsharhan, M; Cooper, MR; Durand, C; Willett, KC, 2013
)
0.39
"Appropriate enoxaparin dosing for thromboprophylaxis in adult patients is 40 mg subcutaneously daily or 30 mg subcutaneously twice daily."( Dosing of enoxaparin for venous thromboembolism prophylaxis in obese patients.
Alsharhan, M; Cooper, MR; Durand, C; Willett, KC, 2013
)
0.39
" Prospective, randomized controlled studies are warranted to show efficacy and safety of one dosage regimen over another."( Dosing of enoxaparin for venous thromboembolism prophylaxis in obese patients.
Alsharhan, M; Cooper, MR; Durand, C; Willett, KC, 2013
)
0.39
" We administered body-weight adjusted full dose of low-molecular weight heparin (enoxaparin) in a therapeutic dosage for 10 days."( Penile Mondor's syndrome after endovenous treatment of the great saphenous vein with 1470 nm diode laser.
Knittel, M; Schwarz, T; Zeller, T; Zerweck, C, 2015
)
0.42
" Although this was a small study, there were no adverse events, suggesting the safety profile of IV enoxaparin may be similar to subcutaneous dosing with the added benefit of less pain associated with IV dosing."( IV enoxaparin in pediatric and cardiac ICU patients.
Chopra, A; Cies, JJ; Santos, L, 2014
)
0.4
"Usually, the appropriate dosage of low-molecular-weight heparin during haemodialysis is empirically based on the clinical effect."( Pharmacokinetics of dalteparin during haemodialysis.
de Groot, KA; Grootendorst, DC; Herruer, MH; Koolen, SL; Nigten, J; Schut, NH, 2013
)
0.71
"A VTE prophylaxis protocol using anti-Xa-based dalteparin dosage adjustment in high-risk trauma patients was associated with decreased VTE."( Effect of a dalteparin prophylaxis protocol using anti-factor Xa concentrations on venous thromboembolism in high-risk trauma patients.
Athota, KP; Besl, KM; Droege, CA; Droege, ME; Ernst, NE; Hanseman, DJ; Keegan, SP; Kramer, EA; Lemmink, JA; Lutomski, DM; Mueller, EW; Robinson, BR, 2014
)
1.04
" Dosing of patients with extreme body weights has not been well studied, especially dosing of low weight patients."( Anti-Xa activity after enoxaparin prophylaxis in hospitalized patients weighing less than fifty-five kilograms.
Acuña, MP; Aizman, A; Cerda, J; Ernst, D; Mellado, R; Moya, P; Rojas, L, 2013
)
0.39
" The DVT rate did not differ between trauma and general surgery populations or in patients receiving once-daily vs twice-daily dosing regimens."( Correlation of missed doses of enoxaparin with increased incidence of deep vein thrombosis in trauma and general surgery patients.
Anderson, R; Barton, JS; Cho, SD; Differding, J; Geraci, T; Louis, SG; Riha, GM; Sato, M; Schreiber, MA; Underwood, S; Van, PY; Watters, JM, 2014
)
0.4
" We hypothesized that using ΔR-guided dosing would result in decreased DVT rates."( Thromboelastogram-guided enoxaparin dosing does not confer protection from deep venous thrombosis: a randomized controlled pilot trial.
Barton, JS; Differding, JA; Ginzburg, E; Kunio, NR; Louis, SG; Rick, E; Riha, GM; Schreiber, MA; Underwood, SJ; Van, PY, 2014
)
0.4
"TEG adjusted enoxaparin dosing led to significant increases in anti-Xa activity, which did not correlate with a decreased DVT rate."( Thromboelastogram-guided enoxaparin dosing does not confer protection from deep venous thrombosis: a randomized controlled pilot trial.
Barton, JS; Differding, JA; Ginzburg, E; Kunio, NR; Louis, SG; Rick, E; Riha, GM; Schreiber, MA; Underwood, SJ; Van, PY, 2014
)
0.4
" Thus, PEGylation of ENX is a novel approach for extended and enhanced activity of ENX with a potential for decreased dosing frequency."( Development and evaluation of PEGylated Enoxaparin: a novel approach for enhanced anti-Xa activity.
Bhatt, TD; Choubey, AK; Dora, CP; Gill, MS; Suresh, S, 2014
)
0.4
"Information regarding dosing of low-molecular-weight heparins (LMWH) for therapeutic anticoagulation in hemodialysis (HD) patients is limited."( Subcutaneous enoxaparin for therapeutic anticoagulation in hemodialysis patients.
Dager, WE; Pon, TK; Roberts, AJ; White, RH, 2014
)
0.4
" Correct dosing is critical to prevent bleeding or thrombosis."( Pharmacodynamics assessment of Bemiparin after multiple prophylactic and single therapeutic doses in adult and elderly healthy volunteers and in subjects with varying degrees of renal impairment.
Antonijoan, RM; Ayani, I; Ballester, MR; Borrell, M; Fontcuberta, J; Gich, I; Gutierro, I; Martinez-Gonzalez, J; Rico, S, 2014
)
0.4
"08 for GMRs of anti-Xa activity after dosing with 4 and 16 mg/kg sugammadex, respectively."( Lack of a clinically relevant effect of sugammadex on anti-Xa activity or activated partial thromboplastin time following pretreatment with either unfractionated or low-molecular-weight heparin in healthy subjects.
Burggraaf, J; De Kam, PJ; Dennie, J; El Galta, R; Gutstein, DE; Kruithof, AC; Langdon, RB; Moerland, M; Troyer, MD; van Lierop, MJ, 2014
)
0.4
" It seems that the dosage of anticoagulant drug does not have a significant impact on thrombus resolution."( Time course and the recanalization rate of superficial vein thrombosis treated with low-molecular-weight heparin.
Jezovnik, MK; Poredos, P; Spirkoska, A, 2015
)
0.42
" The increments were directly associated with the enoxaparin dosage and strongly inversely with the predialysis levels of the enzyme."( Effects of enoxaparin on myeloperoxidase release during hemodialysis.
Borawski, J; Gozdzikiewicz, J; Koc-Zorawska, E; Mysliwiec, M, 2014
)
0.4
"To demonstrate that low-molecular-weight heparin (enoxaparin) can be used in critically ill pediatric patients to achieve target anti-factor Xa concentrations and determine appropriate dosing corrected for age and illness severity."( Higher doses of low-molecular-weight heparin (enoxaparin) are needed to achieve target anti-Xa concentrations in critically ill children*.
Abu-Sultaneh, S; Hanson, SJ; Havens, PL; Hoffmann, RG; Punzalan, RC; Schloemer, NJ; Yan, K, 2014
)
0.4
" Only 42% of critically ill children (80 of 192) and only 29% of children (9 of 31) on inotropes achieved recommended target range of anti-factor Xa concentrations on initial recommended enoxaparin dosing (1."( Higher doses of low-molecular-weight heparin (enoxaparin) are needed to achieve target anti-Xa concentrations in critically ill children*.
Abu-Sultaneh, S; Hanson, SJ; Havens, PL; Hoffmann, RG; Punzalan, RC; Schloemer, NJ; Yan, K, 2014
)
0.4
" However, younger patients and patients with higher illness severity are less likely to achieve target concentrations using currently recommended dosing and may require higher doses of enoxaparin to reach target anti-factor Xa concentrations."( Higher doses of low-molecular-weight heparin (enoxaparin) are needed to achieve target anti-Xa concentrations in critically ill children*.
Abu-Sultaneh, S; Hanson, SJ; Havens, PL; Hoffmann, RG; Punzalan, RC; Schloemer, NJ; Yan, K, 2014
)
0.4
"Enoxaparin dosing and anti-FXa values for all patients started on enoxaparin for the 6 months before and after assay change were retrospectively compiled and analyzed with a Student's t-test."( Lack of anti-factor Xa assay standardization results in significant low molecular weight heparin (enoxaparin) dose variation in neonates and children.
Greene, LA; Ignjatovic, V; Jung, M; Law, C; Monagle, P; Raffini, LJ; Walton, S, 2014
)
0.4
" These data support a pediatric randomized controlled clinical trial comparing the safety and efficacy of enoxaparin weight-based dosing with or without dose titration based on anti-FXa."( Lack of anti-factor Xa assay standardization results in significant low molecular weight heparin (enoxaparin) dose variation in neonates and children.
Greene, LA; Ignjatovic, V; Jung, M; Law, C; Monagle, P; Raffini, LJ; Walton, S, 2014
)
0.4
"Two enoxaparin dosage regimens are used as comparators to evaluate new anticoagulants for thromboprophylaxis in patients undergoing major orthopaedic surgery, but so far no satisfactory direct comparison between them has been published."( Indirect comparison meta-analysis of two enoxaparin regimens in patients undergoing major orthopaedic surgery. Impact on the interpretation of thromboprophylactic effects of new anticoagulant drugs.
Bertoletti, L; Chapelle, C; Cucherat, M; Darmon, JY; Laporte, S; Lega, JC; Mismetti, P; Zufferey, PJ, 2014
)
0.4
" The objective of this retrospective study was to determine if 40-mg daily dosing would increase the incidence of VTE."( Epidural placement does not result in an increased incidence of venous thromboembolism in combat-wounded patients.
Caruso, JD; Elster, EA; Rodriguez, CJ, 2014
)
0.4
" We investigated two different dosing regimens; fixed dose and weight-adjusted dose on the anticoagulant effects of the LMWH tinzaparin used for thromboprophylaxis in obese pregnant women."( Weight-adjusted LMWH prophylaxis provides more effective thrombin inhibition in morbidly obese pregnant women.
Higgins, JR; Ismail, SK; Norris, L; O'Shea, S, 2014
)
0.4
" To determine indication, dosage and timing of such thromboprophylaxis in this group of patients further studies are required."( The value of extended preoperative thromboprophylaxis with dalteparin in patients with ovarian cancer qualified to surgical treatment.
Dzieciuchowicz, L; Krasińska, B; Krasiński, Z; Pawlaczyk, K; Staniszewski, R; Szpurek, D; Urbanek, T; Wójcicka, K, 2014
)
0.65
"The objective of this study was to determine the impact of a pharmacy-managed pharmacokinetic dosing program on appropriate dosing of famotidine, enoxaparin, and ketorolac."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
"A large community teaching hospital implemented a pharmacy-managed pharmacokinetic dosing program for famotidine, enoxaparin, and ketorolac."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
" In all, 66% of patients were dosed appropriately in the preimplementation group (famotidine 28%, enoxaparin 85%, and ketorolac 86%) compared to 94% in the postimplementation group (famotidine 92%, enoxaparin 95%, and ketorolac 94%), P < ."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
"Implementation of a pharmacy-managed pharmacokinetic dosing program significantly improved appropriate dosing of famotidine, enoxaparin, and ketorolac."( Evaluation of a Pharmacy-Managed Pharmacokinetic Dosing Program.
Crannage, AJ; Korobey, MJ; Meyenburg, LK; Murphy, JA, 2015
)
0.42
" Initial weight-based dosing per protocol was as follows: infants (< 12 months), 150 IU kg(-1) ; children (1-12 years), 125 IU kg(-1) ; and adolescents (13-18 years), 100 IU kg(-1) ."( Multicenter dose-finding and efficacy and safety outcomes in neonates and children treated with dalteparin for acute venous thromboembolism.
Burr, S; Goldenberg, NA; Hamblin, F; Kulkarni, R; O'Brien, SH; Wallace, A, 2014
)
0.62
"Dalteparin successfully achieved targeted anti-factor Xa levels in 18 children and young adults with acute VTE with a standardized age-based dosing regimen, with a favorable safety and efficacy profile."( Multicenter dose-finding and efficacy and safety outcomes in neonates and children treated with dalteparin for acute venous thromboembolism.
Burr, S; Goldenberg, NA; Hamblin, F; Kulkarni, R; O'Brien, SH; Wallace, A, 2014
)
2.06
" No adverse events from this dosing were observed during the duration of therapy."( Achievement of therapeutic anti-Xa levels in a proven heparin-resistant patient through the use of nontraditional high-dose enoxaparin.
Conwall, K; Krajewski, KC; Krajewski, MP; Smith, K, 2015
)
0.42
"In absence of specific dosing guidelines, the optimal dose of low molecular weight heparins for thrombosis prophylaxis in morbidly obese patients (BMI>40 kg/m(2)) remains unknown."( Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint.
Diepstraten, J; Hackeng, CM; Janssen, EJ; Knibbe, CA; van Dongen, EP; van Ramshorst, B; Wiezer, RJ, 2015
)
0.42
"Patients with morbid obesity required less than the recommended 1 mg/kg enoxaparin dose to achieve therapeutic peak anti-Xa levels; therefore, initiation with lower dosages is prudent and anti-Xa monitoring should guide dosage adjustments."( Evaluation and Pharmacokinetics of Treatment Dose Enoxaparin in Hospitalized Patients With Morbid Obesity.
Chandler, WL; Liebl, PH; Muntz, JE; Putney, DR; Thompson-Moore, NR; Wanat, MA, 2015
)
0.42
" However, there is disagreement regarding the optimal dosing and duration of anticoagulant therapy."( The EFFORT trial: Preoperative enoxaparin versus postoperative fondaparinux for thromboprophylaxis in bariatric surgical patients: a randomized double-blind pilot trial.
Beselman, A; Canner, J; Chen, J; Lidor, A; Magnuson, T; Prokopowicz, G; Schweitzer, M; Steele, KE; Streiff, M; Verde, F; Wyse, R,
)
0.13
"aPTT displays a linear dose-response to LMWH."( Monitoring low molecular weight heparins at therapeutic levels: dose-responses of, and correlations and differences between aPTT, anti-factor Xa and thrombin generation assays.
Lybeck, E; Schött, U; Strandberg, K; Thomas, O; Tynngård, N, 2015
)
0.42
"Our current dosing practice of 40 mg SC for individuals with a BMI ≤50 kg/m(2) and 60 mg for individuals with a BMI ≥50 kg/m(2) resulted in anti-factor Xa activity that was sufficient for adequate thromboprophylaxis in adolescent bariatric surgical patients."( Use of Enoxaparin in Obese Adolescents During Bariatric Surgery--a Pilot Study.
Mushtaq, A; Nadler, EP; van den Anker, JN; Vaughns, JD; Ziesenitz, VC, 2015
)
0.42
" The tolerability profile demonstrated in the dose escalation schedule of lenalidomide suggests the dosing of lenalidomide to be 25 mg daily on days 1-21 with standard dosing of gemcitabine and merits further evaluation in a phase II trial."( A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer.
Liljefors, M; Rossmann, E; Ullenhag, GJ, 2015
)
0.42
"5 mg/kg SC once daily are both FDA-approved dosing regimens for the treatment of pulmonary embolism (PE)."( Once daily versus twice daily enoxaparin for acute pulmonary embolism in cancer patients.
Chisholm, G; King, AC; Ma, MQ; Toale, KM, 2016
)
0.43
"To compare the adequacy of venous thromboembolism prophylaxis based on anti-Xa concentrations between weight-based enoxaparin dosing and body mass index (BMI)-stratified dosing in morbidly obese women after cesarean delivery."( Enoxaparin dosing after cesarean delivery in morbidly obese women.
LaCoursiere, DY; Overcash, RT; Somers, AT, 2015
)
0.42
" Participants received either weight-based or BMI-stratified enoxaparin dosing to prevent venous thromboembolism formation."( Enoxaparin dosing after cesarean delivery in morbidly obese women.
LaCoursiere, DY; Overcash, RT; Somers, AT, 2015
)
0.42
" Thirty-six participants (86%) on weight-based dosing had anti-Xa concentrations within the prophylactic range compared with 11 (26%) on BMI-stratified dosing (P<."( Enoxaparin dosing after cesarean delivery in morbidly obese women.
LaCoursiere, DY; Overcash, RT; Somers, AT, 2015
)
0.42
"In morbidly obese women after cesarean delivery, weight-based dosing of enoxaparin for venous thromboembolism prophylaxis is significantly more effective than BMI-stratified dosing in achieving adequate anti-Xa concentrations."( Enoxaparin dosing after cesarean delivery in morbidly obese women.
LaCoursiere, DY; Overcash, RT; Somers, AT, 2015
)
0.42
" With distinct advantages of once daily dosing and relative safety in renal impairment, it has been used off-label in pediatric practice; however, age-based dosing guidelines, safety and efficacy data in children are evolving."( A retrospective analysis of outcomes of dalteparin use in pediatric patients: a single institution experience.
Graner, K; Mullikin, T; Pruthi, RK; Rao, AN; Rodriguez, V; Shaughnessy, WJ; Warad, D, 2015
)
0.68
" Infants (<1year) required significantly higher weight-based dosing to achieve therapeutic anti-Xa levels compared to children (1-10years) or adolescents (>10-18years) (mean dose units/kg/day; 396."( A retrospective analysis of outcomes of dalteparin use in pediatric patients: a single institution experience.
Graner, K; Mullikin, T; Pruthi, RK; Rao, AN; Rodriguez, V; Shaughnessy, WJ; Warad, D, 2015
)
0.68
" Dosing should be customized in an age-based manner with close monitoring of anti-Xa activity in order to achieve optimal levels, prevent bleeding complications, and to allow full benefit of prevention or therapy of thrombotic complications."( A retrospective analysis of outcomes of dalteparin use in pediatric patients: a single institution experience.
Graner, K; Mullikin, T; Pruthi, RK; Rao, AN; Rodriguez, V; Shaughnessy, WJ; Warad, D, 2015
)
0.68
" Therefore, we hypothesized that a weight-based enoxaparin dosing regimen would provide more adequate prophylaxis (as indicated by antifactor Xa levels) for patients in our trauma intensive care unit (TICU)."( Prospective Evaluation of Weight-Based Prophylactic Enoxaparin Dosing in Critically Ill Trauma Patients: Adequacy of AntiXa Levels Is Improved.
Becher, RD; Borgerding, EM; Farrah, JP; Kilgo, P; Lauer, C; Miller, PR; Nunez, JM; Rebo, GJ; Stirparo, JJ, 2015
)
0.42
"Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers."( Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.
Gagne, JJ; Kesselheim, AS, 2015
)
0.42
"The objective of our study was to determine the feasibility and safety of enoxaparin whole milligram dosing in premature and term neonates, and to assess response to treatment."( Feasibility and safety of enoxaparin whole milligram dosing in premature and term neonates.
Bhatt, MD; Chan, AK; Goldsmith, R; Paes, BA, 2015
)
0.42
"Whole milligram dosing of enoxaparin for thrombosis is feasible, safe and effective in premature and term neonates."( Feasibility and safety of enoxaparin whole milligram dosing in premature and term neonates.
Bhatt, MD; Chan, AK; Goldsmith, R; Paes, BA, 2015
)
0.42
"6 IU÷ml was applied, the present dosing method led to over-anticoagulation in more than half of the patients."( Anticoagulation with dalteparin and nadroparin in nocturnal haemodialysis.
van Jaarsveld, BC; Verhave, G; Weijmer, MC, 2015
)
0.74
" Here we show that a therapeutic dosage of LMWH tinzaparin reverses cisplatin resistance of A2780cis human ovarian cancer cells to the level of sensitive cells."( Low molecular weight heparin tinzaparin antagonizes cisplatin resistance of ovarian cancer cells.
Bendas, G; Pfankuchen, DB; Royer, HD; Schlesinger, M; Stölting, DP, 2015
)
0.42
" In addition we derived defined daily dosage (DDD) of prescribed anticoagulants and the low molecular heparin Enoxaparin for the years 2004-2011 from the statutory health insurance-drug-information system reports."( Prescription of enoxaparin is associated with decreasing pulmonary embolism mortality rate in Germany.
Kröger, K; Pütter, C; Reinecke, H; Sobik, HM; Stausberg, J; von Beckerath, O, 2015
)
0.42
" Despite the potential for increased pharmacotherapy among obese patients, there is a paucity of dosing guidelines for this special population."( Clinical Pharmacology of Frequently Used Intravenous Drugs During Bariatric Surgery in Adolescents.
van den Anker, JN; Vaughns, JD; Ziesenitz, VC, 2015
)
0.42
"1 IU/mL was considered subtherapeutic and the final dosage requirement was recorded."( Standard Dosing of Enoxaparin for Venous Thromboembolism Prophylaxis Is Not Sufficient for Most Patients Within a Trauma Intensive Care Unit.
Ahmed, N; Allen, J; Brevard, SB; Frotan, AM; Gonzalez, RP; Replogle, WH; Rostas, JW; Simmons, JD; Thacker, D, 2015
)
0.42
" These NCCN Guidelines Insights summarize the data supporting new dosing recommendations for VTE prophylaxis in obese patients with cancer."( Cancer-Associated Venous Thromboembolic Disease, Version 1.2015.
Ashrani, A; Bockenstedt, PL; Chesney, C; Eby, C; Engh, AM; Fanikos, J; Fenninger, RB; Fogerty, AE; Gao, S; Goldhaber, SZ; Hendrie, P; Holmstrom, B; Kuderer, N; Lee, A; Lee, JT; Lovrincevic, M; McMillian, N; Millenson, MM; Neff, AT; Ortel, TL; Paschal, R; Shattil, S; Siddiqi, T; Smock, KJ; Soff, G; Streiff, MB; Wang, TF; Yee, GC; Zakarija, A, 2015
)
0.42
" Protocols vary from center to center, but there is still no consensus regarding the proper dosage or treatment duration."( The Use of Low-Dose Recombinant Tissue Plasminogen Activator to Treat a Preterm Infant with an Intrauterine Spontaneous Arterial Thromboembolism.
Caner, İ; Demirelli, Y; Kara, M; Tekgündüz, KŞ, 2015
)
0.42
" With regard to dosage, for in-hospital treatment the higher dosage of 40 mg twice daily as opposed to 30 mg seems to significantly reduce the incidence of VTE without significantly affecting bleeding rate."( Enoxaparin venous thromboembolism prophylaxis in bariatric surgery: A best evidence topic.
Khan, OA; Knight, WR; McGlone, ER; Parker, SG; Sufi, P, 2015
)
0.42
"Systemic review, traditional meta-analysis, dose-response meta-analysis and network meta-analysis."( Oral direct factor Xa inhibitor versus enoxaparin for thromboprophylaxis after hip or knee arthroplasty: Systemic review, traditional meta-analysis, dose-response meta-analysis and network meta-analysis.
Chen, M; Chen, S; Deng, Z; Feng, W; Kong, G; Liu, S; Liu, Z; Wang, H; Wu, K; Wu, Y, 2015
)
0.42
" Stata software was used for traditional meta-analysis and dose-response meta-analysis, and Winbugs software was used for network meta-analysis."( Oral direct factor Xa inhibitor versus enoxaparin for thromboprophylaxis after hip or knee arthroplasty: Systemic review, traditional meta-analysis, dose-response meta-analysis and network meta-analysis.
Chen, M; Chen, S; Deng, Z; Feng, W; Kong, G; Liu, S; Liu, Z; Wang, H; Wu, K; Wu, Y, 2015
)
0.42
" Thirty patients undergoing unilateral or bilateral total knee replacement, admitted to the intensive care unit on a therapeutic dosage of subcutaneous enoxaparin (30-mg injections administered twice daily), were included into the study."( Thromboelastography for the monitoring of the antithrombotic effect of low-molecular-weight heparin after major orthopedic surgery.
Kaso, G; Tekkesin, M; Tekkesin, N, 2015
)
0.42
"Ninety-nine morbidly obese patients (body mass index [BMI] higher than 40 kg/m(2) or total body weight more than 150 kg) who received at least three doses of the standard treatment dosage of enoxaparin and had steady-state antifactor Xa peak levels between April 2009 and January 2014."( Monitoring Enoxaparin with Antifactor Xa Levels in Obese Patients.
Ballew, A; Duong, HN; Lee, YR; Vega, JA, 2015
)
0.42
" None of the tests reflecting clot formation rate or stability showed a dose-response to either LMWH but clot lysis showed a tentative negative dose-response to the LMWH's."( Thromboelastometry versus free-oscillation rheometry and enoxaparin versus tinzaparin: an in-vitro study comparing two viscoelastic haemostatic tests' dose-responses to two low molecular weight heparins at the time of withdrawing epidural catheters from t
Larsson, A; Schött, U; Thomas, O; Tynngård, N, 2015
)
0.42
" This casts doubt on the validity of using anti-FXa assays alone to guide dosage of LMWH's."( Thromboelastometry versus free-oscillation rheometry and enoxaparin versus tinzaparin: an in-vitro study comparing two viscoelastic haemostatic tests' dose-responses to two low molecular weight heparins at the time of withdrawing epidural catheters from t
Larsson, A; Schött, U; Thomas, O; Tynngård, N, 2015
)
0.42
"To compare two enoxaparin dosing strategies at achieving prophylactic anti-Xa levels in women with a body mass index (BMI) ⩾35 (kg m(-2)) postcesarean delivery."( A randomized controlled trial of differing doses of postcesarean enoxaparin thromboprophylaxis in obese women.
Caballero, DC; McNulty, J; Neeper, JM; Serra, AE; Stephenson, ML, 2016
)
0.43
"Compared with fixed dosing daily, weight-based dosing twice daily more effectively achieved prophylactic anti-Xa levels without reaching the therapeutic range."( A randomized controlled trial of differing doses of postcesarean enoxaparin thromboprophylaxis in obese women.
Caballero, DC; McNulty, J; Neeper, JM; Serra, AE; Stephenson, ML, 2016
)
0.43
"To investigate the compliance of prescribers with the state-wide Queensland Health (QH) guidelines for dosing and monitoring of enoxaparin, and to examine the effect that compliance has on the patients' length of stay (LOS) in hospital."( Compliance With Enoxaparin Dosing and Monitoring Guidelines and the Impact on Patient Length of Stay: A Pilot Study.
Barras, MA; Dekker, KR; Myers, BL, 2016
)
0.43
" All dosing and monitoring for each patient was compared to the current QH guidelines for enoxaparin usage; a multidisciplinary consensus document."( Compliance With Enoxaparin Dosing and Monitoring Guidelines and the Impact on Patient Length of Stay: A Pilot Study.
Barras, MA; Dekker, KR; Myers, BL, 2016
)
0.43
"This study was conducted to evaluate tinzaparin dosing and therapeutic drug monitoring."( Higher Tinzaparin Dosing Is Needed to Achieve Target Anti-Xa Levels in Pediatric Cardiac Intensive Care Patients.
Bunker-Wiersma, HE; de Wilde, RB; Eikenboom, J; Roeleveld, PP; Smiers, FJ; van der Hoeven, A, 2016
)
0.43
"Target anti-Xa levels were reached with tinzaparin dosing in PICU patients after more than 8 doses, warranting further dose-effect research."( Higher Tinzaparin Dosing Is Needed to Achieve Target Anti-Xa Levels in Pediatric Cardiac Intensive Care Patients.
Bunker-Wiersma, HE; de Wilde, RB; Eikenboom, J; Roeleveld, PP; Smiers, FJ; van der Hoeven, A, 2016
)
0.43
"We report our experience dosing and monitoring enoxaparin with anti-factor Xa activity (anti-FXaA) levels for venous thromboembolism prophylaxis in trauma patients (TP)."( Non-weight-based enoxaparin dosing subtherapeutic in trauma patients.
Beilman, GJ; Chapman, SA; Irwin, ED; Reicks, P, 2016
)
0.43
"TP receiving standard, non-weight-based dosed enoxaparin administered every 12 h for venous thromboembolism prophylaxis with peak anti-FXaA levels measured were prospectively monitored and evaluated and those whose first anti-FXaA levels ≥ or <0."( Non-weight-based enoxaparin dosing subtherapeutic in trauma patients.
Beilman, GJ; Chapman, SA; Irwin, ED; Reicks, P, 2016
)
0.43
"Non-weight-based enoxaparin dosing did not achieve target anti-FXaA levels in most TP."( Non-weight-based enoxaparin dosing subtherapeutic in trauma patients.
Beilman, GJ; Chapman, SA; Irwin, ED; Reicks, P, 2016
)
0.43
" There is limited evidence to support current dosing and monitoring strategies of enoxaparin in this population."( Evaluation of therapeutic enoxaparin in a pregnant population at a tertiary hospital.
Allen, J; Barras, M; Fagermo, N; Lust, K; Martin, JH; Petrie, S, 2016
)
0.43
"Variation exists in dosing and monitoring practices for therapeutic enoxaparin in the pregnant population."( Evaluation of therapeutic enoxaparin in a pregnant population at a tertiary hospital.
Allen, J; Barras, M; Fagermo, N; Lust, K; Martin, JH; Petrie, S, 2016
)
0.43
"Empiric enoxaparin dosing is inadequate for most trauma patients, leading to below target initial anti-Xa levels and requiring dose adjustment for optimal venous thromboembolism prophylaxis."( If some is good, more is better: An enoxaparin dosing strategy to improve pharmacologic venous thromboembolism prophylaxis.
Berndtson, AE; Box, K; Coimbra, R; Costantini, TW; Lane, J, 2016
)
0.43
" Computer modeling was used to select a new dosing protocol, which was implemented on the trauma service as a quality improvement project."( If some is good, more is better: An enoxaparin dosing strategy to improve pharmacologic venous thromboembolism prophylaxis.
Berndtson, AE; Box, K; Coimbra, R; Costantini, TW; Lane, J, 2016
)
0.43
" A new regimen for initial dosing was therefore designed with three weight-defined categories for ease of administration."( If some is good, more is better: An enoxaparin dosing strategy to improve pharmacologic venous thromboembolism prophylaxis.
Berndtson, AE; Box, K; Coimbra, R; Costantini, TW; Lane, J, 2016
)
0.43
" In the patients of both groups the product dabigatran etexilate in the standard dosage (220 mg/day) was used for specific prevention."( [Substantiation of the system of thrombus formation prevention in treatment of patients with hip joint pathology against the background of arterial insufficiency of the lower extremities].
Akhtyamov, IF; Shigaev, ES; Ziatdinov, BG, 2016
)
0.43
" This analysis supports dosing patients with renal impairment in accordance with patients with normal renal function; however, anti-Xa monitoring could be considered to further support safety in selected patients, particularly those with very severe renal impairment."( A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment.
Abreu, P; Feugère, G; Heissler, J; Jen, F; Ruiz, MT; Woodruff, S, 2016
)
0.74
" Standard FDA-approved enoxaparin dosing in this population results in a high incidence of above-goal anti-Xa levels, but its association with bleeding remains unclear."( Evaluation of Enoxaparin Dosing as a Risk Factor for Bleeding in Lung Transplant Recipients.
Bain, KB; Deal, EN; Hachem, RR; Iuppa, JA; Sofjan, AK; Witt, CA; Yusen, RD, 2016
)
0.43
"To evaluate the association between enoxaparin dosing and bleeding in lung transplant recipients and assess the relationship between dosing and anti-Xa levels."( Evaluation of Enoxaparin Dosing as a Risk Factor for Bleeding in Lung Transplant Recipients.
Bain, KB; Deal, EN; Hachem, RR; Iuppa, JA; Sofjan, AK; Witt, CA; Yusen, RD, 2016
)
0.43
" We dichotomized enoxaparin dosing regimens into standard dose (FDA-approved doses with a 10% rounding margin) and reduced dose."( Evaluation of Enoxaparin Dosing as a Risk Factor for Bleeding in Lung Transplant Recipients.
Bain, KB; Deal, EN; Hachem, RR; Iuppa, JA; Sofjan, AK; Witt, CA; Yusen, RD, 2016
)
0.43
" The VTE rate when enoxaparin sodium is dosed by anti-factor Xa (anti-Xa) trough level is not well described."( Association Between Enoxaparin Dosage Adjusted by Anti-Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma.
Barmparas, G; Chung, K; Dhillon, N; Gewertz, BL; Harada, MY; Ko, A; Ley, EJ; Margulies, DR; Mason, R; Yim, DA, 2016
)
0.43
" Trauma patients who received enoxaparin adjusted by anti-Xa trough level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group)."( Association Between Enoxaparin Dosage Adjusted by Anti-Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma.
Barmparas, G; Chung, K; Dhillon, N; Gewertz, BL; Harada, MY; Ko, A; Ley, EJ; Margulies, DR; Mason, R; Yim, DA, 2016
)
0.43
" After providing 3 adjusted doses of enoxaparin, the trough level was redrawn and the dosage was adjusted as necessary."( Association Between Enoxaparin Dosage Adjusted by Anti-Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma.
Barmparas, G; Chung, K; Dhillon, N; Gewertz, BL; Harada, MY; Ko, A; Ley, EJ; Margulies, DR; Mason, R; Yim, DA, 2016
)
0.43
"5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily."( Association Between Enoxaparin Dosage Adjusted by Anti-Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma.
Barmparas, G; Chung, K; Dhillon, N; Gewertz, BL; Harada, MY; Ko, A; Ley, EJ; Margulies, DR; Mason, R; Yim, DA, 2016
)
0.43
" Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding."( Association Between Enoxaparin Dosage Adjusted by Anti-Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma.
Barmparas, G; Chung, K; Dhillon, N; Gewertz, BL; Harada, MY; Ko, A; Ley, EJ; Margulies, DR; Mason, R; Yim, DA, 2016
)
0.43
"To evaluate the effectiveness of TEG-adjusted prophylactic enoxaparin dosing among trauma and surgical patients."( Thrombelastography-Based Dosing of Enoxaparin for Thromboprophylaxis in Trauma and Surgical Patients: A Randomized Clinical Trial.
Arbabi, S; Bulger, EM; Connelly, CR; Erickson, AS; Fair, KA; Hart, KD; Holcomb, JB; Louis, SG; Moore, LJ; Rick, EA; Schreiber, MA; Simeon, EC; Van, PY, 2016
)
0.43
"This randomized clinical trial, conducted from October 2012 to May 2015, compared standard dosing (30 mg twice daily) with TEG-adjusted enoxaparin dosing (35 mg twice daily) for 185 surgical and trauma patients screened for VTE at 3 level I trauma centers in the United States."( Thrombelastography-Based Dosing of Enoxaparin for Thromboprophylaxis in Trauma and Surgical Patients: A Randomized Clinical Trial.
Arbabi, S; Bulger, EM; Connelly, CR; Erickson, AS; Fair, KA; Hart, KD; Holcomb, JB; Louis, SG; Moore, LJ; Rick, EA; Schreiber, MA; Simeon, EC; Van, PY, 2016
)
0.43
" Anti-Xa-guided enoxaparin dosing reduced the rate of DVT from 20."( Anti-Xa-guided enoxaparin thromboprophylaxis reduces rate of deep venous thromboembolism in high-risk trauma patients.
Ginzburg, E; Karcutskie, CA; Lieberman, HM; Lineen, EB; Namias, N; Riggi, G; Singer, GA; Vaghaiwalla, TM, 2016
)
0.43
" Enoxaparin was started at a therapeutic, renally adjusted dosage of 60 mg subcutaneously once daily after the patient's hematomas resolved and hemoglobin level stabilized."( Evidence of a clinically significant interaction between warfarin and intravesical gemcitabine.
Feuz, L; Gee, ME; Krajewski, KC; Kurtzhalts, K, 2016
)
0.43
" Inadequate enoxaparin dosing has been correlated with both asymptomatic and symptomatic VTE events."( Utility of anti-factor Xa monitoring in surgical patients receiving prophylactic doses of enoxaparin for venous thromboembolism prophylaxis.
Pannucci, CJ; Prazak, AM; Scheefer, M, 2017
)
0.46
"Inadequate enoxaparin dosing may explain why some patients have VTE despite enoxaparin prophylaxis."( Utility of anti-factor Xa monitoring in surgical patients receiving prophylactic doses of enoxaparin for venous thromboembolism prophylaxis.
Pannucci, CJ; Prazak, AM; Scheefer, M, 2017
)
0.46
"Compared to enoxaparin (most commonly dosed 40 mg once daily), the relative risk (RR) of VTE was lowest for edoxaban 30 mg once daily (0."( Safety and Efficacy of New Anticoagulants for the Prevention of Venous Thromboembolism After Hip and Knee Arthroplasty: A Meta-Analysis.
Gage, BF; Ganti, BR; Lee, ED; Lin, H; Nunley, RM; Venker, BT, 2017
)
0.46
" Venous thrombosis is frequently treated with low-molecular-weight heparins (LMWHs) such as enoxaparin, but optimal dosing of LMWH must balance the morbidity of venous thrombosis with the potential adverse affects of anticoagulation."( Treatment and follow-up of venous thrombosis in the neonatal intensive care unit: a retrospective study.
Aneja, RK; Bohnhoff, JC; Brozanski, BS; DiSilvio, SA; Domnina, YA; Good, M; Shenk, JR, 2017
)
0.46
"Optimal enoxaparin dosing for deep venous thrombosis (DVT) prophylaxis remains elusive."( Goal directed enoxaparin dosing provides superior chemoprophylaxis against deep vein thrombosis.
Basharat, U; Bogert, JN; Davis, KM; Kopelman, TR; Pieri, PG; Pressman, MA; Quan, AN; Vail, SJ; Walters, JW, 2017
)
0.46
" Goal anti-Xa levels were met initially in only 46% of patients despite dosing of >40mg twice daily in 81% of patients; however, with titration, goal anti-Xa levels were achieved in an additional 109 patients (36%)."( Goal directed enoxaparin dosing provides superior chemoprophylaxis against deep vein thrombosis.
Basharat, U; Bogert, JN; Davis, KM; Kopelman, TR; Pieri, PG; Pressman, MA; Quan, AN; Vail, SJ; Walters, JW, 2017
)
0.46
"To review the evidence regarding increased enoxaparin dosing for venous thromboembolism (VTE) prophylaxis in the general trauma patient population."( Increased Enoxaparin Dosing for Venous Thromboembolism Prophylaxis in General Trauma Patients.
Gales, MA; Horyna, TJ; Sandmann, EA; Walker, CK, 2017
)
0.46
"A total of 7 trials (958 patients) explored the use of increased dosing of enoxaparin for VTE prophylaxis in trauma patients."( Increased Enoxaparin Dosing for Venous Thromboembolism Prophylaxis in General Trauma Patients.
Gales, MA; Horyna, TJ; Sandmann, EA; Walker, CK, 2017
)
0.46
" Weight-based enoxaparin dosing (0."( Increased Enoxaparin Dosing for Venous Thromboembolism Prophylaxis in General Trauma Patients.
Gales, MA; Horyna, TJ; Sandmann, EA; Walker, CK, 2017
)
0.46
"The APEX trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among hospitalized, acutely ill medical patients."( The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial.
Arbetter, DF; Bandman, O; Cohen, AT; Daaboul, Y; Gibson, CM; Gold, A; Goldhaber, SZ; Halaby, R; Harrington, RA; Hernandez, AF; Hull, R; Korjian, S; Leeds, JM; Lu, SP; Yee, MK, 2017
)
0.46
"Adherence to FDA-approved dosing for the direct oral anticoagulants (DOACs) based on renal function, hepatic function, and concomitant medications in a real-world setting has not been evaluated."( Appropriateness of direct oral anticoagulant dosing for venous thromboembolism treatment.
Bohm, N; Duckett, A; Fisher, S; Tran, E, 2017
)
0.46
"The current debate over the optimal Enoxaparin prophylactic dosing strategies in obese patients centre around whether it should be based on the actual weight of the patient (i."( Review of current evidence available for guiding optimal Enoxaparin prophylactic dosing strategies in obese patients-Actual Weight-based vs Fixed.
Ball, P; He, Z; Morrissey, H, 2017
)
0.46
"The aim of the parent study is to compare the clinical outcomes for obese patients who received fixed doses of enoxaparin compared to those who received weight-based doses within the licensed dosage recommendations."( Review of current evidence available for guiding optimal Enoxaparin prophylactic dosing strategies in obese patients-Actual Weight-based vs Fixed.
Ball, P; He, Z; Morrissey, H, 2017
)
0.46
"Pooled data from the eleven studies suggested that weight-based or higher-than-fixed dosing had a 36."( Review of current evidence available for guiding optimal Enoxaparin prophylactic dosing strategies in obese patients-Actual Weight-based vs Fixed.
Ball, P; He, Z; Morrissey, H, 2017
)
0.46
" Further research is required to compare long-term outcomes after fixed and weight-based dosing of enoxaparin."( Review of current evidence available for guiding optimal Enoxaparin prophylactic dosing strategies in obese patients-Actual Weight-based vs Fixed.
Ball, P; He, Z; Morrissey, H, 2017
)
0.46
"Stable CVST may be treated with UFH infusion; however, there is limited literature that describes UFH dosing for CVST management."( Pharmacological management of cerebral venous sinus thrombosis with full-dose IV heparin infusion and its clinical outcomes.
Fernandez, A; Ho, J; Mckeone, A; Nair, V, 2017
)
0.46
" Once-daily dosing was associated with a lower bleeding risk as compared with twice-daily."( Major bleeding risks of different low-molecular-weight heparin agents: a cohort study in 12 934 patients treated for acute venous thrombosis.
Biedermann, JS; Cannegieter, SC; Kruip, MJHA; Lijfering, WM; Reitsma, PH; van der Meer, FJM; van Rein, N; Vermaas, HW; Wiersma, N, 2017
)
0.46
" Objectives To determine major bleeding risks for different LMWH agents and dosing schedules."( Major bleeding risks of different low-molecular-weight heparin agents: a cohort study in 12 934 patients treated for acute venous thrombosis.
Biedermann, JS; Cannegieter, SC; Kruip, MJHA; Lijfering, WM; Reitsma, PH; van der Meer, FJM; van Rein, N; Vermaas, HW; Wiersma, N, 2017
)
0.46
"National guidelines have been developed to ensure correct dosing of tinzaparin for women delivered by caesarean delivery (CD) to reduce the risk of venous thromboembolism."( Tinzaparin thromboprophylaxis prescribing practice after caesarean delivery 2009-2014.
Maguire, PJ; McGuire, M; McNicholl, M; Power, KA; Sheehan, SR; Turner, MJ, 2018
)
0.48
" Nanocomplexes (NCs) for the controlled delivery of the antithrombotic Enoxaparin (Enox) with dextran sulfate (DS) and chitosan (CS) were formulated, in an attempt to circumvent therapeutic and compliance challenges associated with the prolonged administration of the current dosage form."( Polysaccharides-based nanocomplexes for the prolonged delivery of enoxaparin: In-vitro and in-vivo evaluation.
Awad, GAS; Geneidi, AS; Ibrahim, SS; Mortada, ND; Osman, R, 2017
)
0.46
"Individualised drug dosing has been shown to improve patient outcomes and reduce adverse drug events."( Individualised medicine: why we need Bayesian dosing.
Barras, MA; Donagher, J; Martin, JH, 2017
)
0.46
" Although low-molecular-weight heparin (LMWH) is recommended in CVT, the specific type and dosage regimen of LMWH have never been specifically suggested."( Comparison of the efficacy of fixed-dose enoxaparin and adjusted-dose unfractionated heparin in patients with cerebral venous thrombosis.
Korathanakhun, P; Petpichetchian, C; Petpichetchian, W; Sathirapanya, P, 2017
)
0.46
"A case highlighting challenges with enoxaparin dosage and monitoring in obese patients is presented."( Treatment of suspected pulmonary embolism in a morbidly obese patient.
Borgstadt, MB; Carlson, L; Heitlage, V, 2017
)
0.46
" However, several international guidelines recommend the same preemptive dosage reduction for all therapeutic dose LMWHs prescribed in renal insufficient patients, to ensure that there is no accumulation of anticoagulant activity and increased risk of bleeding."( Empirically Reduced Dosages of Tinzaparin in Patients with Moderate-to-Severe Renal Insufficiency Lead to Inadequate Anti-Xa Levels.
Henskens, YMC; Meertens, NEL; Olie, RH; Ten Cate, H, 2017
)
0.46
"In renal insufficient patients, the preemptive dosage reduction of tinzaparin leads to inadequate anti-Xa levels."( Empirically Reduced Dosages of Tinzaparin in Patients with Moderate-to-Severe Renal Insufficiency Lead to Inadequate Anti-Xa Levels.
Henskens, YMC; Meertens, NEL; Olie, RH; Ten Cate, H, 2017
)
0.46
" As inadequate dosing may result in thrombosis or bleeding, a clinical need exists for a suitable test."( An Evaluation of a Factor Xa-Based Clotting Time Test for Enoxaparin: A Proof-of-Concept Study.
Duffull, SB; Faed, JM; Gulati, A; Isbister, GK; Ng, DPJ, 2018
)
0.48
" Real-time enoxaparin dose adjustment significantly increased the proportion of patients who achieved in-range peak aFXa levels, compared to standard dosing (74."( Anti-Factor Xa measurements in acute care surgery patients to examine enoxaparin dose.
Fleming, KI; Lonardo, N; Nirula, R; Nunez, J; Pannucci, CJ; Shipley, RW; Tonna, JE; Wall, V, 2018
)
0.48
" The risk of under dosing seems less predictable; therefore, anti-Xa assay may be useful in severe clinical situations that require higher anticoagulant activity."( Can we reliably predict the level of anticoagulation after enoxaparin injection in elderly patients with renal failure?
Corrà, L; Di Francesco, V; Facchinetti, R; Fantin, F; Fontana, G; Pellizzari, L; Sepe, A; Zamboni, M, 2018
)
0.48
" Data regarding the appropriate dosing strategy in this special population is limited."( Anti-factor Xa levels in patients undergoing laparoscopic sleeve gastrectomy: 2 different dosing regimens of enoxaparin.
Eldar, SM; Gelikas, S; Lahat, G, 2017
)
0.46
"To evaluate 2 different dosing regimens of enoxaparin in a prospective cohort of patients undergoing laparoscopic sleeve gastrectomy."( Anti-factor Xa levels in patients undergoing laparoscopic sleeve gastrectomy: 2 different dosing regimens of enoxaparin.
Eldar, SM; Gelikas, S; Lahat, G, 2017
)
0.46
"In the absence of sufficient data regarding clinical efficacy and safety of different dosing regimens both dosing regimens studied are reasonable choices for venous thromboembolic events prophylaxis after bariatric surgery."( Anti-factor Xa levels in patients undergoing laparoscopic sleeve gastrectomy: 2 different dosing regimens of enoxaparin.
Eldar, SM; Gelikas, S; Lahat, G, 2017
)
0.46
"Enoxaparin dosing requirements in the first year of life can be highly variable."( Enoxaparin Population Pharmacokinetics in the First Year of Life.
Galati, M; Lee-Kim, Y; Mahoney, D; Moffett, BS; Shah, MD; Teruya, J; Yee, DL, 2017
)
0.46
" When evaluated graphically, dosing based on PMA appeared to have less variability as compared to postnatal age-based dosing."( Enoxaparin Population Pharmacokinetics in the First Year of Life.
Galati, M; Lee-Kim, Y; Mahoney, D; Moffett, BS; Shah, MD; Teruya, J; Yee, DL, 2017
)
0.46
"Pediatric patients should initially be dosed at 1-mg/kg/dose subcutaneously every 12 hours for treatment of thromboembolism followed by anti-Xa activity monitoring."( Population Pharmacokinetics of Enoxaparin in Pediatric Patients.
Galati, M; Lee-Kim, Y; Mahoney, D; Moffett, BS; Shah, MD; Teruya, J; Yee, D, 2018
)
0.48
"Essentials The once-daily dosing of tinzaparin provides an advantage over other low molecular weight heparins."( Evaluation of the age-dependent dosing recommendations for the administration of daily tinzaparin in children with thrombosis.
Avery, P; Biss, TT; Murphy, P; Musgrave, KM; Webber, K, 2017
)
0.46
" There are few data to support the efficacy and safety of once-daily tinzaparin dosing in children with thrombosis."( Evaluation of the age-dependent dosing recommendations for the administration of daily tinzaparin in children with thrombosis.
Avery, P; Biss, TT; Murphy, P; Musgrave, KM; Webber, K, 2017
)
0.46
"The efficacy of anti-factor Xa (anti-Xa)-guided dosing of thromboprophylaxis after trauma remains controversial."( Association of Anti-Factor Xa-Guided Dosing of Enoxaparin With Venous Thromboembolism After Trauma.
Dharmaraja, A; Eidelson, SA; Karcutskie, CA; Lama, G; Lineen, EB; Martin, AG; Namias, N; Padiadpu, AB; Patel, J; Proctor, KG; Schulman, CI, 2018
)
0.48
"To assess whether dosing of enoxaparin sodium based on peak anti-Xa levels is associated with the venous thromboembolism (VTE) rate after trauma."( Association of Anti-Factor Xa-Guided Dosing of Enoxaparin With Venous Thromboembolism After Trauma.
Dharmaraja, A; Eidelson, SA; Karcutskie, CA; Lama, G; Lineen, EB; Martin, AG; Namias, N; Padiadpu, AB; Patel, J; Proctor, KG; Schulman, CI, 2018
)
0.48
"No previous studies have established the optimal antifactor Xa (anti-Xa) level to guide thromboprophylaxis (TPX) dosing with enoxaparin in trauma patients."( Relation of antifactor-Xa peak levels and venous thromboembolism after trauma.
Dharmaraja, A; Eidelson, SA; Karcutskie, CA; Lineen, EB; Martin, AG; Namias, N; Patel, J; Proctor, KG; Schulman, CI, 2017
)
0.46
" Furthermore, these levels were never achieved in some trauma patients despite repeated dosing over a >10-day period."( Relation of antifactor-Xa peak levels and venous thromboembolism after trauma.
Dharmaraja, A; Eidelson, SA; Karcutskie, CA; Lineen, EB; Martin, AG; Namias, N; Patel, J; Proctor, KG; Schulman, CI, 2017
)
0.46
" There is limited data comparing anticoagulation efficacy between subtypes of LMWH and dosing regimens in this context."( Mechanical Mitral Valve Thrombosis Secondary to Tinzaparin as an Anticoagulation Bridging Strategy.
Harten, C; Kent, WDT; Vasanthan, V, 2018
)
0.48
" We sought to investigate if prophylactic enoxaparin dosed by anti-Xa trough levels could reduce clinically evident VTE in trauma patients with lower extremity or pelvic injury."( Trauma patients with lower extremity and pelvic fractures: Should anti-factor Xa trough level guide prophylactic enoxaparin dose?
Barmparas, G; Dhillon, NK; Gewertz, BL; Gillette, E; Ley, EJ; Mason, R; Smith, EJT, 2018
)
0.48
"1 IU/mL or lower had their dosage increased by 10-mg increments."( Trauma patients with lower extremity and pelvic fractures: Should anti-factor Xa trough level guide prophylactic enoxaparin dose?
Barmparas, G; Dhillon, NK; Gewertz, BL; Gillette, E; Ley, EJ; Mason, R; Smith, EJT, 2018
)
0.48
" Initial enoxaparin dosing in the majority of patients (84."( Trauma patients with lower extremity and pelvic fractures: Should anti-factor Xa trough level guide prophylactic enoxaparin dose?
Barmparas, G; Dhillon, NK; Gewertz, BL; Gillette, E; Ley, EJ; Mason, R; Smith, EJT, 2018
)
0.48
" We aimed to determine whether current enoxaparin dosing regimens effectively achieve anti-factor Xa concentrations within prophylactic goal ranges in this patient population."( Establishment of prophylactic enoxaparin dosing recommendations to achieve targeted anti-factor Xa concentrations in children with CHD.
Israel, EN; Mastropietro, CW; Thomas, CA, 2018
)
0.48
"Enoxaparin doses required to achieve prophylactic anti-factor Xa concentrations in young children with CHD were consistently higher than the currently recommended prophylactic dosing regimens."( Establishment of prophylactic enoxaparin dosing recommendations to achieve targeted anti-factor Xa concentrations in children with CHD.
Israel, EN; Mastropietro, CW; Thomas, CA, 2018
)
0.48
" Future research should examine the impact of weight-based once daily enoxaparin dosing versus twice daily enoxaparin dosing on prophylaxis adequacy."( Enoxaparin 40 mg per Day Is Inadequate for Venous Thromboembolism Prophylaxis After Thoracic Surgical Procedure.
Fleming, KI; Holoyda, K; Moulton, L; Pannucci, CJ; Prazak, AM; Varghese, TK, 2018
)
0.48
" Weight-based twice-daily enoxaparin dosing may optimize the risks and benefits of prophylactic anticoagulation after plastic and reconstructive surgery."( The Impact of Once- versus Twice-Daily Enoxaparin Prophylaxis on Risk for Venous Thromboembolism and Clinically Relevant Bleeding.
Agarwal, J; Fleming, KI; Momeni, A; Pannucci, CJ; Prazak, AM; Rockwell, WB, 2018
)
0.48
"Despite the increasing numbers of obese patients undergoing elective surgery, there is a lack of evidence-based dosing guidelines for peri-operative medications in obesity."( Peri-operative Medication Dosing in Adult Obese Elective Surgical Patients: A Systematic Review of Clinical Studies.
Curtain, C; Hussain, Z; Mirkazemi, C; Zaidi, STR, 2018
)
0.48
"The objective was to systematically review the dosing and outcomes of peri-operative medications used in obese elective surgical patients."( Peri-operative Medication Dosing in Adult Obese Elective Surgical Patients: A Systematic Review of Clinical Studies.
Curtain, C; Hussain, Z; Mirkazemi, C; Zaidi, STR, 2018
)
0.48
" Studies of medications in obese surgical patients were included if they had a non-obese control or comparative dosing scalar group."( Peri-operative Medication Dosing in Adult Obese Elective Surgical Patients: A Systematic Review of Clinical Studies.
Curtain, C; Hussain, Z; Mirkazemi, C; Zaidi, STR, 2018
)
0.48
" Ideal body weight was reported as an appropriate dosing scalar for non-depolarizing muscle relaxants and neuromuscular reversal agents."( Peri-operative Medication Dosing in Adult Obese Elective Surgical Patients: A Systematic Review of Clinical Studies.
Curtain, C; Hussain, Z; Mirkazemi, C; Zaidi, STR, 2018
)
0.48
" An enoxaparin venous thromboembolism (VTE) prophylaxis protocol implemented in October 2015 provided weight-adjusted initial dosing parameters with subsequent dose titration to achieve targeted anti-factor Xa levels."( Improving Pharmacologic Prevention of VTE in Trauma: IMPACT-IT QI Project.
Adams, E; Bethea, A; Chumbe, JT; Lucente, FC; Samanta, D, 2018
)
0.48
"Standard low-molecular-weight heparin dosing may be suboptimal for venous thromboembolism prophylaxis."( Inability to predict subprophylactic anti-factor Xa levels in trauma patients receiving early low-molecular-weight heparin.
Clark, AT; Cripps, MW; Cunningham, HB; Eastman, AL; Huang, E; Imran, JB; Kacir, CD; Koshy, JP; Madni, TD; Minshall, CT; Rizk, P; Taveras, LR, 2018
)
0.48
" Of the subXa cohort, 35 (92%) had their dosage increased, and the repeat Xa testing that was done in 32 revealed that only 75% reached prophylactic levels."( Inability to predict subprophylactic anti-factor Xa levels in trauma patients receiving early low-molecular-weight heparin.
Clark, AT; Cripps, MW; Cunningham, HB; Eastman, AL; Huang, E; Imran, JB; Kacir, CD; Koshy, JP; Madni, TD; Minshall, CT; Rizk, P; Taveras, LR, 2018
)
0.48
" Intrinsic factors may prevent adequate prophylaxis even with earlier administration and higher dosing of low-molecular-weight heparin."( Inability to predict subprophylactic anti-factor Xa levels in trauma patients receiving early low-molecular-weight heparin.
Clark, AT; Cripps, MW; Cunningham, HB; Eastman, AL; Huang, E; Imran, JB; Kacir, CD; Koshy, JP; Madni, TD; Minshall, CT; Rizk, P; Taveras, LR, 2018
)
0.48
" We describe the first case report, to our knowledge, of a severely burned patient who, despite prophylactic dosing of enoxaparin 30 mg subcutaneously twice daily, developed an acute DVT that required high-dose enoxaparin (100 mg [1."( Increased Enoxaparin Dosing Requirements for Treatment of Deep Vein Thrombosis in a Severely Burned Patient: Case Report and Literature Review.
Haan, BJ; Mangan, KC; Yost, RJ, 2018
)
0.48
" Potential determinants of dalteparin dosing were assessed."( Dalteparin anticoagulation in paediatric home haemodialysis.
Hothi, DK; Lutkin, M; Stronach, L; Yadav, P, 2018
)
2.22
" Factors associated with higher dalteparin dosing requirements included a younger age of the child (p < 0."( Dalteparin anticoagulation in paediatric home haemodialysis.
Hothi, DK; Lutkin, M; Stronach, L; Yadav, P, 2018
)
2.21
" We used American College of Obstetrics and Gynecology recommendations as the base for screening and dosing guidelines and utilized known and published absolute risk values and odds ratios to stratify risk factors."( Risk Assessment and Treatment Guide for Obstetric Thromboprophylaxis: Comprehensive Review of Current Guidelines.
Deering, SH; Eubanks, AA; Thiel, LM, 2019
)
0.51
"Enoxaparin is commonly used in the prevention of renal allograft vascular thrombosis but off-label in children, and no consensus exists regarding the optimal dosing and dose adjustment."( Pharmacokinetics of Enoxaparin After Renal Transplantation in Pediatric Patients.
Borgel, D; Boyer, O; Charbit, M; Damamme, A; Krid, S; Krug, P; Lasne, D; Salomon, R; Treluyer, JM; Urien, S, 2018
)
0.48
" With the availability of anti-Xa assays, future reversal recommendations of enoxaparin associated bleeds using protamine sulfate should include the initial anti-Xa assay as a guide for the dosing regimen."( Protamine sulfate for the reversal of enoxaparin associated hemorrhage beyond 12 h.
Adamski, JH; Barcelona, RA; Gibbons, J; Janko, MR; Lauer, BR; Nelson, RA; Ravi, G, 2019
)
0.51
"A systematic review of studies published between 1 January 1985 and 31 August 2017 was performed to analyse the efficacy of the low-molecular-weight heparin, dalteparin, in venous thromboembolism (VTE) treatment and prophylaxis during pregnancy, and to evaluate dosing practices, anticoagulant monitoring and adverse events."( Obstetric venous thromboembolism: a systematic review of dalteparin and pregnancy.
Hellgren, M; Mistafa, O, 2019
)
0.96
" If possible, enoxaparin is started, with dosing twice a day."( Significant Reduction of Pulmonary Embolism in Orthopaedic Trauma Patients.
Au, B; Cripps, MW; Eastman, A; Gebrelul, A; Hu, G; Minei, J; Sanders, D; Sathy, A; Shirley, Z; Starr, AJ; Sutphin, PD, 2019
)
0.51
"4 ml was started subcutaneously after the PCD was removed from the patient and the same dosage of nadroparin was given daily for 15 days following the bariatric operation."( A New Protocol for Venous Thromboembolism Prophylaxis in Bariatric Surgery.
Abuoglu, HH; Müftüoğlu, MAT; Odabaşı, M, 2019
)
0.51
"Low dosage LMWH with PCD is very effective for VTE prophylaxis in bariatric surgery."( A New Protocol for Venous Thromboembolism Prophylaxis in Bariatric Surgery.
Abuoglu, HH; Müftüoğlu, MAT; Odabaşı, M, 2019
)
0.51
"Enoxaparin dosing recommendations for morbidly obese patients are lacking."( Evaluation of Treatment-Dose Enoxaparin in Acutely Ill Morbidly Obese Patients at an Academic Medical Center: A Randomized Clinical Trial.
Alexander, BR; Curry, MA; Evans, KS; Kempton, CL; LaFollette, JA; Tran, RH, 2019
)
0.51
"4% dosing rivaroxaban by Biophen DIXaI vs 583."( An in vitro study to investigate the interference of enoxaparin on plasma levels of direct oral factor Xa inhibitors measured by chromogenic assays.
Cini, M; Cosmi, B; Legnani, C; Palareti, G; Testa, S; Tripodi, A, 2019
)
0.51
" While 30-mg twice-daily enoxaparin is accepted as the standard prophylactic dose, recent evidence in injured patients suggests this dosing strategy may result in sub-optimal pharmacologic DVT prophylaxis."( Anti-Xa guided enoxaparin dose adjustment improves pharmacologic deep venous thrombosis prophylaxis in burn patients.
Berndtson, AE; Box, K; Costantini, TW; Cronin, BJ; Godat, LN; Kolan, S; Lee, JG; Pham, A, 2019
)
0.51
" Alternate dosing strategies should be considered to increase the number of burn patients achieving target prophylactic anti-Xa levels."( Anti-Xa guided enoxaparin dose adjustment improves pharmacologic deep venous thrombosis prophylaxis in burn patients.
Berndtson, AE; Box, K; Costantini, TW; Cronin, BJ; Godat, LN; Kolan, S; Lee, JG; Pham, A, 2019
)
0.51
" Due to the expense associated with ATIII, a capped dosing approach for ATIII was evaluated in this population."( Capped antithrombin III dosing is cost effective in the management of asparaginase-associated thrombosis.
Breese, EH; Jenkins, M; Luchtman-Jones, L; O'Brien, M; Sawyer, J; Young, J, 2019
)
0.51
"Current treatment dose of enoxaparin is based on total body weight (TBW), however dosage in obesity remains unclear."( Evaluation of weight based enoxaparin dosing on anti-Xa concentrations in patients with obesity.
Barras, M; van Oosterom, N; Winckel, K, 2019
)
0.51
"Thromboprophylaxis dosing strategies using enoxaparin in elderly patients with renal disease are limited, while dose adjustments or monitoring of anti-Xa levels are recommended."( Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment.
Chamoun, N; Dimassi, H; Ghanem, G; Ghanem, H; Hachem, A; Hariri, E; Lteif, C; Mansour, H; Zalloum, R, 2019
)
0.51
" However, fixed prophylactic doses of enoxaparin in low-weight patients may be close to the weight-based dosing recommended for VTE treatment."( Enoxaparin Thromboprophylaxis Dosing and Anti-Factor Xa Levels in Low-Weight Patients.
Bahjri, K; Cotton, A; Geslani, V; Hong, L; Yam, L, 2019
)
0.51
" There appears to be no safety concerns with reduced enoxaparin dosing in low-weight patients."( Enoxaparin Thromboprophylaxis Dosing and Anti-Factor Xa Levels in Low-Weight Patients.
Bahjri, K; Cotton, A; Geslani, V; Hong, L; Yam, L, 2019
)
0.51
" Patients were significantly more likely to achieve an in-range peak aFXa with real-time dose adjustment as opposed to fixed dosing alone (85."( Assessment of Anti-Factor Xa Levels of Patients Undergoing Colorectal Surgery Given Once-Daily Enoxaparin Prophylaxis: A Clinical Study Examining Enoxaparin Pharmacokinetics.
Bertolaccini, CB; Fleming, KI; Huang, LC; Pannucci, CJ; Pickron, TB; Prazak, AM, 2019
)
0.51
"The study analyzes the effectiveness and safety of a higher than standard enoxaparin dosing protocol implemented for pediatric patients requiring initiation of therapeutic anticoagulation."( Retrospective comparison of two enoxaparin dosing and monitoring protocols at a pediatric hospital.
Anderson, CR; Boehme, S; Olson, JA; Wilcox, RA; Wolsey, A, 2019
)
0.51
"A retrospective review of 2 enoxaparin dosing and monitoring protocols was performed."( Retrospective comparison of two enoxaparin dosing and monitoring protocols at a pediatric hospital.
Anderson, CR; Boehme, S; Olson, JA; Wilcox, RA; Wolsey, A, 2019
)
0.51
"Initiating enoxaparin at higher doses in pediatric patients may result in fewer dosing changes than standard dosing."( Retrospective comparison of two enoxaparin dosing and monitoring protocols at a pediatric hospital.
Anderson, CR; Boehme, S; Olson, JA; Wilcox, RA; Wolsey, A, 2019
)
0.51
" We hypothesized that weight-based dosing would result in appropriate prophylaxis more reliably than fixed dosing."( Weight-based enoxaparin with anti-factor Xa assay-based dose adjustment for venous thromboembolic event prophylaxis in adult trauma patients results in improved prophylactic range targeting.
Ayoung-Chee, P; Bukur, M; DiMaggio, CJ; Frangos, SG; Marshall, GT; Moore, S; Rodier, SG; Tandon, M, 2021
)
0.62
"Weight-based VTE prophylaxis with anti-Xa-based dose adjustment improves prophylactic range targeting relative to uniform dosing and eliminates variances secondary to BSA and weight in trauma patients."( Weight-based enoxaparin with anti-factor Xa assay-based dose adjustment for venous thromboembolic event prophylaxis in adult trauma patients results in improved prophylactic range targeting.
Ayoung-Chee, P; Bukur, M; DiMaggio, CJ; Frangos, SG; Marshall, GT; Moore, S; Rodier, SG; Tandon, M, 2021
)
0.62
" Enoxaparin dosing and corresponding anti-factor Xa levels were collected."( Evaluation of the Efficacy of Enoxaparin in the Neonatal Intensive Care Unit.
Abdel-Rasoul, M; Magers, J; Prusakov, P; Song, D, 2021
)
0.62
" Standard prophylactic enoxaparin dosing was 40 mg SC daily, unless amended by the treating clinician."( The ATLANTIC study: Anti-Xa level assessment in trauma intensive care.
Fitzgerald, M; Martin, EL; Rakhra, S; Udy, A, 2020
)
0.56
" The purpose of this study was to assess the impact of the route of administration and dosage regimen on the compliance to the prescription."( Extended thromboprophylaxis for hip or knee arthroplasty. Does the administration route and dosage regimen affect adherence? A cohort study.
Bautista, M; Bonilla, G; Castro, J; Llinás, A; Moreno, JP, 2020
)
0.56
" Incidence of in-hospital VTE and major bleeding after changes in enoxaparin dosing were monitored."( Prophylactic Enoxaparin Adjusted by Anti-Factor Xa Peak Levels Compared with Recommended Thromboprophylaxis and Rates of Clinically Evident Venous Thromboembolism in Surgical Oncology Patients.
Kramme, K; Munene, G; Sarraf, P, 2020
)
0.56
" Various prophylaxis dosing strategies have been investigated."( Safety and Efficacy of High-Dose Unfractionated Heparin Versus High-Dose Enoxaparin for Venous Thromboembolism Prevention in Morbidly Obese Hospitalized Patients.
Barber, A; Chen, SL; Jones, E; Mason, SW; Moll, S; Northam, K, 2020
)
0.56
" Racial differences in pharmacokinetics, dosing requirements, drug response, and/or safety end points were identified for unfractionated heparin, enoxaparin, argatroban, warfarin, rivaroxaban, and edoxaban."( Racial and Ethnic Differences in Response to Anticoagulation: A Review of the Literature.
Gibson, CM; Yuet, WC, 2021
)
0.62
" The patient developed a left thigh hematoma requiring surgical evacuation 1 month after initiation of weight-based dosing of enoxaparin."( Successful Long-term Anticoagulation with Enoxaparin in a Patient with a Mechanical Heart Valve.
Bathini, VG; Korapati, S; Mathew, C; Wang, X, 2020
)
0.56
" Here we describe the results of 3 studies that evaluated the safety and tolerability of DS-1040 along with the effect on DS-1040 pharmacokinetic (PK) parameters, when dosed alone or when coadministered with aspirin (NCT02071004), clopidogrel (NCT02560688), or enoxaparin in healthy subjects."( Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin.
Dishy, V; Kobayashi, F; Kochan, J; Limsakun, T; McPhillips, P; Mendell, J; Orihashi, Y; Pav, J; Pizzagalli, F; Rambaran, C; Vandell, AG; Warren, V; Zhou, J, 2020
)
0.56
" More studies are needed on the prophylactic use and dosing of enoxaparin in patients undergoing LAGB procedures to provide high-level evidence."( Risk of venous thromboembolism, use of enoxaparin and clinical outcomes in obese patients undergoing laparoscopic adjustable gastric band surgery: A retrospective study.
Curtain, C; Hussain, Z; Mirkazemi, C; Peterson, GM; Zaidi, STR, 2020
)
0.56
"This study evaluated the safety of early anti-factor Xa assay-guided enoxaparin dosing for chemoprophylaxis in patients with TBI."( Early Anti-Xa Assay-Guided Low Molecular Weight Heparin Chemoprophylaxis Is Safe in Adult Patients with Acute Traumatic Brain Injury.
Berry, CD; Bukur, M; DiMaggio, CJ; Frangos, SG; Huang, PP; Kim, M; Klein, MJ; Moore, S; Rodier, SG; Tandon, M, 2020
)
0.56
"To determine whether the presence of multiple renal clearance estimates affects pharmacist drug dosing decisions."( The Impact of Multiple Renal Estimates on Pharmacist Dosing Recommendations: A Randomized Trial.
Hanni, CM; McConachie, SM; Mohammad, RA; Raub, JN; Wilhelm, SM, 2021
)
0.62
" Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54."( The Impact of Multiple Renal Estimates on Pharmacist Dosing Recommendations: A Randomized Trial.
Hanni, CM; McConachie, SM; Mohammad, RA; Raub, JN; Wilhelm, SM, 2021
)
0.62
"Pharmacists provided with a single renal clearance estimate were more likely to adhere to approved dosing recommendations than pharmacists provided with multiple estimates."( The Impact of Multiple Renal Estimates on Pharmacist Dosing Recommendations: A Randomized Trial.
Hanni, CM; McConachie, SM; Mohammad, RA; Raub, JN; Wilhelm, SM, 2021
)
0.62
"Empirically dosed enoxaparin is routinely given in the postoperative period for venous thromboembolism (VTE) prophylaxis after radical cystectomy (RC)."( Rethinking the one-size-fits-most approach to venous thromboembolism prophylaxis after radical cystectomy.
Ambani, SN; Corona, LE; Hafez, K; Herrel, LA; Kaffenberger, SD; Montgomery, JS; Morgan, TM; Qin, Y; Singhal, U; Weizer, AZ, 2020
)
0.56
"Higher body mass index was associated with subprophylactic enoxaparin dosing after RC."( Rethinking the one-size-fits-most approach to venous thromboembolism prophylaxis after radical cystectomy.
Ambani, SN; Corona, LE; Hafez, K; Herrel, LA; Kaffenberger, SD; Montgomery, JS; Morgan, TM; Qin, Y; Singhal, U; Weizer, AZ, 2020
)
0.56
" Given the favourable safety profile of NOACs (especially if a reduced dosage of Apixaban or Rivaroxaban is initiated after at least six months of therapeutic anticoagulation), extended oral anticoagulation of indefinite duration should be considered for all patients with intermediate risk of recurrence."( [Antithrombotic Treatment of Pulmonary Embolism].
Ebner, M; Lankeit, M, 2020
)
0.56
" An antithrombotic prophylaxis at low dosage was immediately started, then increased at prophylactic dosage."( How haemophilia A impacts severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) treatment: a case report.
Campello, E; Pasca, S; Simioni, P; Spiezia, L; Vettor, R; Zanon, E, 2020
)
0.56
"Patients with RI treated with dalteparin face a higher risk of bleeding than those with NRF, which seems to make it necessary to monitor and seek new dosage adjustments for these patients."( Haemorrhagic complications in patients with renal insufficiency during treatment or prophylaxis with dalteparin.
Corregidor Luna, L; Díaz Gómez, E; García Díaz, B; Iglesias-Peinado, I; Suárez Del Olmo, D, 2022
)
1.23
"Appropriate dosing of therapeutic anticoagulation during periods of thrombocytopenia remains uncertain for patients undergoing hematopoietic stem cell transplants (HSCT)."( Outcomes with enoxaparin dose reductions during thrombocytopenia in patients with hematopoietic stem cell transplantation (HSCT).
Lam, J; Luk, SO; Tavares, E, 2021
)
0.62
" There is no standard venous thromboembolism (VTE) prophylaxis for both dosing and duration of anticoagulation following laparoscopic sleeve gastrectomy."( Adding a Preoperative Dose of LMWH may Decrease VTE Following Bariatric Surgery.
Abdelsalam, AM; Aisha, HAA; ElAnsary, AMSE; Elfergany, HM; Nassef, SA; Salman, MA, 2021
)
0.62
"The aim of this study was to evaluate the adequacy of prophylactic dosing of enoxaparin in patients with severe obesity by performing an antifactor Xa (AFXa) assay."( Assessment of empiric body mass index-based thromboprophylactic dosing of enoxaparin after bariatric surgery: evidence for dosage adjustment using anti-factor Xa in high-risk patients.
Aminian, A; Brethauer, SA; Cetin, D; Daigle, CR; Karas, LA; Nor Hanipah, Z; Schauer, PR, 2021
)
0.62
"BMI-based thromboprophylactic dosing of enoxaparin after bariatric surgery could be suboptimal in 15% of patients with obesity."( Assessment of empiric body mass index-based thromboprophylactic dosing of enoxaparin after bariatric surgery: evidence for dosage adjustment using anti-factor Xa in high-risk patients.
Aminian, A; Brethauer, SA; Cetin, D; Daigle, CR; Karas, LA; Nor Hanipah, Z; Schauer, PR, 2021
)
0.62
"This manuscript establishes inadequate enoxaparin dosing as a plausible mechanism for breakthrough VTE in surgical patients, and identifies anticoagulant dose adequacy as a novel target for process improvement measures."( Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials.
Bertolaccini, C; Fleming, KI; Huang, LC; Momeni, A; Pannucci, CJ; Pickron, TB; Prazak, AM; Stringham, J; Varghese, TK, 2022
)
0.72
" Enoxaparin dosing was nearly double the recommended starting doses for secondary thromboprophylaxis."( Thromboprophylaxis in congenital nephrotic syndrome: 15-year experience from a national cohort.
Dobbie, LJ; Eskell, L; Lamb, A; Ramage, IJ; Reynolds, BC, 2021
)
0.62
" The purpose of the study was to evaluate the association between initial dosing strategy of thromboprophylaxis in critically ill COVID-19 patients and the risk of death, thromboembolism, and bleeding."( Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients.
Cronhjort, M; Dahlberg, M; Everhov, ÅH; Grip, J; Günther, M; Hollenberg, J; Järnbert-Pettersson, H; Jonmarker, S; Litorell, J; Schandl, A; Söderberg, M; Stackelberg, O, 2020
)
0.56
" Thromboprophylaxis dosage was based on local standardized recommendations, not on degree of critical illness or risk of thrombosis."( Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients.
Cronhjort, M; Dahlberg, M; Everhov, ÅH; Grip, J; Günther, M; Hollenberg, J; Järnbert-Pettersson, H; Jonmarker, S; Litorell, J; Schandl, A; Söderberg, M; Stackelberg, O, 2020
)
0.56
" Joseph's Healthcare Hamilton utilizes a weight-adjusted tinzaparin dosage (50 to 75 units/kg rounded to nearest pre-filled syringe) for postoperative VTE prophylaxis."( Weight-adjusted tinzaparin for venous thromboembolism prophylaxis in bariatric surgery patients weighing 160 kg or more.
Anvari, M; Crowther, MA; Douketis, JD; Eshaghpour, A; Ikesaka, RT; Li, A; Siegal, DM; Tiboni, M; Tseng, EK, 2021
)
0.62
" In hemodialysis patients, enoxaparin at once daily reduced dosing should be considered with trough and peak anti-Xa levels monitoring."( Management of Anticoagulation Therapy in Patients With Thromboembolism in the Context of Renal Dysfunction: Challenging Cases and Practical Algorithms.
Bahabri, A; Belostosky, V; Bhatt, MD; Chan, AKC, 2021
)
0.62
"Standard fixed-dose enoxaparin dosing regimens may not provide adequate prophylaxis against venous thromboembolism among obese hospitalized patients."( Comparison of two escalated enoxaparin dosing regimens for venous thromboembolism prophylaxis in obese hospitalized patients.
Davis, S; Gibson, CM; Hall, C; Schillig, JM, 2021
)
0.62
" The evidence suggests a need to evaluate different dosing protocols among burns patients in order to improve AFXa levels, with the aim of decreasing incidence of VTE in high-risk patients."( Venous thromboembolism in burns patients: Are we underestimating the risk and underdosing our prophylaxis?
Bortz, H; Cleland, H; Harms, KA; Lo, C; Lu, P; Paul, E, 2021
)
0.62
" Enoxaparin is traditionally dosed using weight."( Cancer-Associated Venous Thromboembolism Treatment With Anti-Xa Versus Weight-Based Enoxaparin: A Retrospective Evaluation of Safety and Efficacy.
Andrick, B; Graham, J; Grassi, S; Hart, K; Manikowski, J, 2021
)
0.62
"This study aims to evaluate efficacy (recurrent VTE) and safety (major bleed) between enoxaparin anti-Xa-guided dose adjustments and weight-based dosing in patients with cancer-associated VTE."( Cancer-Associated Venous Thromboembolism Treatment With Anti-Xa Versus Weight-Based Enoxaparin: A Retrospective Evaluation of Safety and Efficacy.
Andrick, B; Graham, J; Grassi, S; Hart, K; Manikowski, J, 2021
)
0.62
" There is no guideline regarding enoxaparin bridging in LVAD patients and a dosing strategy to ensure efficacy and safety is uncertain."( Enoxaparin Use and Adverse Events in Outpatients With a Continuous Flow Left Ventricular Assist Device at a Single Institution.
Alvarez, PA; Bernard, AM; Bream-Rouwenhorst, HR; Briasoulis, A; Czerniak, LC; Horner, KE, 2022
)
0.72
" Accordingly, recent data suggested a beneficial role of low molecular weight heparin (LMWH), but the optimal dosage of this treatment is unknown."( Clinical outcome with different doses of low-molecular-weight heparin in patients hospitalized for COVID-19.
Aimaretti, G; Avanzi, GC; Azzolina, D; Bellan, M; Cantaluppi, V; Capponi, A; Castello, LM; Cipollone, F; Colombo, C; Corte, FD; D'Ardes, D; Foglietta, M; Gallina, S; Grisafi, L; Hayden, E; Krengli, M; Lio, V; Malerba, M; Mennuni, MG; Patti, G; Petrilli, I; Pierdomenico, SD; Pirisi, M; Renda, G; Rognoni, A; Sainaghi, PP; Savoia, P; Spinoni, E; Zeppegno, P, 2021
)
0.62
" Our objective was to evaluate the efficacy of enoxaparin dosed 40 mg twice daily in achieving prophylactic plasma anti-Xa levels in obese burn patients."( Single-center Experience with Venous Thromboembolism Prophylaxis for Obese Burn Patients.
Jones, S; King, B; McKinzie, BP; Nizamani, R; Williams, FN, 2021
)
0.62
"This protocol enabled to improve the quality of prescriptions in terms of: dosage written in IU/kg/administration, frequency of administration, dilution conformity, and result of the first anti-Xa level."( [Enoxaparin and tinzaparin in pediatrics: Impact of recommendation on prescription quality and anti-Xa levels].
Bonnefoy, R; Bourdon, O; Farnoux, C; Hurtaud-Roux, MF; Kwon, T; Naudin, J; Noailly, J; Prot-Labarthe, S; Sadozaï, L, 2021
)
0.62
" Little consensus exists regarding who should receive extended enoxaparin thromboprophylaxis or how they should be dosed, namely whether to use weight-based or BMI-stratified dosing strategies."( Risk factors for postdischarge venous thromboembolism among bariatric surgery patients and the evolving approach to extended thromboprophylaxis with enoxaparin.
Dumon, KR; Garcia Whitlock, AE; O'Connor, K; Tewksbury, C; Williams, NN, 2021
)
0.62
" Weight-based dosing was often superior to standardized dosing in studies across disciplines in generating target anti-Xa levels however there is no consistent association of reduced risk of VTE with therapeutic anti-Xa levels."( Risk factors for postdischarge venous thromboembolism among bariatric surgery patients and the evolving approach to extended thromboprophylaxis with enoxaparin.
Dumon, KR; Garcia Whitlock, AE; O'Connor, K; Tewksbury, C; Williams, NN, 2021
)
0.62
" Transparency and consistency in data collection and reporting is needed to better assess and inform the ideal dosing strategy to prevent VTE following bariatric surgery."( Risk factors for postdischarge venous thromboembolism among bariatric surgery patients and the evolving approach to extended thromboprophylaxis with enoxaparin.
Dumon, KR; Garcia Whitlock, AE; O'Connor, K; Tewksbury, C; Williams, NN, 2021
)
0.62
"The use of initial weight-based enoxaparin dosing in trauma patients routinely achieved the prespecified target anti-Xa goal."( Achievement of goal anti-Xa activity with weight-based enoxaparin dosing for venous thromboembolism prophylaxis in trauma patients.
Huang, E; Martinez-Quinones, P; Robinson, T; Taylor, A; Waller, J; White, C, 2021
)
0.62
" This prospective, randomized, pilot study sought to explore the association between AT-III and anti-Xa goal attainment and to preliminarily evaluate two enoxaparin dosage adjustment strategies in patients with subprophylactic anti-Xa."( Impact of antithrombin III and enoxaparin dosage adjustment on prophylactic anti-Xa concentrations in trauma patients at high risk for venous thromboembolism: a randomized pilot trial.
Athota, K; Dowd, JR; Droege, CA; Droege, ME; Elterman, J; Ernst, NE; Gomaa, D; Hanseman, D; Mueller, EW; Philpott, CD; Robinson, BHR; Wakefield, D; Webb, ML, 2021
)
0.62
"The overall purpose of this study was to describe the impact of a tinzaparin weight-band dosing table for VTE prophylaxis on wound healing, thrombosis, and bleeding outcomes in patients undergoing total joint arthroplasty."( Impact of Weight-Band Dosing of Tinzaparin for Venous Thromboembolism Prophylaxis on Persistent Wound Drainage in Adult Patients Undergoing Hip and Knee Arthroplasty.
Antle, O; Cooper, C; Dersch-Mills, D; Kenny, A; Lowerison, J, 2022
)
0.72
" Our results do not suggest that the current weight-band dosing table for tinzaparin needs to be adjusted to optimize patient outcomes."( Impact of Weight-Band Dosing of Tinzaparin for Venous Thromboembolism Prophylaxis on Persistent Wound Drainage in Adult Patients Undergoing Hip and Knee Arthroplasty.
Antle, O; Cooper, C; Dersch-Mills, D; Kenny, A; Lowerison, J, 2022
)
0.72
" Current literature suggests weight-based dosing is superior to standard dosing for adequate chemoprophylaxis."( Effective use of weight-based enoxaparin for deep vein thrombosis chemoprophylaxis in patients with traumatic brain injury.
Huang, E; Martinez-Quinones, P; Robinson, T; Taylor, A; White, CQ, 2022
)
0.72
"Use of weight-based enoxaparin dosing in the setting of TBI shows promise without an increased incidence of ICH expansion when compared to other studies."( Effective use of weight-based enoxaparin for deep vein thrombosis chemoprophylaxis in patients with traumatic brain injury.
Huang, E; Martinez-Quinones, P; Robinson, T; Taylor, A; White, CQ, 2022
)
0.72
" After observing higher than expected VTE rates within our center's Trauma Quality Improvement Program data, we instituted a change in our VTE prophylaxis protocol, moving to enoxaparin dosing titrated by anti-Xa levels."( Enoxaparin titrated by anti-Xa levels reduces venous thromboembolism in trauma patients.
Collier, BR; Faulks, ER; Gates, RS; Gillen, JR; Lollar, DI; Smith, J, 2022
)
0.72
" Optimal thromboprophylaxis dosing in high-risk patients is unknown."( Efficacy and Safety of Therapeutic-Dose Heparin vs Standard Prophylactic or Intermediate-Dose Heparins for Thromboprophylaxis in High-risk Hospitalized Patients With COVID-19: The HEP-COVID Randomized Clinical Trial.
Agrawal, N; Anderson, VE; Bonaca, M; Cohen, M; Cohoon, KP; Diab, W; Giannis, D; Gianos, E; Goldin, M; Halperin, JL; Hsia, J; Khanijo, S; Lesser, ML; Lewis, PA; Lund, JM; Mignatti, A; Ochani, K; Rahman, H; Sharifova, G; Sison, CP; Spyropoulos, AC; Tafur, A; Wang, J; Weitz, JI, 2021
)
0.62
"Our study objective was to identify a subcutaneous enoxaparin dosage that provided a consistent anticoagulant intensity in dogs."( Anticoagulant profile of subcutaneous enoxaparin in healthy dogs.
Andrews, C; Archer, T; Brooks, MB; Frum, J; Havill, K; Langston, C; Mackin, A; Thomason, J, 2022
)
0.72
"Anti-Xa-guided enoxaparin dosing for VTE prophylaxis in neurosurgical patients may help prevent major bleeding."( Supraprophylactic Anti-Factor Xa Levels Are Associated with Major Bleeding in Neurosurgery Patients Receiving Prophylactic Enoxaparin.
Cua, S; May, CC; Powers, CJ; Smetana, KS, 2022
)
0.72
" The dose-response relationship with twice-daily milvexian was significant (one-sided P<0."( Milvexian for the Prevention of Venous Thromboembolism.
Ageno, W; Gailani, D; Hylek, EM; Lassen, MR; Mahaffey, KW; Notani, RS; Raskob, GE; Roberts, R; Segers, A; Strony, J; Weitz, JI, 2021
)
0.62
"The evaluation criteria for dosage of low-molecular-weight heparin (LMWH) for pregnant women at high risk of venous thromboembolism (VTE) remain unclear."( Comparison of doses of heparin for venous thromboembolism and bleeding in pregnant women.
Guo, L; Luo, Y; Mu, L; Xiao, S; Ye, Z; Zhang, J, 2022
)
0.72
"No DVT developed in COVID-19 patients hospitalized in general wards, independently of enoxaparin dosing used for thromboprophylaxis."( Enoxaparin for thromboprophylaxis in hospitalized COVID-19 patients: The X-COVID-19 Randomized Trial.
Agostinis, M; Antolini, L; Barberis, D; Birocchi, S; Bonacchini, L; Carioti, G; Cattaneo, M; Gazzaniga, G; Grazia Valsecchi, M; Massaini, G; Merli, M; Morici, N; Podda, G; Saverio Serino, F; Trezzi, M, 2022
)
0.72
" We investigated whether our dosage regimen of enoxaparin resulted in similar serum aFXa levels in female and male patients undergoing bariatric surgery."( Comparison of Anti-factor Xa Levels in Female and Male Patients with Obesity After Enoxaparin Application for Thromboprophylaxis.
Duprée, A; Izbicki, J; Lautenbach, A; Mann, O; von Kroge, P; Wagner, J; Wolter, S; Wruck, H, 2022
)
0.72
"Individual enoxaparin dosage regimens for men and women do not seem to be required."( Comparison of Anti-factor Xa Levels in Female and Male Patients with Obesity After Enoxaparin Application for Thromboprophylaxis.
Duprée, A; Izbicki, J; Lautenbach, A; Mann, O; von Kroge, P; Wagner, J; Wolter, S; Wruck, H, 2022
)
0.72
"The aim of this study was to evaluate the effectiveness of a body mass index (BMI)-based enoxaparin prophylaxis dosing protocol at achieving target anti-factor Xa (anti-Xa) concentrations in the trauma population."( Evaluation of anti-factor Xa concentrations using a body mass index-based enoxaparin dosing protocol for venous thromboembolism prophylaxis in trauma patients.
Carver, TW; Herrmann, DJ; Hubbard, S; O'Keefe, MM; Peppard, WJ; Prom, A; Rein, LE, 2022
)
0.72
" Dosing per EBV and TBW was the only variables associated with reaching target anti-Xa concentrations within the study."( Evaluation of anti-factor Xa concentrations using a body mass index-based enoxaparin dosing protocol for venous thromboembolism prophylaxis in trauma patients.
Carver, TW; Herrmann, DJ; Hubbard, S; O'Keefe, MM; Peppard, WJ; Prom, A; Rein, LE, 2022
)
0.72
" Analysis 3 compared standard dosing to dose adjustment with the primary outcome being anti-Xa adequacy; secondary outcomes were VTE, pulmonary embolism, and bleeding complications."( Relationship between anti-Xa level achieved with prophylactic low-molecular weight heparin and venous thromboembolism in trauma patients: A systematic review and meta-analysis.
Anantha, RV; Connell, M; Kung, JY; Parker, A; Raffael, K; Strickland, M; Verhoeff, K, 2022
)
0.72
"This study aimed to compare initiating warfarin at the recommended dosing regimen versus empirically lowered doses intended to account for the variation in warfarin sensitivity."( Comparison of Warfarin Initiation at 3 mg Versus 5 mg for Anticoagulation of Patients with Mechanical Mitral Valve Replacement Surgery: A Prospective Randomized Trial.
Ahmed, MA; El Wakeel, LM; Sabry, S; Saleh, A, 2022
)
0.72
" Enoxaparin, a commonly prescribed low-molecular-weight heparin, is dosed based on body weight irrespective of obesity status to achieve maximum concentration within a narrow therapeutic or prophylactic target range."( Use of Real-World Data and Physiologically-Based Pharmacokinetic Modeling to Characterize Enoxaparin Disposition in Children With Obesity.
Carreño, FO; Edginton, AN; Gerhart, JG; Gonzalez, D; Hornik, CP; Kirkpatrick, CM; Kumar, KR; Lee, CR; Loop, MS; Sinha, J, 2022
)
0.72
" Weight-based enoxaparin dosing was administered using a pharmacy-driven protocol, which later included a low molecular weight, anti-Xa level directed-dose adjustment strategy."( Outcomes of Prophylactic Enoxaparin Against Venous Thromboembolism in Hospitalized Children.
Bennett, E; Delgado-Corcoran, C; Faustino, EV; Heyrend, C; Pannucci, CJ; Wilcox, R, 2022
)
0.72
"Trauma patients are at high risk of developing venous thromboembolism (VTE), and standard dosing enoxaparin regimens may be inadequate for prophylaxis."( The efficacy of weight-based enoxaparin dosing for venous thromboembolism prophylaxis in trauma patients: A systematic review and meta-analysis.
Cole, E; Ebeid, A; Stallwood-Hall, C, 2022
)
0.72
"A systematic database search was undertaken for studies comparing standard versus weight-based dosing of enoxaparin for VTE prophylaxis in adult trauma patients, 18 years or older."( The efficacy of weight-based enoxaparin dosing for venous thromboembolism prophylaxis in trauma patients: A systematic review and meta-analysis.
Cole, E; Ebeid, A; Stallwood-Hall, C, 2022
)
0.72
"Compared with standard dosing, weight-based enoxaparin dosing regimens are associated with increased odds of prophylactic range AFXa levels."( The efficacy of weight-based enoxaparin dosing for venous thromboembolism prophylaxis in trauma patients: A systematic review and meta-analysis.
Cole, E; Ebeid, A; Stallwood-Hall, C, 2022
)
0.72
" Patients received standard fixed enoxaparin dosing at 30 mg twice daily in head and neck (H&N) and 40 mg daily in breast reconstructions."( Standard Fixed Enoxaparin Dosing for Venous Thromboembolism Prophylaxis Leads to Low Peak Anti-Factor Xa Levels in Both Head and Neck and Breast Free Flap Patients.
Acarturk, TO; Ambani, SW; Bengur, FB; Cruz, C; Gimbel, ML; Kubik, MW; Manders, EK; Nguyen, VT; Solari, MG; Sridharan, S; Varelas, LJ, 2022
)
0.72
" Standard fixed enoxaparin dosing for postoperative VTE prophylaxis does not achieve target afXa levels for the majority of our free flap patients."( Standard Fixed Enoxaparin Dosing for Venous Thromboembolism Prophylaxis Leads to Low Peak Anti-Factor Xa Levels in Both Head and Neck and Breast Free Flap Patients.
Acarturk, TO; Ambani, SW; Bengur, FB; Cruz, C; Gimbel, ML; Kubik, MW; Manders, EK; Nguyen, VT; Solari, MG; Sridharan, S; Varelas, LJ, 2022
)
0.72
"The optimal enoxaparin dosing strategy to achieve venous thromboembolism (VTE) prophylaxis in trauma patients remains unclear."( One size does not fit all: Sex bias in pharmacologic venous thromboembolism prophylaxis.
Berndtson, AE; Borst, JM; Box, K; Costantini, TW; Doucet, JJ; Godat, LN; Kirchberg, TN; Modi, RN; Smith, AM, 2023
)
0.91
" To improve the accuracy of VTE chemoprophylaxis, sex should be considered as a variable in enoxaparin dosing models."( One size does not fit all: Sex bias in pharmacologic venous thromboembolism prophylaxis.
Berndtson, AE; Borst, JM; Box, K; Costantini, TW; Doucet, JJ; Godat, LN; Kirchberg, TN; Modi, RN; Smith, AM, 2023
)
0.91
"Current enoxaparin dosing guidelines in children are based on total body weight."( Optimal dosing of enoxaparin in overweight and obese children.
Al-Sallami, H; Derbalah, A; Duffull, S; Job, K; Sherwin, CM, 2022
)
0.72
" The fitted model was used to evaluate the current standard dosing and identify an optimal dosing regimen for obese children."( Optimal dosing of enoxaparin in overweight and obese children.
Al-Sallami, H; Derbalah, A; Duffull, S; Job, K; Sherwin, CM, 2022
)
0.72
" Simulations from the model showed that fat-free mass-based dosing could achieve the target anti-Xa activity at steady state in 77."( Optimal dosing of enoxaparin in overweight and obese children.
Al-Sallami, H; Derbalah, A; Duffull, S; Job, K; Sherwin, CM, 2022
)
0.72
" Based on this model, a unified dosing regimen was proposed that will potentially improve the success rate of target attainment in overweight/obese patients without the need for patient body size categorisation."( Optimal dosing of enoxaparin in overweight and obese children.
Al-Sallami, H; Derbalah, A; Duffull, S; Job, K; Sherwin, CM, 2022
)
0.72
" Standard trauma prophylaxis dosing with enoxaparin 30 mg twice daily may be inadequate to prevent VTEs."( Impact of Increased Enoxaparin Dosing on Anti-Xa Levels for Venous Thromboembolism Prophylaxis in Trauma Patients.
Bellfi, LT; Boudreau, R; Greiffenstein, P; Hunt, JP; Marr, A; Mosier, W; Rueb, N; Schoen, J; Smith, A; Stuke, L; Zimmerman, SA, 2022
)
0.72
"A retrospective study was performed from January 2020 to June 2021 at a Level I trauma center, following implementation of an increased enoxaparin dosing strategy."( Impact of Increased Enoxaparin Dosing on Anti-Xa Levels for Venous Thromboembolism Prophylaxis in Trauma Patients.
Bellfi, LT; Boudreau, R; Greiffenstein, P; Hunt, JP; Marr, A; Mosier, W; Rueb, N; Schoen, J; Smith, A; Stuke, L; Zimmerman, SA, 2022
)
0.72
"This study demonstrated that an increased dosing strategy decreased rates of subtherapeutic anti-Xa levels and trended toward lower overall VTE rates in trauma."( Impact of Increased Enoxaparin Dosing on Anti-Xa Levels for Venous Thromboembolism Prophylaxis in Trauma Patients.
Bellfi, LT; Boudreau, R; Greiffenstein, P; Hunt, JP; Marr, A; Mosier, W; Rueb, N; Schoen, J; Smith, A; Stuke, L; Zimmerman, SA, 2022
)
0.72
"We aimed to evaluate the effectiveness and safety of enoxaparin compared with UFH when used at their standard/intermediate dosing in COVID-19 patients."( Effectiveness and Safety of Enoxaparin Versus Unfractionated Heparin as Thromboprophylaxis in Hospitalized COVID-19 Patients: Real-World Evidence.
Abraham, I; Al Saeed, J; Al-Bassam, S; Al-Makki, S; Alamer, A; AlLehaibi, LH; Almulhim, A; Alomar, M; Alrwaili, NR; Alsheef, M; Alsultan, S, 2023
)
0.91
" Patient’s compliance and quality of life were better with E due to shortened hospitalization, decreased need for testing of coagulation (every 6 h for UH), better dosing (SC every 12 h for E versus continuous infusion for UH), shortened immobilization during the immediate postoperative period with subsequent improvement in the psychological status, as well as due to lack of significant side effects."( Enoxaparin versus Unfractionated Heparin for the Perioperative Anticoagulant Therapy in Patients with Mechanical Prosthetic Heart Valve Undergoing Non-Cardiac Surgery.
Andronesi, A; Camburu, G; Iliuta, L; Rac-Albu, M, 2022
)
0.72
" We aimed to characterize the variability in the association between dose and anti-Xa levels, identify patient and dialysis characteristics that explained this variability, and optimize nadroparin dosing based on the identified characteristics."( Optimising the Nadroparin Dose for Thromboprophylaxis During Hemodialysis by Developing a Population Pharmacodynamic Model Using Anti-Xa Levels.
Diepstraten, J; Franssen, CFM; Jaspers, TCC; Khorsand, N; Koomen, JV; Lukens, MV; Maat, B; Meijer, CE; Touw, DJ; van den Bemt, PMLA; Vleming, LJ, 2022
)
0.72
"To evaluate fixed compared with weight-based enoxaparin dosing to achieve prophylactic anti-Xa levels after cesarean delivery."( Weight-Based Compared With Fixed-Dose Enoxaparin Prophylaxis After Cesarean Delivery: A Randomized Controlled Trial.
Allshouse, AA; Branch, DW; Bruno, AM; Campbell, HM; Lim, MY; Metz, TD; Silver, RM, 2022
)
0.72
"Weight-based dosing was more effective than fixed enoxaparin dosing in achieving prophylactic peak anti-Xa levels after cesarean delivery."( Weight-Based Compared With Fixed-Dose Enoxaparin Prophylaxis After Cesarean Delivery: A Randomized Controlled Trial.
Allshouse, AA; Branch, DW; Bruno, AM; Campbell, HM; Lim, MY; Metz, TD; Silver, RM, 2022
)
0.72
"Obesity is a well-recognised risk factor for venous thromboembolism, and increased dosing of pharmacological prophylaxis is recommended in obese inpatients."( Improving compliance with venous thromboembolism prophylaxis guidelines in obese inpatients.
Bortz, H; Chee, A; McFadyen, JD; Yip, J, 2022
)
0.72
"To review the evidence cited in recent consensus documents providing recommendations for drug dosing for venous thromboembolism (VTE) prophylaxis in obese trauma patients."( Pharmacologic venous thromboembolism prophylaxis in obese trauma patients.
Barletta, JF; Erstad, BL, 2023
)
0.91
" These documents address key aspects of pharmacologic prophylaxis, one of which is drug dosing in obesity."( Pharmacologic venous thromboembolism prophylaxis in obese trauma patients.
Barletta, JF; Erstad, BL, 2023
)
0.91
"The strength of the evidence surrounding dosing recommendations for VTE prophylaxis in obese trauma patients is low."( Pharmacologic venous thromboembolism prophylaxis in obese trauma patients.
Barletta, JF; Erstad, BL, 2023
)
0.91
" All patients were initially treated with TDE for 2 weeks before transitioning to ODE maintenance therapy (n=39; 55%) or continuing with TDE dosing (n=32; 45%)."( Once-daily Compared With Twice-daily Enoxaparin Maintenance Therapy Appears Safe and Efficacious in Pediatric Venous Thromboembolism.
Addy, K; Brown, D; Gibson, A; Hashmi, SS; Menon, N; Montanez, N; Rodriguez, N; Srivaths, L, 2023
)
0.91
" Moreover, optimal dosing regimens achieving anti-Xa target levels (0."( Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID-19 intensive care unit patients.
Endeman, H; Hunfeld, NGM; Kruip, MJHA; Preijers, T; Romano, LGR, 2023
)
0.91
" Using Monte Carlo simulations (n = 1000), predefined dosing regimens were evaluated."( Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID-19 intensive care unit patients.
Endeman, H; Hunfeld, NGM; Kruip, MJHA; Preijers, T; Romano, LGR, 2023
)
0.91
" Monte Carlo simulations demonstrated that 5700 IU BID was the most optimal dosing regimen of the simulated regimens for achieving prespecified steady-state t = 4 h anti-Xa levels with 56."( Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID-19 intensive care unit patients.
Endeman, H; Hunfeld, NGM; Kruip, MJHA; Preijers, T; Romano, LGR, 2023
)
0.91
" Furthermore, of the simulated regimens, targeted anti-Xa levels were most adequately achieved with a dosing regimen of 5700 IU BID."( Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID-19 intensive care unit patients.
Endeman, H; Hunfeld, NGM; Kruip, MJHA; Preijers, T; Romano, LGR, 2023
)
0.91
" Utilization of closed incision negative pressure wound therapy for the treatment of postoperative wound drainage did not differ between dosing groups."( Administration of Prophylactic Enoxaparin on the Morning of Surgery Does Not Increase Risk of Blood Transfusion or Wound Drainage Following Internal Fixation of Geriatric Femur Fractures.
Boakye, LAT; Cluts, LM; Moloney, GB; Palmeri, C, 2023
)
0.91
" capped (< 1 mg/kg) enoxaparin dosing regimen."( Management of venous thromboembolism in morbidly obese patients: a 10-year review.
Donarelli, C; Ho, P; Khattak, Z; Kwok, A; Lai, J; Lim, HY; Lui, B; Wee, B, 2023
)
0.91
" It can be debated whether nadroparin is currently dosed optimally in intensive care unit patients and our findings encourage the investigation of higher and tailored dosing of nadroparin in the critically ill."( Low and Highly Variable Exposure to Prophylactic LMWH Nadroparin in Critically Ill Patients: Back to the Drawing Board for Prophylactic Dosing?
Diepstraten, J; Kruip, MJHA; Ter Heine, R; van der Heiden, PLJ; van Rongen, A; Zijlstra, MP, 2023
)
0.91
" The optimal dosing and efficacy of protamine for this indication needs further investigation."( Massive intentional enoxaparin overdose managed with minimal protamine: A single case report.
de Olano, J; Howland, MA; Su, MK, 2023
)
0.91
" There is concern whether body mass index (BMI)-based enoxaparin dosing consistently achieves prophylactic targets in patients with severe obesity."( Effectiveness of Body Mass Index-Based Prophylactic Enoxaparin Dosing in Bariatric Surgery Patients.
Chang, CK; Herrmann, DJ; Higgins, RM; Kindel, T; Peppard, WJ; Rein, L, 2023
)
0.91
" An EBV-based dosing regimen may better account for patient height and is supported by a greater correlation with anti-Xa levels with dosing based on EBV than BMI."( Effectiveness of Body Mass Index-Based Prophylactic Enoxaparin Dosing in Bariatric Surgery Patients.
Chang, CK; Herrmann, DJ; Higgins, RM; Kindel, T; Peppard, WJ; Rein, L, 2023
)
0.91
"Guidelines for enoxaparin dosing after trauma recommend an initial dose of 40 mg twice daily for most patients and then adjusting by anti-Xa levels."( Creatinine Clearance May Predict Goal Enoxaparin Dose in Trauma.
Dhillon, NK; Drevets, P; Fierro, NM; Ley, EJ; Park, G; Stupinski, J, 2023
)
0.91
" CrCl dosing guidance may reduce the time to goal anti-Xa levels and the frequency of anti-Xa measurements."( Creatinine Clearance May Predict Goal Enoxaparin Dose in Trauma.
Dhillon, NK; Drevets, P; Fierro, NM; Ley, EJ; Park, G; Stupinski, J, 2023
)
0.91
" VTE prophylaxis with weight-based enoxaparin dosing may be more effective than the standard dosing regimen for overweight and obese patients; however, weight-based dosing is not practiced routinely."( Evaluating Adequacy of VTE Prophylaxis Dosing with Enoxaparin for Overweight and Obese Patients on an Orthopedic-Medical Trauma Comanagement Service.
Dailey, H; Jovin, F; Perrin, A; Sheth, H; Smith, R; Snyder, V, 2023
)
0.91
" Emerging literature supports anti-factor Xa (AFXa) monitoring for patients on enoxaparin (LMWH), although a significant knowledge gap remains regarding the optimal dosing and monitoring in EGS patients."( Anti-Factor Xa Monitoring of Enoxaparin Thromboembolism Prophylaxis in Emergency General Surgery Patients.
Al Tannir, AH; Biesboer, EA; de Moya, M; Figueroa, J; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
" Adjustment to dosing and repeat AFXa measurement after the adjusted third dose was obtained."( Anti-Factor Xa Monitoring of Enoxaparin Thromboembolism Prophylaxis in Emergency General Surgery Patients.
Al Tannir, AH; Biesboer, EA; de Moya, M; Figueroa, J; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
" Of patients who had an initial low AFXa, remained admitted, and underwent dosing adjustment and AFXa reassessment (27%), the majority were adjusted to either 30 or 40 mg of LMWH twice daily (23."( Anti-Factor Xa Monitoring of Enoxaparin Thromboembolism Prophylaxis in Emergency General Surgery Patients.
Al Tannir, AH; Biesboer, EA; de Moya, M; Figueroa, J; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
"Standard LMWH dosing provides inadequate AFXa inhibition for adequate VTE prophylaxis."( Anti-Factor Xa Monitoring of Enoxaparin Thromboembolism Prophylaxis in Emergency General Surgery Patients.
Al Tannir, AH; Biesboer, EA; de Moya, M; Figueroa, J; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
"Different nadroparin dosing is required for patients undergoing mechanical ventilation and extracorporeal membrane oxygenation to achieve the same targets as those for non-critically ill patients."( Population Pharmacokinetics and Probability of Target Attainment Analysis of Nadroparin in Different Stages of COVID-19.
Borys, M; Cios, W; Czuczwar, M; Okuńska, P; Piwowarczyk, P; Raszewski, G; Szczukocka, M; Wiczling, P, 2023
)
0.91
"This study aimed to compare the efficacy in reaching prophylactic anti-Xa levels and adverse effects profile of the 2 weight-based enoxaparin dosing protocols."( Comparison of postpartum anti-Xa levels following enoxaparin administration to prevent venous thromboembolism using 2 weight-based protocols: a randomized controlled trial.
Eitam, H; Haj, R; Kassabri, R; Massalha, M; Nachum, Z; Yefet, E, 2023
)
0.91
" A fixed Enoxaparin dosing regimen is the standard of care for chemoprophylaxis in most institutions; however, breakthrough venous thromboembolism events are still reported."( The efficacy of various Enoxaparin dosing regimens in general surgery patients: A systematic review.
Al Tannir, AH; Biesboer, EA; de Moya, MA; Figueroa, J; Harding, E; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
" Articles were included if Enoxaparin dosing regimens were evaluated by anti-Xa levels."( The efficacy of various Enoxaparin dosing regimens in general surgery patients: A systematic review.
Al Tannir, AH; Biesboer, EA; de Moya, MA; Figueroa, J; Harding, E; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
"Fixed Enoxaparin dosing regimens are not correlated with adequate anti-Xa levels in general surgery patients."( The efficacy of various Enoxaparin dosing regimens in general surgery patients: A systematic review.
Al Tannir, AH; Biesboer, EA; de Moya, MA; Figueroa, J; Harding, E; Morris, RS; Murphy, PB; Pokrzywa, CJ, 2023
)
0.91
"Dosing prophylactic enoxaparin using a BV-based dosing guideline significantly increased attainment of target anti-Xa levels."( Evaluation of a novel blood volume-based enoxaparin dosing guideline for venous thromboembolism prophylaxis in trauma patients.
Carver, TW; Herrmann, DJ; Holschbach, L; Hubbard, S; Langenstroer, EA; O'Keefe, MM; Peppard, WJ; Rein, L, 2023
)
0.91
" Adequate dosing was defined as enoxaparin 30 mg or 40 mg twice daily."( Inadequate Venous Thromboembolism Chemoprophylaxis Is Associated With Higher Venous Thromboembolism Rates Among Trauma Patients With Epidurals.
Alexander, J; Dhillon, NK; Fierro, NM; Ikonte, C; Ley, EJ; Mason, R; Muniz, T; Siletz, AE, 2023
)
0.91
" To evaluate the safety of this dosing regimen, data was then compared to patients from our institution with similar TBI profiles who had received 5,000 units (U) of subcutaneous heparin (SQH) prophylaxis."( Early administration of high dose enoxaparin after traumatic brain injury.
Cho, YW; Cripps, M; DeAtkine, E; Fesmire, A; Park, C; Scrushy, M; Wan, B; Zhu, M, 2023
)
0.91
"Prior studies have demonstrated that enoxaparin 40 mg BID dosing is superior to traditional VTE prophylaxis in trauma patients."( Early administration of high dose enoxaparin after traumatic brain injury.
Cho, YW; Cripps, M; DeAtkine, E; Fesmire, A; Park, C; Scrushy, M; Wan, B; Zhu, M, 2023
)
0.91
" A review of the literature revealed that the optimal strategy to treat an LMWH overdose is unknown, with treatment of overdoses ranging from clinical observation to aggressive protamine dosing in reported cases."( Management of an unintentional enoxaparin overdose: A case report and literature review.
Gellatly, RM; Zhou, FN, 2023
)
0.91
" Weight-based dosing is suitable for obese patients."( The effect of renal impairment and obesity on anti-Xa peak and trough levels in patients receiving therapeutic doses of nadroparin: a comparison with control patients.
Hackeng, CM; Knibbe, CAJ; Mast, L; Peeters, MYM; Söhne, M; van den Broek, MPH, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Pathways (2)

PathwayProteinsCompounds
Enoxaparin Action Pathway213
Ardeparin Action Pathway213

Bioassays (1)

Assay IDTitleYearJournalArticle
AID1346098Human serpin family C member 1 (Blood coagulation components)1995Thrombosis and haemostasis, Mar, Volume: 73, Issue:3
A comparative study of three low-molecular weight heparins (LMWH) and unfractionated heparin (UH) in healthy volunteers.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5,314)

TimeframeStudies, This Drug (%)All Drugs %
pre-19905 (0.09)18.7374
1990's592 (11.14)18.2507
2000's2205 (41.49)29.6817
2010's1874 (35.27)24.3611
2020's638 (12.01)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 72.19

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index72.19 (24.57)
Research Supply Index8.87 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index127.05 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (72.19)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,423 (25.12%)5.53%
Reviews517 (9.13%)6.00%
Case Studies997 (17.60%)4.05%
Observational95 (1.68%)0.25%
Other2,633 (46.48%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (226)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women. [NCT00967382]Phase 3292 participants (Actual)Interventional2000-07-31Completed
Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial. [NCT01124058]Phase 139 participants (Actual)Interventional2010-07-31Completed
The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study [NCT05284552]Phase 240 participants (Anticipated)Interventional2022-07-12Recruiting
Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial) [NCT01321788]300 participants (Anticipated)Observational2011-01-31Recruiting
Systemic Anticoagulation With Full Dose Low Molecular Weight Heparin (LMWH) Vs. Prophylactic or Intermediate Dose LMWH in High Risk COVID-19 Patients (HEP-COVID Trial) [NCT04401293]Phase 3257 participants (Actual)Interventional2020-04-26Completed
Effect of Low-Molecular-Weight-Heparin (LMWH) on Pregnancy Outcome in Women With Multiple Failures of IVF-ET [NCT03701750]Phase 4240 participants (Anticipated)Interventional2018-11-01Recruiting
Prospective Observational Study of the Direct Oral Anticoagulants Periprocedural Management [NCT03182218]1,100 participants (Actual)Observational2015-02-28Completed
Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation [NCT01356615]27 participants (Actual)Interventional2011-03-31Completed
A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtus [NCT03671174]420 participants (Anticipated)Interventional2019-08-02Recruiting
A Multi-centre Randomised Adaptive Platform Clinical Trial to Assess Clinical, Virological and Immunological Outcomes in Patients With SARS-CoV-2 Infection (COVID-19) [NCT04483960]Phase 32,400 participants (Anticipated)Interventional2020-07-28Recruiting
Low Molecular Weight hEparin vs. Aspirin Post-partum [NCT05058924]50 participants (Anticipated)Interventional2021-08-29Recruiting
A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembol [NCT02981472]Phase 2192 participants (Actual)Interventional2017-01-19Completed
[NCT01315093]Phase 2/Phase 350 participants (Actual)Interventional2010-11-30Completed
Low-Dose Tenecteplase in Covid-19 Patients With Acute Pulmonary Embolism: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT04558125]Phase 42 participants (Actual)Interventional2020-09-08Terminated(stopped due to Identification of eligible patients was slower than anticipated.)
Effects of Injection Tinzaparin Prophylactic Dose (4,500 IU Anti-Xa) on Thrombin Generation in Patients With Multiple Myeloma, Lymphoma Patients and Patients Hospitalized for an Acute Medical Condition. [NCT02260414]Phase 219 participants (Actual)Interventional2015-04-14Completed
Safety and Efficacy of Switching From Direct Oral Anticoagulants to Low Molecular Weight Heparin in Cancer Patients With Atrial Fibrillation During Antineoplastic Therapy [NCT04508855]240 participants (Anticipated)Observational2020-08-01Recruiting
A Randomized, Open-Label Trial of Therapeutic Anticoagulation in COVID-19 Patients With an Elevated D-Dimer [NCT04377997]Phase 2300 participants (Anticipated)Interventional2020-05-15Recruiting
Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy [NCT02238444]Phase 460 participants (Anticipated)Interventional2014-09-01Recruiting
Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism [NCT01164046]Phase 356 participants (Actual)Interventional2010-08-31Terminated(stopped due to Due to slow inclusion of patients)
Treatment Approach in Patients Diagnosed With Pulmonary Thromboembolism With Intermediate-High Risk Interms of Early Mortality After the Establisment of Ege Pulmonary Embolism Team [NCT05512702]100 participants (Anticipated)Observational2022-06-03Recruiting
Efficacy, Safety and Pharmacokinetics of Tinzaparin During Slow Low Efficient Daily Dialysis in Intensive Care Patients [NCT03614741]Phase 460 participants (Anticipated)Interventional2018-12-03Recruiting
Evaluation of Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China [NCT03311984]200 participants (Anticipated)Observational2017-08-15Active, not recruiting
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment [NCT03230162]Phase 3100 participants (Anticipated)Interventional2017-06-01Recruiting
Intensive Dose Tinzaparin in Hospitalized COVID19 Patients [NCT05036824]300 participants (Anticipated)Observational2021-10-01Recruiting
Hamburg Edoxaban for Anticoagulation in COVID-19 Study [NCT04542408]Phase 3140 participants (Actual)Interventional2020-11-12Completed
Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome:a Prospective, Multicenter, Non-randomized Controlled Intervention Study [NCT05604859]Phase 4350 participants (Anticipated)Interventional2022-08-19Recruiting
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study [NCT03045406]Phase 31,168 participants (Actual)Interventional2017-04-13Active, not recruiting
Postpartum Prophylaxis for PE Randomized Control Trial Pilot: A Pilot Study Assessing Feasibility of a Randomized, Open-label Trial of Low-Molecular-Weight-Heparin for Postpartum Prophylaxis in Women at Risk of Developing Venous Thromboembolism [NCT01274637]Phase 362 participants (Actual)Interventional2011-03-31Completed
Prophylaxis of Venous Thromboembolic Disease With Low Molecular Weight (LMWH) (TINzaparin) in Patients With Metastatic Colorectal Cancer Who Start the First Line of Treatment. [NCT05625932]Phase 3526 participants (Anticipated)Interventional2023-03-02Recruiting
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE [NCT05171075]Phase 31,020 participants (Anticipated)Interventional2022-09-27Recruiting
A Different Approach to Preventing Thrombosis (ADAPT): A Randomized Controlled Trial Comparing Low Molecular Weight Heparin to Acetylsalicylic Acid in Orthopedic Trauma Patients [NCT02774265]Phase 3329 participants (Actual)Interventional2016-01-31Completed
A Prospective Cohort Study to Examine the Need to Adjust the Dose of Anticoagulant Apixaban When Used in Patients With Atrial Fibrillation and Obesity [NCT03893591]82 participants (Actual)Observational2019-05-06Completed
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial) [NCT02744092]811 participants (Actual)Interventional2016-12-13Completed
Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy [NCT02875717]500 participants (Actual)Observational2009-01-31Completed
Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System. [NCT00628576]Phase 399 participants (Actual)Interventional1993-10-31Completed
Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial [NCT00750451]0 participants Interventional2006-01-31Completed
FRAG-A001-401: Dalteparin Sodium Injection (Fragmin), Multicenter, Open-Label, Single-arm, Long Term (52 Weeks) Study for Understanding the Safety and Efficacy in Subjects With Malignancies and Symptomatic Venous Thromboembolism [NCT00942968]Phase 4338 participants (Actual)Interventional2009-06-30Completed
A Pilot Study To Investigate the Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving Direct-acting Anticoagulants (DOACS) (ENZA-D) [NCT03920566]15 participants (Anticipated)Observational2019-05-31Not yet recruiting
Effect of Anticoagulation in Reducing the Incidence of Splenic/Portal Vein Thrombosis Post-Laparoscopic Splenectomy Protocol Number: 5698 [NCT00769873]Phase 235 participants (Actual)Interventional2006-10-31Terminated(stopped due to Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.)
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice [NCT00922766]618 participants (Actual)Observational2009-05-31Completed
Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL) [NCT00800137]Phase 4984 participants (Actual)Interventional2008-12-31Terminated(stopped due to At time of pre-specified 2nd interim analysis)
Prospective Cohort Study of Bone Mineral Density and Calcium-phosphorus Metabolism in RSA Patients: Low Molecular Weight Heparin Use Versus Control [NCT05878574]344 participants (Anticipated)Observational2022-11-01Recruiting
Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients [NCT04248348]600 participants (Anticipated)Observational2018-12-01Recruiting
Effectiveness of Weight-adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID-2019. The Multicenter Randomized Controlled Open-label Trial COVI-DOSE [NCT04373707]Phase 41,000 participants (Actual)Interventional2020-05-13Completed
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection [NCT04508439]130 participants (Anticipated)Interventional2020-06-20Recruiting
An Open-Label Randomized Control Trial of Pre-Operative Low Molecular Weight Heparin Versus Tapered Warfarin as Bridging Therapy for Patients With Implantation of Pacemaker or Defibrillator [NCT02094157]Phase 3173 participants (Actual)Interventional2007-12-31Terminated(stopped due to Change of practice made further recruitment impossible)
Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study [NCT03200613]Phase 28 participants (Actual)Interventional2017-09-01Terminated(stopped due to study not feasible due to too slow recruitment)
A Prospective Randomised Controlled Trial [NCT02086019]250 participants (Actual)Interventional2014-05-01Completed
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection [NCT04787510]50 participants (Actual)Observational [Patient Registry]2020-12-23Completed
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial [NCT05735639]Phase 46,660 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer [NCT05498428]Phase 2390 participants (Anticipated)Interventional2022-11-11Recruiting
A Pilot Study of Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis of the Upper Extremity [NCT00216866]Phase 270 participants Interventional2002-09-30Completed
The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study [NCT04918524]126 participants (Anticipated)Observational2018-09-11Recruiting
The Use of Extended Perioperative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer: A Pilot Randomized Controlled Trial [NCT00967148]18 participants (Actual)Interventional2009-06-30Completed
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY. [NCT01589146]Phase 3400 participants (Anticipated)Interventional2010-09-30Recruiting
A 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients [NCT00662831]Phase 2/Phase 3276 participants (Actual)Interventional2008-04-30Completed
Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial [NCT01029821]100 participants (Anticipated)Interventional2010-02-28Recruiting
Thromboprophylaxis in Critically Ill Patients: a Prospective, Randomized Study Comparing Anti-Xa Activities Following Subcutaneous Administration of 5000 IU and 7500 IU Dalteparin [NCT00437697]Phase 490 participants Interventional2003-04-30Terminated
Combined Sonographic Examination and Placenta Protein 13 (PP13) to Compare the Risk for Development of Preeclampsia Among Among Pregnant Women With and Without a History of Preterm Delivery and Those Treated by Progesterone or Clexane [NCT00928213]Phase 2/Phase 31,000 participants (Anticipated)Interventional2009-08-31Not yet recruiting
Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses [NCT02719418]28 participants (Actual)Observational2016-02-01Completed
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula [NCT04164693]110 participants (Anticipated)Interventional2019-01-01Recruiting
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) [NCT00182143]Phase 33,659 participants (Actual)Interventional2006-05-31Completed
Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care [NCT00655122]Phase 48 participants (Actual)Interventional2003-04-30Terminated(stopped due to See Detailed Description.)
Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up [NCT04593654]257 participants (Actual)Observational2020-03-01Completed
Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study) [NCT00480636]102 participants (Actual)Observational2007-06-30Completed
A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function [NCT00790842]Phase 1/Phase 263 participants (Actual)Interventional2009-01-21Terminated(stopped due to Slow enrollment)
Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma [NCT00577096]120 participants (Actual)Interventional2001-10-31Completed
Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery [NCT00786474]Phase 31,884 participants (Actual)Interventional2009-07-31Completed
A 6 Month, Prospective, Open-Label Multiple Center Extension Trial To Evaluate The Long Term Safety And Sustained Efficacy Of Fragmin In The Treatment Of Chronic Foot Ulcers In Diabetic Patients With Peripheral Arterial Occlusive Disease [NCT00765063]Phase 2/Phase 362 participants (Actual)Interventional2008-10-31Completed
Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen [NCT00681785]250 participants (Actual)Interventional2006-06-30Completed
A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM] [NCT00462852]Phase 2120 participants (Anticipated)Interventional2003-04-30Completed
Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy [NCT00435487]Phase 4173 participants (Actual)Interventional2007-06-30Terminated(stopped due to See termination reason in detailed description.)
A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme [NCT00028678]Phase 245 participants (Actual)Interventional2002-07-11Completed
Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism [NCT00711308]Phase 4102 participants (Actual)Interventional2005-04-30Completed
Comparison of Topical Tranexamic Acid and Floseal® on Blood Loss After Total Knee Arthroplasty in Patients With a Thromboembolic Risk [NCT02865174]Phase 490 participants (Anticipated)Interventional2016-09-30Not yet recruiting
A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss [NCT00564174]88 participants (Actual)Interventional2000-03-31Terminated(stopped due to interim analysis found no difference in LB rate and lower than expected event rate)
Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight? [NCT01390051]Phase 450 participants (Actual)Interventional2011-07-31Completed
Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers [NCT04394182]15 participants (Anticipated)Interventional2020-04-21Suspended(stopped due to lack of recruitment)
Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study. [NCT02746185]Phase 3159 participants (Actual)Interventional2016-09-30Completed
Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy [NCT04645550]Phase 4120 participants (Actual)Interventional2020-11-22Completed
A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients [NCT00876915]Phase 3218 participants (Actual)Interventional2009-07-31Terminated(stopped due to slow enrollment and lack of continuing funds)
Combined Administration of Inhaled DNase, Baricitinib and Tocilizumab as Rescue Treatment in Severe COVID-19 Patients [NCT05279391]150 participants (Anticipated)Interventional2020-10-25Recruiting
FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer [NCT00519805]Phase 32,200 participants (Anticipated)Interventional2007-08-31Recruiting
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer [NCT00981903]Phase 2131 participants (Actual)Interventional2005-07-31Terminated(stopped due to Tinzaparin will no longer be available in the United States)
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot) [NCT00182364]Phase 3120 participants Interventional2003-02-28Completed
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome [NCT00932100]Phase 2640 participants (Actual)Interventional2009-07-31Completed
Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients. [NCT00445328]Phase 484 participants (Actual)Interventional2007-06-30Terminated(stopped due to See Detailed Description)
A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure [NCT01086046]450 participants (Anticipated)Interventional2009-01-31Recruiting
A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS) [NCT00239980]Phase 277 participants (Actual)Interventional2005-10-31Completed
Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial) [NCT01930396]Phase 4191 participants (Actual)Interventional2013-09-30Completed
The Cesarean Section Thromboprophylaxis Pilot Study:A Randomized Open-Label Controlled Pilot Study of Prophylactic Low Molecular Weight Heparin in High Risk Postpartum Women Following Cesarean Section [NCT00225108]Phase 2/Phase 330 participants Interventional2002-07-31Completed
Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer. [NCT01945879]Phase 1/Phase 219 participants (Actual)Interventional2003-01-31Completed
Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment. [NCT00966277]Phase 487 participants (Actual)Interventional2010-04-30Completed
Efficacy and Safety Study to Evaluate the Use of Nebulized Heparin in Patients With Severe Acute Respiratory Syndrome Covid-19 (SARS-CoV-2) [NCT04530578]Phase 4200 participants (Anticipated)Interventional2020-06-01Recruiting
Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients. [NCT04671160]80 participants (Anticipated)Observational [Patient Registry]2021-01-04Not yet recruiting
Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery [NCT00726570]40 participants (Actual)Interventional2008-08-31Terminated(stopped due to Failed to reach the expected enrollment rates by the end of 2010)
A Multicenter Randomized Double-blind Placebo-controlled Prospective Study to Evaluate the Safety and Efficacy of the Direct Factor Xa Inhibitor Dimolegin (DD217) in Prevention of Venous Thromboembolic Complications During Knee Replacement [NCT05189002]Phase 2240 participants (Actual)Interventional2019-05-31Active, not recruiting
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients: A Prospective Study [NCT02607111]Phase 415 participants (Actual)Interventional2016-08-31Completed
Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia [NCT02645240]Phase 497 participants (Actual)Interventional2015-10-31Completed
Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis [NCT00689520]Phase 4241 participants (Actual)Interventional2002-01-31Completed
Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome Phase IV Pilot Study [NCT04794569]Phase 460 participants (Anticipated)Interventional2021-11-15Recruiting
The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI [NCT02658838]Phase 4300 participants (Anticipated)Interventional2015-04-30Active, not recruiting
A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism ( [NCT00986154]Phase 38,292 participants (Actual)Interventional2009-10-31Completed
Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis [NCT04741464]12 participants (Anticipated)Interventional2021-02-02Recruiting
A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES [NCT00952380]Phase 238 participants (Actual)Interventional2009-08-31Completed
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis [NCT04269954]Phase 460 participants (Anticipated)Interventional2020-03-01Not yet recruiting
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome [NCT04850378]Phase 1/Phase 280 participants (Anticipated)Interventional2021-03-25Recruiting
A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Fragmin (5,000 IU Subcutaneously) in Preventing Catheter-Related Complications When Given Daily to Cancer Patients With Central Venous Catheters [NCT00006083]Phase 30 participants Interventional2000-04-30Completed
Weight-Adjusted Dosing of Tinzaparin in Pregnancy [NCT00851864]Phase 413 participants (Actual)Interventional2007-10-31Completed
A Randomized Trial of the Effect of Low-Molecular-Weight Heparin Versus Warfarin Sodium on the Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (Main LITE Study) [NCT00203580]Phase 4910 participants Interventional1994-12-31Completed
Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss [NCT00400387]Phase 3449 participants (Actual)Interventional2006-11-30Completed
LITE Study, Appendix A (HOME-LITE), Amendment 6 [NCT00203658]Phase 4400 participants Interventional1997-04-30Completed
Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension [NCT05304455]40 participants (Actual)Interventional2022-04-01Completed
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery [NCT01046903]503 participants (Actual)Observational2010-03-31Completed
Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden [NCT04412304]166 participants (Actual)Observational2020-03-06Completed
An Evaluation of the Clinical Utility of Thrombelastography (TEG) in Guiding Low Molecular Weight Heparin (LMWH) and Antiplatelet Prophylaxis of Venous Thromboembolism (VTE) Following Trauma [NCT01050153]50 participants (Actual)Interventional2010-03-31Completed
Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration. [NCT01692171]Phase 132 participants (Actual)Interventional2013-02-28Completed
Residual Vein Thrombosis Establishes the Optimal Duration of Low Molecular Weight Heparins in Cancer Patients With Deep Vein Thrombosis of the Lower Limbs [NCT00450645]Phase 4300 participants (Anticipated)Interventional2005-03-31Recruiting
Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial. [NCT00475098]Phase 3553 participants (Actual)Interventional2007-06-30Completed
Prospective, Randomized, Double-blinded Trial of the Efficacy and Safety of Different Doses and Duration of Low Molecular Weight Heparin (Dalteparin) in Superficial Vein Thrombosis [NCT01245998]Phase 468 participants (Actual)Interventional2010-12-01Completed
Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China [NCT02935530]Phase 3315 participants (Actual)Interventional2016-01-31Completed
Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment. [NCT02834559]Phase 3326 participants (Actual)Interventional2016-10-27Completed
Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Subcutaneous Administration. [NCT01692158]Phase 136 participants (Actual)Interventional2013-03-31Completed
Anti Xa Blood Levels at Survivors of Acute Ischemic Stroke- Receiving LMWH-VTE Prophylaxis [NCT03593291]100 participants (Anticipated)Observational2018-11-01Not yet recruiting
A Prospective, Randomized, Open-label Study to Evaluate the Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization Procedures [NCT04196309]Phase 460 participants (Actual)Interventional2017-05-25Completed
Early Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia: A Phase IIb Trial [NCT04990830]Phase 2/Phase 380 participants (Actual)Interventional2021-02-03Completed
Treatment of Upper Extremity Deep-Vein Thrombosis [NCT00245856]Phase 467 participants (Actual)Interventional2002-09-30Completed
Evaluating Body Size Descriptors on Peak Anti-Xa Levels in Bariatric Surgery Obese Patients Receiving Low Molecular Weight Heparin Fixed Doses [NCT03218514]118 participants (Actual)Observational2014-07-31Completed
Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension [NCT02247414]Phase 4124 participants (Actual)Interventional2014-09-30Completed
Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration, a Randomized Controlled Trial Comparing Anticoagulation With Citrate to the Low Molecular Weight Heparin Nadroparin [NCT00286273]Phase 4215 participants (Actual)Interventional2003-03-31Completed
Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care [NCT00399425]Phase 2/Phase 384 participants Interventional2001-06-30Terminated
A Randomized Pilot Study of the Activation of the Hemostatic Pathway by FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer [NCT00323011]Phase 25 participants (Actual)Interventional2006-05-31Terminated(stopped due to drug not available)
A Double Blind Randomized Control Trial of Post-Operative Low Molecular Weight Heparin Bridging Therapy Versus Placebo Bridging Therapy for Patients Who Are at High Risk for Arterial Thromboembolism (PERIOP 2) [NCT00432796]Phase 31,473 participants (Actual)Interventional2006-12-31Active, not recruiting
A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE) [NCT00135876]Phase 3512 participants Interventional2002-10-31Completed
Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT) [NCT00138099]140 participants (Actual)Observational2004-07-31Completed
Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis [NCT00135863]36 participants Interventional2004-05-31Terminated
Objective Assessment of Pulmonary Embolism Can be Deferred Without Increased Risk [NCT00381511]Phase 4300 participants Interventional1999-01-31Completed
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial [NCT04344756]Phase 2808 participants (Anticipated)Interventional2020-04-20Not yet recruiting
D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia [NCT04584580]Phase 450 participants (Anticipated)Interventional2020-08-01Recruiting
A Phase 2 Study of Lenalidomide and Low-dose Dexamethasone in Combination With Dalteparin in Previously Untreated Multiple Myeloma [NCT01518465]Phase 213 participants (Actual)Interventional2012-01-09Terminated(stopped due to Insufficient Accrual)
Low Dose Rt-PA Plus LMWH Compared With LMWH Alone for the Treatment of Normotensive Pulmonary Embolism Patients With Acute RV Dysfunction: A Randomized,Multi-Center,Controlled Trial [NCT01531829]Phase 4460 participants (Anticipated)Interventional2009-07-31Recruiting
Double-blinded, Randomized Trial in Severe Pneumonia Patients With Severe Sepsis Investigating the Safety and Efficacy of Co-administration of Iloprost and Ascending Doses of Eptifibatide Compared to Low-molecular-weight Heparin [NCT01532544]Phase 25 participants (Actual)Interventional2012-06-30Terminated(stopped due to Difficulty recruiting patients, company closed down)
STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism [NCT04727437]Phase 31,466 participants (Anticipated)Interventional2021-04-08Recruiting
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer [NCT00031837]Phase 3400 participants (Anticipated)Interventional2002-10-31Terminated
Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients [NCT00041782]Phase 226 participants (Actual)Interventional2000-10-31Terminated
A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated) [NCT00049777]Phase 42,000 participants Interventional2002-12-31Completed
PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients [NCT02984384]Phase 312,211 participants (Actual)Interventional2017-04-24Completed
"Effects of Tinzaparin Sodium on Cardio-vascular OUtcomes and on Blood Lipids in Diabetic Patients on Chronic HEmodialysis: A Long-term, Prospective Study (The Tinzaparin COULD HELP Study)." [NCT00407641]Phase 40 participants (Actual)Interventional2009-03-31Withdrawn(stopped due to Financial and administrative matters did not allow collaboration among centers.)
Tinzaparin for Treatment of Venous Thromboembolism in Renal Insufficiency: A Pilot Study [NCT00186745]148 participants (Actual)Interventional2005-03-31Terminated(stopped due to Funding ceased)
Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention [NCT00187408]Phase 4700 participants Interventional2002-08-31Completed
Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction [NCT03171727]117 participants (Anticipated)Interventional2017-06-01Recruiting
Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial [NCT05067153]Phase 4100 participants (Anticipated)Interventional2021-05-01Recruiting
[NCT00371020]Phase 30 participants Interventional2005-02-28Active, not recruiting
Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC [NCT06020560]Phase 465,000 participants (Anticipated)Interventional2023-03-23Recruiting
Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation [NCT00260520]0 participants Observational2002-01-31Terminated
Tinzaparin Versus Dalteparin for Perioperative Thromboembolic Prophylaxis in Patients With Dialysis Dependent Renal Disease- A Canadian Multicentre Trial [NCT00260988]Phase 2/Phase 329 participants (Actual)Interventional2003-10-31Completed
Cervical Artery Dissection in Stroke Study [NCT00238667]Phase 3250 participants (Actual)Interventional2005-11-30Completed
Heparin Anticoagulation to Improve Outcomes in Septic Shock: The HALO Pilot [NCT01648036]Phase 276 participants (Actual)Interventional2012-07-31Completed
Risk of Hemorrhage in Patients Prescribed Arixtra Compared to LMWH [NCT01064362]13,442 participants (Actual)Observational2010-01-31Completed
A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma [NCT00293501]Phase 1/Phase 235 participants (Anticipated)Interventional2005-12-31Active, not recruiting
A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients [NCT00451412]Phase 33,254 participants (Actual)Interventional2007-01-31Completed
Prolonged Hypercoagulability Following Major Liver Resection for Malignancy [NCT06153394]Phase 350 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study [NCT04380818]106 participants (Anticipated)Interventional2020-06-05Recruiting
[NCT01626911]60 participants (Anticipated)Interventional2011-09-30Recruiting
A Randomized Clinical Trial of Using Preconceptional Enoxaparin AND Low Dose Aspirin 81mg in Patient With Antiphospholipid Syndrome(APS) [NCT01661439]316 participants (Anticipated)Observational2012-03-31Recruiting
A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin [NCT01714297]Phase 480 participants (Actual)Interventional2008-01-31Completed
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427]695 participants (Actual)Observational2012-11-30Completed
Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial [NCT01741506]Phase 4116 participants (Actual)Interventional2013-03-31Completed
Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty [NCT01770769]220 participants (Actual)Interventional2012-02-06Active, not recruiting
A Feasibility Study to Inform the Design of a Randomised Controlled Trial to Identify the Most Clinically and Cost Effective Length of Anticoagulation With Low Molecular Weight Heparin In the Treatment of Cancer Associated Thrombosis [NCT01817257]Phase 22 participants (Actual)Interventional2013-12-31Terminated(stopped due to Early findings showed trial was not feasible)
Management of Superficial Thrombophlebitis [NCT00264381]Phase 472 participants (Actual)Interventional2002-10-31Completed
Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism [NCT03862755]Phase 4581 participants (Actual)Interventional2017-08-08Completed
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE) [NCT05150938]5,737 participants (Actual)Observational2022-03-18Completed
A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism in Patients With Advanced Upper Gastrointestinal, Hepatobiliary and Pancrea [NCT03139487]Phase 2176 participants (Anticipated)Interventional2017-08-07Recruiting
Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study. [NCT03465735]15 participants (Actual)Interventional2017-01-13Terminated(stopped due to Due to lack of recruitment of eligible participants)
Anti-Xa Assay Correlation to the Efficacy and Safety of Enoxaparin in the Treatment of Pulmonary Embolism [NCT02977013]42 participants (Actual)Observational2013-08-31Completed
Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer [NCT03090880]Phase 359 participants (Actual)Interventional2018-09-14Terminated(stopped due to "The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives.~The sponsor has decided to prematurely stop inclusions on January 13, 2022.")
Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery [NCT01444612]4,068 participants (Actual)Observational2010-02-28Completed
Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients [NCT01448746]Phase 3682 participants (Actual)Interventional2011-10-31Active, not recruiting
A Multicentre Prospective Cohort Study Assessing the Use of Weight-Adjusted Low-Molecular-Weight-Heparin in Patients Over 90 kg With Acute Cancer-Associated Venous Thromboembolism [NCT03297359]Phase 2150 participants (Anticipated)Interventional2018-03-21Recruiting
Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto [NCT04393805]744 participants (Actual)Observational2020-06-01Completed
Observation and Treatment of Pulmonary Microthrombosis in Childhood Pneumonia With Elevated D-dimer [NCT04778917]Phase 4124 participants (Actual)Interventional2014-12-31Completed
Phase I Study of Dalteparin, A Low Molecular Weight Heparin (LMWH), in Combination With Sunitinib (SU11248), an Oral, Selective Multi-targeted Tyrosine Kinase Inhibitor, as First Line Treatment, in Patients With Metastatic Renal Cell Carcinoma [NCT01061411]Phase 116 participants (Actual)Interventional2010-02-06Completed
Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST) [NCT00061373]Phase 218 participants (Actual)Interventional2003-05-31Completed
Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis [NCT02414802]40 participants (Anticipated)Interventional2014-12-31Enrolling by invitation
Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. [NCT05554055]150 participants (Anticipated)Observational2022-11-30Not yet recruiting
Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices [NCT05545475]100 participants (Anticipated)Observational2022-01-01Recruiting
A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism [NCT02585713]Phase 3300 participants (Actual)Interventional2015-11-20Completed
Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle. [NCT01924104]Phase 3400 participants (Anticipated)Interventional2013-08-31Recruiting
Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves [NCT04450446]100 participants (Anticipated)Observational2015-01-01Recruiting
Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer [NCT00003674]Phase 3141 participants (Actual)Interventional1998-12-31Completed
Pre- vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial [NCT04731558]Phase 41,012 participants (Anticipated)Interventional2021-02-10Recruiting
Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID) [NCT04730856]311 participants (Actual)Interventional2021-02-01Completed
Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis [NCT01999179]27 participants (Actual)Interventional2014-06-30Completed
ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial [NCT04808882]Phase 2353 participants (Actual)Interventional2021-04-14Completed
To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation [NCT04741295]70 participants (Anticipated)Interventional2020-02-01Active, not recruiting
Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED) [NCT03099031]420 participants (Actual)Observational2015-05-31Completed
[NCT00370760]Phase 30 participants Interventional2006-09-30Recruiting
A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss [NCT03100123]Early Phase 11 participants (Actual)Interventional2017-11-06Terminated(stopped due to Pilot deemed not feasible by Steering Committee due to recruitment rate.)
Effect of Anti Xa Monitoring Low Molecular Weight Heparin (LMWH) on Prevention of Venous Thromboembolism in Critically Ill Patients:A Randomized Controlled Trial [NCT05382481]858 participants (Anticipated)Interventional2022-05-16Recruiting
A Study to Assess the Effectiveness of Dry Cold Application on Pain Intensity and Bruise at the Subcutaneous Injection Site Among Patients Admitted in Selected Hospital [NCT03233321]60 participants (Actual)Interventional2015-11-30Completed
A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer [NCT02073682]Phase 31,046 participants (Actual)Interventional2015-07-16Completed
A Proposal of a Prospective Study on Prevention of Pregnancy Loss in Women Carrying Inherited Thrombophilia [NCT02385461]108 participants (Anticipated)Observational [Patient Registry]2012-01-31Recruiting
Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses [NCT01828697]Phase 41,110 participants (Actual)Interventional2013-04-24Completed
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort [NCT04979780]3,708 participants (Actual)Observational2021-07-20Completed
Extended Low-Molecular Weight Heparin VTE Prophylaxis in the Thoracic Surgery Population, a Prospective, Randomized Controlled Study [NCT02334007]Phase 1/Phase 2102 participants (Actual)Interventional2015-09-30Completed
DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study [NCT00525057]65 participants (Actual)Interventional2006-07-07Completed
Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT) [NCT04946929]Phase 350 participants (Anticipated)Interventional2021-07-31Not yet recruiting
Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19) [NCT04359212]90 participants (Actual)Observational2020-05-01Completed
Pre- vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial) [NCT05245877]Phase 4800 participants (Anticipated)Interventional2022-08-17Recruiting
Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation [NCT03591471]Phase 1/Phase 2500 participants (Anticipated)Interventional2014-09-30Recruiting
Anti-Xa Activity in Patients Receiving Different Vasopressors. [NCT06055907]50 participants (Anticipated)Observational2023-05-15Recruiting
PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial [NCT03559114]Phase 31,100 participants (Anticipated)Interventional2018-07-19Recruiting
A Multicenter, Randomized, Controlled, Double-Blind Trial to Investigate the Clinical Efficacy and Tolerability of Early Treatment With Simvastatin 40 mg Daily for 30 Days, Followed by Simvastatin 80 mg Daily Thereafter in Tirofiban-Treated Acute Coronary [NCT00251576]Phase 34,497 participants (Actual)Interventional1999-11-01Completed
Randomized Double Blind Placebo Controlled Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose LMWH Versus Placebo [NCT01419977]Phase 234 participants (Actual)Interventional2011-05-31Completed
Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women [NCT03365466]200 participants (Anticipated)Observational2017-12-31Not yet recruiting
A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer [NCT01455831]Phase 3616 participants (Actual)Interventional2011-09-30Completed
STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis [NCT05255003]Phase 450 participants (Anticipated)Interventional2022-08-29Recruiting
Catheter-Directed Thrombolysis Versus ANticoagulation Monotherapy in Patients With Acute Intermediate-High Risk PulmonarY Embolism: The CANARY Randomized Clinical Trial [NCT05172115]Phase 394 participants (Actual)Interventional2018-12-22Terminated(stopped due to Due to the COVID-19 pandemic)
Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards [NCT03157843]1,000 participants (Anticipated)Observational2015-02-28Recruiting
Comparison of Clinical Pregnancy Rates Between Two Protocols, With or Without Low Molecular Weight Heparin Administration Before Frozen Embryo Transfer in Hormonal Replacement Cycles: a Prospective Randomized Controlled Trial [NCT03120715]Phase 4342 participants (Anticipated)Interventional2016-07-01Recruiting
Treatment of Intrauterine Growth Restriction With Low Molecular Heparin: Randomized Clinical Trial. Tratamiento Del Crecimiento Intrauterino Restringido Precoz Con Heparina de Bajo Peso Molecular: Ensayo clínico Aleatorizado. [NCT03324139]Phase 350 participants (Anticipated)Interventional2017-10-31Not yet recruiting
Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture [NCT03282643]Phase 1/Phase 274 participants (Actual)Interventional2016-02-16Completed
A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19 [NCT04505774]Phase 4880 participants (Actual)Interventional2020-09-04Active, not recruiting
A Prospective Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism [NCT03240120]Phase 399 participants (Anticipated)Interventional2017-09-01Recruiting
A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study [NCT01879618]Phase 3152 participants (Actual)Interventional2013-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00061373 (6) [back to overview]Symptomatic Intracerebral Hemorrhage (ICH)
NCT00061373 (6) [back to overview]Other Serious Adverse Event Related to Study Drug Administration, Including Death.
NCT00061373 (6) [back to overview]Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)
NCT00061373 (6) [back to overview]MRI Selected Arm: Complete Brain Reperfusion
NCT00061373 (6) [back to overview]Bleeding Events
NCT00061373 (6) [back to overview]Major Systemic Hemorrhage
NCT00245856 (3) [back to overview]Bleeding Events
NCT00245856 (3) [back to overview]Percentage of Participants That Died at 3 Months
NCT00245856 (3) [back to overview]New Venous Thromboembolism at 3 Months
NCT00264381 (4) [back to overview]Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.
NCT00264381 (4) [back to overview]Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
NCT00264381 (4) [back to overview]Thrombosis Progression and Venous Thromboembolism (VTE)
NCT00264381 (4) [back to overview]Change From Baseline to Day 14 in Pain Assessment
NCT00435487 (6) [back to overview]Number of Subjects With Stroke
NCT00435487 (6) [back to overview]Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization
NCT00435487 (6) [back to overview]Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization
NCT00435487 (6) [back to overview]Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days
NCT00435487 (6) [back to overview]Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria
NCT00435487 (6) [back to overview]Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
NCT00445328 (7) [back to overview]Thrombocytopenia
NCT00445328 (7) [back to overview]Bleeding - Major or Minor
NCT00445328 (7) [back to overview]Confirmed Thromboembolic Events
NCT00445328 (7) [back to overview]Composite of Objectively Verified Thromboembolic Events
NCT00445328 (7) [back to overview]All Cause Mortality
NCT00445328 (7) [back to overview]Allergic Reactions (Drug-related)
NCT00445328 (7) [back to overview]Stroke - Ischemic or Hemorrhagic
NCT00480636 (5) [back to overview]Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)
NCT00480636 (5) [back to overview]Number of Participants With Recurrent DVT
NCT00480636 (5) [back to overview]Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
NCT00480636 (5) [back to overview]Percent of Participants With and Without Pulmonary Embolism (PE)
NCT00480636 (5) [back to overview]Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
NCT00525057 (3) [back to overview]Number of Participants With Post-operative Wound Complications
NCT00525057 (3) [back to overview]Post-Operative Blood Transfusion
NCT00525057 (3) [back to overview]Number of Participants With Occurrence of Venous Thromboembolism
NCT00577096 (10) [back to overview]Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
NCT00577096 (10) [back to overview]Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
NCT00577096 (10) [back to overview]Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
NCT00577096 (10) [back to overview]Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
NCT00577096 (10) [back to overview]Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
NCT00577096 (10) [back to overview]Number of Stem Cell Collection Attempts (Long Term)
NCT00577096 (10) [back to overview]Number of Stem Cell Collection Attempts (Short Term)
NCT00577096 (10) [back to overview]Total Number of Days of Stem Cell Collection (Long Term)
NCT00577096 (10) [back to overview]Total Number of Days of Stem Cell Collection (Short Term)
NCT00577096 (10) [back to overview]Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
NCT00662831 (14) [back to overview]Transcutaneous Local Tissue Oxygenation (pO2)
NCT00662831 (14) [back to overview]Number of Participants Who Underwent Major and Minor Amputation
NCT00662831 (14) [back to overview]36-Item Short-Form Health Survey (SF-36) Score
NCT00662831 (14) [back to overview]Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages
NCT00662831 (14) [back to overview]Number of All Hemorrhages
NCT00662831 (14) [back to overview]Number of Participants Who Died
NCT00662831 (14) [back to overview]Number of Participants Who Underwent Any Amputation
NCT00662831 (14) [back to overview]Number of Major and Minor Hemorrhages
NCT00662831 (14) [back to overview]Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
NCT00662831 (14) [back to overview]Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing
NCT00662831 (14) [back to overview]Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score
NCT00662831 (14) [back to overview]Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing
NCT00662831 (14) [back to overview]Number of Participants With Intact Skin Healing
NCT00662831 (14) [back to overview]11-point Likert Pain Scale
NCT00765063 (10) [back to overview]Number of Participants Who Underwent Amputation
NCT00765063 (10) [back to overview]11-point Likert Pain Scale
NCT00765063 (10) [back to overview]Number of Trivial Hemorrhages
NCT00765063 (10) [back to overview]Number of Participants With Improved Ulcer Healing
NCT00765063 (10) [back to overview]Number of Minor Hemorrhages
NCT00765063 (10) [back to overview]Number of Major Hemorrhages
NCT00765063 (10) [back to overview]Number of Clinically Relevant Minor Hemorrhages
NCT00765063 (10) [back to overview]Number of All Hemorrhages
NCT00765063 (10) [back to overview]Number of Participants With Intact Skin Healing
NCT00765063 (10) [back to overview]36-Item Short-Form Health Survey (SF-36) Score
NCT00786474 (4) [back to overview]Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism
NCT00786474 (4) [back to overview]Number of Arterial Thromboembolic Events
NCT00786474 (4) [back to overview]Major Bleeding
NCT00786474 (4) [back to overview]Number of Participants With Minor Bleeding
NCT00790842 (6) [back to overview]Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
NCT00790842 (6) [back to overview]Progression-free Survival
NCT00790842 (6) [back to overview]Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
NCT00790842 (6) [back to overview]Duration of Response
NCT00790842 (6) [back to overview]Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
NCT00790842 (6) [back to overview]Overall Survival Time
NCT00876915 (8) [back to overview]Percentage of Patients Who Experienced Clinically Significant Bleeding Events.
NCT00876915 (8) [back to overview]Percentage of Patients With Venous Thromboembolisms
NCT00876915 (8) [back to overview]The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
NCT00876915 (8) [back to overview]The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
NCT00876915 (8) [back to overview]The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
NCT00876915 (8) [back to overview]The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
NCT00876915 (8) [back to overview]The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
NCT00876915 (8) [back to overview]The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
NCT00922766 (6) [back to overview]Number of Participants With Cardiac Arrest- Resuscitated
NCT00922766 (6) [back to overview]Number of Participants With Death or Myocardial Infarction (MI)
NCT00922766 (6) [back to overview]Number of Participants With Heparin Induced Thrombocytopenia
NCT00922766 (6) [back to overview]Number of Participants With Major Bleeding Events
NCT00922766 (6) [back to overview]Number of Participants With Minor Bleeding Events
NCT00922766 (6) [back to overview]Number of Participants With Stroke
NCT00942968 (18) [back to overview]Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings
NCT00942968 (18) [back to overview]Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants
NCT00942968 (18) [back to overview]Number of Participants With Abnormal Physical Examinations Findings
NCT00942968 (18) [back to overview]Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Number of Participants With Fatal Bleeding Events
NCT00942968 (18) [back to overview]Number of Participants With Investigator Identified Major Bleeding Events
NCT00942968 (18) [back to overview]Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
NCT00942968 (18) [back to overview]Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
NCT00942968 (18) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT00942968 (18) [back to overview]Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
NCT00942968 (18) [back to overview]Number of Participants With Clinically Significant Laboratory Abnormalities
NCT00942968 (18) [back to overview]Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
NCT00952380 (31) [back to overview]Absolute Values of Body Temperature of Participants
NCT00952380 (31) [back to overview]Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
NCT00952380 (31) [back to overview]Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
NCT00952380 (31) [back to overview]Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
NCT00952380 (31) [back to overview]Absolute Values of Body Length of Participants
NCT00952380 (31) [back to overview]Absolute Values of Body Length of Participants
NCT00952380 (31) [back to overview]Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
NCT00952380 (31) [back to overview]Number of Participants With Physical Examination Abnormalities of Participants
NCT00952380 (31) [back to overview]Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
NCT00952380 (31) [back to overview]Absolute Values of Height of Participants
NCT00952380 (31) [back to overview]Absolute Values of Height of Participants
NCT00952380 (31) [back to overview]Absolute Values of Height of Participants
NCT00952380 (31) [back to overview]Absolute Values of Respiratory Rate of Participants
NCT00952380 (31) [back to overview]Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
NCT00952380 (31) [back to overview]Absolute Values of Weight of Participants
NCT00952380 (31) [back to overview]Time to First Occurrence of Major Bleeding Event
NCT00952380 (31) [back to overview]Number of Participants With Physical Examination Abnormalities of Participants
NCT00952380 (31) [back to overview]Number of Participants With Physical Examination Abnormalities of Participants
NCT00952380 (31) [back to overview]Number of Participants With Physical Examination Abnormalities of Participants
NCT00952380 (31) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00952380 (31) [back to overview]Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
NCT00952380 (31) [back to overview]Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
NCT00952380 (31) [back to overview]Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
NCT00952380 (31) [back to overview]Percentage of Participants With Major and Minor Bleeding Event
NCT00952380 (31) [back to overview]Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
NCT00952380 (31) [back to overview]Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
NCT00952380 (31) [back to overview]Number of Participants With Laboratory Abnormalities
NCT00952380 (31) [back to overview]Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels
NCT00952380 (31) [back to overview]Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
NCT00952380 (31) [back to overview]Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
NCT00952380 (31) [back to overview]Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
NCT00966277 (1) [back to overview]Number of Participants With Venous Thromboembolic Events (VTE)
NCT00986154 (3) [back to overview]The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
NCT00986154 (3) [back to overview]Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
NCT00986154 (3) [back to overview]Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
NCT01046903 (9) [back to overview]Physician's Assessment of Efficacy of Treatment
NCT01046903 (9) [back to overview]Participant's Global Evaluation of Treatment
NCT01046903 (9) [back to overview]Participant's Dosage Regimen
NCT01046903 (9) [back to overview]Number of Participants With Risk Factors
NCT01046903 (9) [back to overview]Number of Participants With Bleeding
NCT01046903 (9) [back to overview]Administration Schedule of Treatment
NCT01046903 (9) [back to overview]Number of Participants With Thromboembolism
NCT01046903 (9) [back to overview]Number of Participants With Hematoma
NCT01046903 (9) [back to overview]Physician's Assessment of Tolerability of Treatment
NCT01050153 (10) [back to overview]Conventional Coagulation Testing Parameters
NCT01050153 (10) [back to overview]Conventional Coagulation Testing Parameters
NCT01050153 (10) [back to overview]Hypercoagulability
NCT01050153 (10) [back to overview]Incidence of VTE
NCT01050153 (10) [back to overview]International Normalized Ratio (INR)
NCT01050153 (10) [back to overview]Platelet Count
NCT01050153 (10) [back to overview]TEG Parameters
NCT01050153 (10) [back to overview]TEG Parameters
NCT01050153 (10) [back to overview]Conventional Coagulation Testing Parameters
NCT01050153 (10) [back to overview]Conventional Coagulation Testing Parameters
NCT01064362 (2) [back to overview]Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
NCT01064362 (2) [back to overview]Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
NCT01274637 (6) [back to overview]Death From Venous Thromboembolism
NCT01274637 (6) [back to overview]Feasibility of Recruitment and Trial Operations.
NCT01274637 (6) [back to overview]Heparin Induced Thrombocytopenia
NCT01274637 (6) [back to overview]Late Symptomatic Venous Thromboembolism
NCT01274637 (6) [back to overview]Major Bleeding or Clinically Relevant Non-major Bleeding
NCT01274637 (6) [back to overview]Venous Thromboembolism in the Early Postpartum Period.
NCT01419977 (4) [back to overview]Change in Clinical Pain Scores
NCT01419977 (4) [back to overview]Change in Clinical Pain Scores
NCT01419977 (4) [back to overview]Change in D-dimer
NCT01419977 (4) [back to overview]Change in Thrombin Generation Assay - Endogenous Thrombin Potential
NCT01879618 (2) [back to overview]Mean Percent of Successful HD Sessions
NCT01879618 (2) [back to overview]Mean Percent of HD Sessions With an Acceptable Dose
NCT01999179 (5) [back to overview]PTS Assessment Completion
NCT01999179 (5) [back to overview]Number of Participants With Recurrent Thrombosis
NCT01999179 (5) [back to overview]Number of Participants With Post-thrombotic Syndrome
NCT01999179 (5) [back to overview]Number of Participants With Major Bleeding
NCT01999179 (5) [back to overview]Biomarker Sample Collection
NCT02073682 (7) [back to overview]Number of Participants With VTE-Related Death
NCT02073682 (7) [back to overview]Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death
NCT02073682 (7) [back to overview]Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
NCT02073682 (7) [back to overview]Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
NCT02073682 (7) [back to overview]Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
NCT02073682 (7) [back to overview]Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
NCT02073682 (7) [back to overview]Number of Participants With Adjudicated Major Bleeding Events While on Treatment
NCT02585713 (3) [back to overview]Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
NCT02585713 (3) [back to overview]6 Month Bleeding Rate
NCT02585713 (3) [back to overview]Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
NCT02744092 (11) [back to overview]Cumulative Rates of Major Bleeding
NCT02744092 (11) [back to overview]Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02774265 (3) [back to overview]Number of Participants With Deep Venous Thromboembolism
NCT02774265 (3) [back to overview]Number of Participants With Pulmonary Embolism Events
NCT02774265 (3) [back to overview]Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.
NCT02981472 (15) [back to overview]The Number of Participants With Adjudicated CRNM Bleeding
NCT02981472 (15) [back to overview]The Number of Participant Deaths in the Study
NCT02981472 (15) [back to overview]The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
NCT02981472 (15) [back to overview]Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
NCT02981472 (15) [back to overview]Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
NCT02981472 (15) [back to overview]Maximum Observed Concentration (Cmax)
NCT02981472 (15) [back to overview]The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
NCT02981472 (15) [back to overview]The Number of Participants With Adjudicated Major Bleeding
NCT02981472 (15) [back to overview]Chromogenic FX Assay (Apparent FX Level)
NCT02981472 (15) [back to overview]Anti-FXa Activity
NCT02981472 (15) [back to overview]Trough Observed Concentration (Cmin)
NCT02981472 (15) [back to overview]Time of Maximum Observed Concentration (Tmax)
NCT02981472 (15) [back to overview]The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
NCT02981472 (15) [back to overview]The Number of Participants With All Adjudicated Bleeding
NCT02981472 (15) [back to overview]Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
NCT03100123 (7) [back to overview]Consent
NCT03100123 (7) [back to overview]Crossover Rate
NCT03100123 (7) [back to overview]Eligibility
NCT03100123 (7) [back to overview]Essential Documents
NCT03100123 (7) [back to overview]Study Drug Compliance
NCT03100123 (7) [back to overview]Study Feasibility: Mean Recruitment Rate Per Center Per Month
NCT03100123 (7) [back to overview]Withdrawals/Loss to Follow-up
NCT03862755 (2) [back to overview]Provider Adherence in Implementation of PE Prevention Strategies.
NCT03862755 (2) [back to overview]Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.
NCT04401293 (7) [back to overview]Re-hospitalization
NCT04401293 (7) [back to overview]Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days.
NCT04401293 (7) [back to overview]Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4
NCT04401293 (7) [back to overview]Major Bleeding
NCT04401293 (7) [back to overview]Need for Intubation
NCT04401293 (7) [back to overview]Progression to Acute Respiratory Distress Syndrome (ARDS)
NCT04401293 (7) [back to overview]Sepsis-induced Coagulopathy (SIC) Score

Symptomatic Intracerebral Hemorrhage (ICH)

"This is a primary safety outcome or toxicity measure for all subjects.~Symptomatic ICH is defined as the presence of two conditions: evidence of hemorrhage on the 72-hour head CT and an increase in the NIHSS score of 4 or more points from the prior examination. Hemorrhage classifications are according to European Cooperative Acute Stroke Study (ECASS).~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms." (NCT00061373)
Timeframe: From the start of study drugs and prior to the 72-hour safety head CT

Interventionparticipants (Number)
MRI- Selected Patients1
Non-MRI Selected Patients1

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Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)

"This is the primary response outcome measure for subjects in the non-MRI arm. A positive response is measured by a 7 point or more improvement in the NIHSS or for those with less than 7 points at baseline,complete resolution of stroke symptoms.~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms." (NCT00061373)
Timeframe: up to 24 hours from the start of study drugs

Interventionparticipants (Number)
MRI- Selected Patients3
Non-MRI Selected Patients2

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MRI Selected Arm: Complete Brain Reperfusion

This is the primary response outcome measure for patients in the MRI arm. A positive response is measured by evidence of complete reperfusion (or restoration of blood flow)on the perfusion weighted images (PWI) and mean transit time (MTT) maps of MRIs at 2 hours and sustained at 24 hours. (NCT00061373)
Timeframe: up to 24 hours from the start of study drugs

Interventionparticipants (Number)
MRI- Selected Patients0

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Bleeding Events

Bleeding events of any type, severity and at any time throughout the 30-day trial period. (NCT00061373)
Timeframe: 2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs

Interventionparticipants (Number)
MRI- Selected Patients8
Non-MRI Selected Patients1

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Major Systemic Hemorrhage

Major systemic hemorrhage is defined bleeding associated with an adjusted decrease in hemoglobin of greater than 5 grams per diluent (g/dL), or and adjusted decrease in hematocrit greater than or equal to 15 percentage points or bleeding causing persistent or significant disability or incapacity such as hemorrhage in the eye. (NCT00061373)
Timeframe: From the start of study drugs and prior to 72-hour head CT

Interventionparticipants (Number)
MRI- Selected Patients0
Non-MRI Selected Patients0

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Bleeding Events

Total major bleeding rate (NCT00245856)
Timeframe: 3 months

Interventionparticipants (Number)
Dalteparin + Warfarin/Dalteparin Alone1

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Percentage of Participants That Died at 3 Months

(NCT00245856)
Timeframe: 3 months

Interventionpercentage of participants (Number)
All cause mortalityDeaths attributed to DVT/PE
All DVT Treated Patients80

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New Venous Thromboembolism at 3 Months

New DVT or PE at 3 months confirmed by diagnostic testing (NCT00245856)
Timeframe: 3 months

Interventionparticipants (Number)
Dalteparin + Warfarin or Dalteparin Alone0

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Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.

Number of participants with bleeding events related to treatment (NCT00264381)
Timeframe: 3 months

Interventionparticipants (Number)
Ibuprofen 800 mg Tid0
Dalteparin 200 U/kg Then 10,000 U Daily0

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Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months

Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing. (NCT00264381)
Timeframe: 3 months

,
Interventionparticipants (Number)
Thrombosis progressionVTE
Dalteparin 200 U/kg Then 10,000 U Daily41
Ibuprofen 800 mg Tid60

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Thrombosis Progression and Venous Thromboembolism (VTE)

Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing (NCT00264381)
Timeframe: Day 14

,
Interventionparticipants (Number)
Thrombosis progressionVTE
Dalteparin 200 U/kg Then 10,000 U Daily00
Ibuprofen 800 mg Tid40

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Change From Baseline to Day 14 in Pain Assessment

Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain (NCT00264381)
Timeframe: Day 1, Day 14

Interventionunits on a scale (Mean)
Ibuprofen 800 mg Tid-2.28
Dalteparin 200 U/kg Then 10,000 U Daily-2.23

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Number of Subjects With Stroke

Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma). (NCT00435487)
Timeframe: End of hospitalization, Day 30

Interventionparticipants (Number)
Arm A: Dalteparin1
Arm B: Unfractioned Heparin (UFH)0

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Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization

Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically. (NCT00435487)
Timeframe: End of hospitalization, Day 30

Interventionparticipants (Number)
Arm A: Dalteparin0
Arm B: Unfractioned Heparin (UFH)0

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Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization

Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization. (NCT00435487)
Timeframe: End of hospitalization, Day 30

Interventionparticipants (Number)
Arm A: Dalteparin3
Arm B: Unfractioned Heparin (UFH)3

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Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days

Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. (NCT00435487)
Timeframe: End of hospitalization, Day 30

Interventionparticipants (Number)
Arm A: Dalteparin3
Arm B: Unfractioned Heparin (UFH)3

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Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria

Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%. (NCT00435487)
Timeframe: End of hospitalization, Day 30

Interventionparticipants (Number)
Arm A: Dalteparin0
Arm B: Unfractioned Heparin (UFH)0

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Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30

Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. (NCT00435487)
Timeframe: Baseline to Day 30

,
Interventionparticipants (Number)
DeathNon-fatal Myocardial InfarctionDeath or Non-fatal Myocardial Infarction
Arm A: Dalteparin224
Arm B: Unfractioned Heparin (UFH)415

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Thrombocytopenia

Subjects with thrombocytopenia (low platelets). (NCT00445328)
Timeframe: Day 21

Interventionparticipants (Number)
Dalteparin35
Unfractionated Heparin31

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Bleeding - Major or Minor

Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor. (NCT00445328)
Timeframe: Day 21

,
Interventionparticipants (Number)
Major BleedingMinor Bleeding
Dalteparin00
Unfractionated Heparin10

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Confirmed Thromboembolic Events

Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms. (NCT00445328)
Timeframe: Day 21

,
Interventionparticipants (Number)
PresentAbsent
Dalteparin037
Unfractionated Heparin035

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Composite of Objectively Verified Thromboembolic Events

Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'. (NCT00445328)
Timeframe: Day 21

,
Interventionparticipants (Number)
Symptomatic DVT PresentSymptomatic DVT AbsentSymptomatic Proximal DVT PresentSymptomatic Proximal DVT AbsentSymptomatic Distal DVT PresentSymptomatic Distal DVT AbsentAsymptomatic Proximal DVT PresentAsymptomatic Proximal DVT AbsentFatal pulmonary embolism PresentFatal pulmonary embolism AbsentSymptomatic non-fatal pulmonary embolism PresentSymptomatic non-fatal pulmonary embolism AbsentSudden Death within 24 hours of VTE PresentSudden Death within 24 hours of VTE Absent
Dalteparin037037037037037037037
Unfractionated Heparin035035035035035035035

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All Cause Mortality

Subjects with death from any cause: end of study. (NCT00445328)
Timeframe: Day 14, Day 21 (End of Study)

Interventionparticipants (Number)
Dalteparin0
Unfractionated Heparin1

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Allergic Reactions (Drug-related)

Subjects with drug-related allergic reactions (NCT00445328)
Timeframe: Day 21

Interventionparticipants (Number)
Dalteparin0
Unfractionated Heparin0

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Stroke - Ischemic or Hemorrhagic

Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography (NCT00445328)
Timeframe: Day 21

Interventionparticipants (Number)
Dalteparin0
Unfractionated Heparin0

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Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)

Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment. (NCT00480636)
Timeframe: Baseline through Month 6 or EOT (up to Month 6)

InterventionParticipants (Number)
Dalteparin0

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Number of Participants With Recurrent DVT

Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits (NCT00480636)
Timeframe: Month 6 or EOT (up to Month 6)

InterventionParticipants (Number)
Dalteparin3

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Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg

Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg (NCT00480636)
Timeframe: Month 6 or End of Treatment (EOT) (up to Month 6)

InterventionParticipants (Number)
Dalteparin43

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Percent of Participants With and Without Pulmonary Embolism (PE)

PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy) (NCT00480636)
Timeframe: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)

InterventionPercent of participants (Number)
Baseline with PE (n = 16)Baseline without PE (n = 82)Baseline with missing information (n = 4)Week 2 with PE (n = 7)Week 2 without PE (n = 85)Week 2 with missing information (n = 10)Month 1 with PE (n = 3)Month 1 without PE (n = 96)Month 1 with missing information (n = 3)Month 3 with PE (n = 1)Month 3 without PE (n = 91)Month 3 with missing information (n = 10)Month 6 or EOT with PE (n = 3)Month 6 or EOT without PE (n = 85)Month 6 or EOT with missing information (n = 14)
Dalteparin15.780.43.96.983.39.82.994.12.91.089.29.82.983.313.7

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Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood

Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment. (NCT00480636)
Timeframe: Baseline through Month 6 or EOT (up to Month 6)

InterventionParticipants (Number)
Dalteparin0

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Number of Participants With Post-operative Wound Complications

Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma. (NCT00525057)
Timeframe: 4 weeks after surgery

,
InterventionParticipants (Count of Participants)
SeromaWound InfectionWound Dehiscence
Interventional (Dalteparin, Metastatic)100
Interventional (Dalteparin, Sarcoma)431

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Post-Operative Blood Transfusion

The volume of packed red blood cell transfusion in the post-operative period (NCT00525057)
Timeframe: 4 weeks after surgery

InterventionmL (Mean)
Interventional (Dalteparin, Metastatic)213
Interventional (Dalteparin, Sarcoma)271

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Number of Participants With Occurrence of Venous Thromboembolism

A secondary outcome was the occurrence of venous thrombolembolism in the post-operative period, to include both deep venous thrombosis in the lower extremity as well as pulmonary embolism. (NCT00525057)
Timeframe: 4 weeks after surgery

,
InterventionParticipants (Count of Participants)
Deep venous thrombosisPulmonary embolism
Interventional (Dalteparin, Metastatic)10
Interventional (Dalteparin, Sarcoma)00

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Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 15 weeks

,
Interventiong/dl (Mean)
BaselineBefore transplantationDuring transplantationAt discharge
Exercise11.611.010.410.6
Usual Care12.110.810.110.6

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Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 15 weeks

InterventionRBC Transfusions (Mean)
Usual Care2.3
Exercise1.8

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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionPlatelet Transfusions (Mean)
Usual Care3.6
Exercise2.0

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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionPlatelet transfusions (Mean)
Usual Care3.1
Exercise2.3

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Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 30 weeks

InterventionRBC Transfusions (Mean)
Usual Care1.8
Exercise1.0

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Number of Stem Cell Collection Attempts (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionStem Cell Collection Attempts (Mean)
Usual Care1.3
Exercise1.1

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Number of Stem Cell Collection Attempts (Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionStem Cell Collection Attempts (Mean)
Usual Care1.4
Exercise1.1

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Total Number of Days of Stem Cell Collection (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionDays (Mean)
Usual Care4.9
Exercise4.5

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Total Number of Days of Stem Cell Collection (Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionDays (Mean)
Usual Care5.3
Exercise4.0

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Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 30 weeks

,
Interventiong/dl (Mean)
BaselineBefore TransplantationDuring TransplanationAt Discharge
Exercise11.712.010.811.0
Usual Care11.512.010.810.9

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Transcutaneous Local Tissue Oxygenation (pO2)

Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell. (NCT00662831)
Timeframe: Baseline and Week 24 (EOT or early termination)

,
InterventionUnits on a scale (Mean)
BaselineEOT (n= 32, 19)
Dalteparin31.8038.80
Placebo36.0039.70

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Number of Participants Who Underwent Major and Minor Amputation

A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

,
Interventionparticipants (Number)
Major amputationMinor amputation
Dalteparin27
Placebo11

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36-Item Short-Form Health Survey (SF-36) Score

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). (NCT00662831)
Timeframe: Baseline and Week 24 (EOT or early termination)

,
InterventionUnits on a scale (Mean)
Baseline: Physical FunctioningBaseline: Role-PhysicalBaseline: Bodily PainBaseline: General HealthBaseline: VisibilityBaseline: Social FunctioningBaseline: Role-EmotionalBaseline: Mental HealthBaseline: Physical (PCS)Baseline: Mental (MCS)EOT: Physical Functioning (n= 156, 76)EOT: Role-Physical (n= 155, 76)EOT: Bodily Pain (n= 156, 76)EOT: General Health (n= 156, 76)EOT: Visibility (n= 156, 76)EOT: Social Functioning (n= 152, 73)EOT: Role-Emotional (n= 155, 76)EOT: Mental Health (n= 156, 76)EOT: Physical (PCS) (n= 151, 73)EOT: Mental (MCS) (n= 151, 73)
Dalteparin34.7035.4042.3042.3048.3033.0039.1041.9038.1042.4037.1039.3047.5042.5048.2033.3041.2041.9041.7042.10
Placebo32.5035.2040.3042.6048.7033.1038.3041.3036.7042.8035.5037.5045.0042.8048.8032.3038.8042.0040.1041.60

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Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages

Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

,
Interventionhemorrhages (Number)
Clinically relevant minor hemorrhagesTrivial hemorrhages
Dalteparin53
Placebo11

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Number of All Hemorrhages

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

Interventionhemorrhages (Number)
Dalteparin10
Placebo2

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Number of Participants Who Died

(NCT00662831)
Timeframe: Week 24 (EOT) or early termination

Interventionparticipants (Number)
Dalteparin4
Placebo3

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Number of Participants Who Underwent Any Amputation

Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

Interventionparticipants (Number)
Dalteparin8
Placebo2

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Number of Major and Minor Hemorrhages

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

,
Interventionhemorrhages (Number)
Major hemorrhagesMinor hemorrhages
Dalteparin28
Placebo02

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Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. (NCT00662831)
Timeframe: Baseline and Week 24 (EOT or early termination)

,
Interventionmm (Mean)
BaselineEOT (n= 157, 76)
Dalteparin60.2063.30
Placebo55.3060.70

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Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing

University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

,
Interventionparticipants (Number)
Stratum 1 (n= 97, 49)Stratum 2 (n= 39, 19)Stratum 3 (n= 29, 14)Stratum 4 (n= 19, 10)
Dalteparin338138
Placebo151062

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Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00662831)
Timeframe: Baseline and Week 24 (EOT or early termination)

,
InterventionUnits on a scale (Mean)
BaselineEOT (n= 154, 74)
Dalteparin0.600.70
Placebo0.600.60

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Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing

University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. (NCT00662831)
Timeframe: Week 24 [end of treatment (EOT)] or early termination

,
Interventionparticipants (Number)
Stratum 1 (n= 97, 49)Stratum 2 (n= 39, 19)Stratum 3 (n= 29, 14)Stratum 4 (n= 19, 10)
Dalteparin6823219
Placebo3114106

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Number of Participants With Intact Skin Healing

Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. (NCT00662831)
Timeframe: Week 24 (EOT) or early termination

,
Interventionparticipants (Number)
Stratum 1 (n= 97, 49)Stratum 2 (n= 39, 19)Stratum 3 (n= 29, 14)Stratum 4 (n= 19, 10)
Dalteparin351581
Placebo16444

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11-point Likert Pain Scale

The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain. (NCT00662831)
Timeframe: Baseline and Week 24 (EOT or early termination)

,
InterventionUnits on a scale (Mean)
BaselineEOT (n= 155, 75)
Dalteparin4.202.10
Placebo4.502.50

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Number of Participants Who Underwent Amputation

A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. (NCT00765063)
Timeframe: Baseline through Week 24 (EOT) or ET

InterventionParticipants (Number)
All amputations (major and minor)Major AmputationMinor Amputation
Dalteparin110

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11-point Likert Pain Scale

The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain. (NCT00765063)
Timeframe: Baseline and Week 24 (EOT) or ET

InterventionUnits on a scale (Mean)
BaselineEOT
Dalteparin2.42.2

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Number of Trivial Hemorrhages

Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding. (NCT00765063)
Timeframe: Baseline to Week 24 (EOT) or ET

InterventionHemorrhages (Number)
Dalteparin1

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Number of Participants With Improved Ulcer Healing

Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs. (NCT00765063)
Timeframe: Baseline through Week 24 (EOT) or ET

InterventionParticipants (Number)
Dalteparin25

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Number of Minor Hemorrhages

Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. (NCT00765063)
Timeframe: Baseline to Week 24 (EOT) or ET

InterventionHemorrhages (Number)
Dalteparin3

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Number of Major Hemorrhages

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). (NCT00765063)
Timeframe: Baseline to Week 24 (EOT) or ET

InterventionHemorrhages (Number)
Dalteparin0

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Number of Clinically Relevant Minor Hemorrhages

Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. (NCT00765063)
Timeframe: Baseline to Week 24 (EOT) or ET

InterventionHemorrhages (Number)
Dalteparin2

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Number of All Hemorrhages

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. (NCT00765063)
Timeframe: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)

InterventionHemorrhages (Number)
Dalteparin3

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Number of Participants With Intact Skin Healing

Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers. (NCT00765063)
Timeframe: Baseline through Week 24 (EOT) or ET

InterventionParticipants (Number)
Dalteparin19

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36-Item Short-Form Health Survey (SF-36) Score

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). (NCT00765063)
Timeframe: Baseline and Week 24 (EOT) or ET

InterventionUnits on a scale (Mean)
Baseline: Physical Functioning (n= 43)Baseline: Role-Physical (n= 43)Baseline: Bodily Pain (n= 43)Baseline: General Health (n= 43)Baseline: Visibility (n= 43)Baseline: Social Functioning (n= 43)Baseline: Role-Emotional (n= 43)Baseline: Mental Health (n= 43)Baseline: Physical (PCS) (n= 43)Baseline: Mental (MCS) (n= 43)EOT: Physical Functioning (n= 57)EOT: Role-Physical (n= 57)EOT: Bodily Pain (n= 57)EOT: General Health (n= 57)EOT: Visibility (n= 57)EOT: Social Functioning (n= 57)EOT: Role-Emotional (n= 57)EOT: Mental Health (n= 57)EOT: Physical (PCS) (n= 57)EOT: Mental (MCS) (n= 57)
Dalteparin34.736.545.144.148.134.336.642.140.141.434.835.145.542.948.735.136.342.239.441.9

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Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism

(NCT00786474)
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)

,
Interventionparticipants (Number)
DeathMyocardial infarctionDeep-vein thrombosispulmonary embolism
Dalteparin41411
Placebo5700

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Number of Arterial Thromboembolic Events

The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated (NCT00786474)
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)

,
InterventionArterial thromboembolic events (Number)
StrokeTransient Ischemic AttackSystemic embolism
Dalteparin300
Placebo220

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Major Bleeding

Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death (NCT00786474)
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)

Interventionparticipants (Number)
Placebo12
Dalteparin29

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Number of Participants With Minor Bleeding

Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding (NCT00786474)
Timeframe: from subject signing of the consent until completed the study (Day -30 to Day +37)

Interventionparticipants (Number)
Placebo110
Dalteparin187

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Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]

Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components (NCT00790842)
Timeframe: 56 months

Interventionpercentage of participants (Number)
Group A CrCl 30-60 mL/Min60.0
Group B CrCL<30 mL/Min, Not on Dialysis60.0
Group C CrCL<30 mL/Min and on Dialysis20.0

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Progression-free Survival

Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment. (NCT00790842)
Timeframe: 56 months

InterventionMonths (Median)
Group A=30-60 CrCl (mL/Min)12.6
Group B=CrCL<30 mL/Min Not on Dialysis11.4
Group C=CrCL<30 mL/Min and on DialysisNA

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Duration of Response

Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression. (NCT00790842)
Timeframe: 56 months

InterventionMonths (Median)
Group A=30-60 CrCl (mL/Min)21.8
Group B=CrCL<30 mL/Min Not on Dialysis8.4
Group C=CrCL<30 mL/Min and on Dialysis25.4

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Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy

"Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:~Grade 3 or higher neutropenia with fever ≥38.5 degrees C~Grade 4 neutropenia ≥7 days~Grade 4 or higher thrombocytopenia~Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause" (NCT00790842)
Timeframe: First cycle of therapy (28 days)

InterventionParticipants (Count of Participants)
Group A Lenalidomide 10 mg/Day0
Group A Lenalidomide 15 mg/Day0
Group A Lenalidomide 25 mg/Day0
Group B Lenalidomide 15 mg/2 Days0
Group B Lenalidomide 25 mg/2 Days0
Group B Lenalidomide 15 mg/Day0
Group B Lenalidomide 25 mg/Day0
Group C Lenalidomide 15 mg 3x/Week0
Group C Lenalidomide 10 mg/Day0
Group C Lenalidomide 15 mg/Day0
Group C Lenalidomide 25 mg/Day0

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Overall Survival Time

Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive. (NCT00790842)
Timeframe: 56 months

Interventionmonths (Median)
Group A=30-60 CrCl (mL/Min)20.8
Group B=CrCL<30 mL/Min Not on Dialysis20.0
Group C=CrCL<30 mL/Min and on DialysisNA

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Percentage of Patients Who Experienced Clinically Significant Bleeding Events.

The percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma > 25 cm², epistaxis > 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding > 5 mins, hemoptysis, hematemesis or prolonged bleeding (> 5 minutes) after venipuncture. (NCT00876915)
Timeframe: 13 weeks

Interventionpercentage of participants (Number)
Dalteparin Injection14
No Therapy2

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Percentage of Patients With Venous Thromboembolisms

The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT. (NCT00876915)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Dalteparin Injection12
No Therapy21

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The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients

Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients (NCT00876915)
Timeframe: baseline value of D-Dimer

Interventionug/mL (Mean)
High Risk2.99
Low Risk1.87

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The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients

Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients (NCT00876915)
Timeframe: baseline value of FVIIa

InterventionpM (Mean)
High Risk151.2
Low Risk148.6

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The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients

Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients (NCT00876915)
Timeframe: baseline value of Human F12

Interventionng/mL (Mean)
High Risk484.7
Low Risk306.3

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The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients

Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients (NCT00876915)
Timeframe: baseline value of TAT

Interventionug/L (Mean)
High Risk9.89
Low Risk12.44

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The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients

Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients (NCT00876915)
Timeframe: baseline value of TFPI

Interventionpg/mL (Mean)
High Risk813.6
Low Risk738.2

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The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients

Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients. (NCT00876915)
Timeframe: baseline value of tissue factor

Interventionpg/mL (Mean)
High Risk0.669
Low Risk0.187

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Number of Participants With Cardiac Arrest- Resuscitated

Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing. (NCT00922766)
Timeframe: Baseline to 28 days after last dose of study drug

InterventionParticipants (Number)
Dalteparin2

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Number of Participants With Death or Myocardial Infarction (MI)

(NCT00922766)
Timeframe: Baseline to 28 days after last dose of study drug

InterventionParticipants (Number)
Dalteparin3

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Number of Participants With Heparin Induced Thrombocytopenia

Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood. (NCT00922766)
Timeframe: Baseline to 28 days after last dose of study drug

InterventionParticipants (Number)
Dalteparin0

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Number of Participants With Major Bleeding Events

Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding. (NCT00922766)
Timeframe: Baseline to 28 days after last dose of study drug

InterventionParticipants (Number)
Dalteparin0

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Number of Participants With Minor Bleeding Events

Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding. (NCT00922766)
Timeframe: Baseline to 28 days after last dose of study drug

InterventionParticipants (Number)
Dalteparin1

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Number of Participants With Stroke

Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma). (NCT00922766)
Timeframe: Baseline to 28 days after last dose of study drug

InterventionParticipants (Number)
Dalteparin0

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Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee

VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported. (NCT00942968)
Timeframe: Month 7 up to Month 12

Interventionparticipants (Number)
Dalteparin Sodium8

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Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings

Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms. (NCT00942968)
Timeframe: Baseline up to Week 52

Interventionparticipants (Number)
Dalteparin Sodium8

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Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee

Time to first occurrence of any bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first bleeding event (major or minor). A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. (NCT00942968)
Timeframe: Month 1 up to Month 12

Interventiondays (Mean)
Dalteparin Sodium262.5

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Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee

Time to first occurrence of major bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. (NCT00942968)
Timeframe: Month 1 up to Month 12

Interventiondays (Mean)
Dalteparin Sodium332.9

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Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee

Time to first occurrence of new or recurrent VTE was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. (NCT00942968)
Timeframe: Month 1 up to Month 12

Interventiondays (Mean)
Dalteparin Sodium294.1

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Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee

Time to first occurrence of new or recurrent VTE or CVT was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE or CVT. VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE) .DVT is a blood clot in the deep veins of the leg. If a DVT clot that breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan, contrast venography or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. (NCT00942968)
Timeframe: Month 1 up to Month 12

Interventiondays (Mean)
Dalteparin Sodium294.1

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Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants

Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. (NCT00942968)
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

InterventionmL/min (Mean)
Baseline (n=17)Week 4 (n=15)Week 8 (n=13)Week 12 (n=13)Week 16 (n=4)Week 20 (n=2)Week 24 (n=12)Week 28 (n=1)Week 32 (n=1)Week 36 (n=8)Week 40 (n=2)Week 44 (n=2)Week 48 (n=6)Week 52 (n=11)
Dalteparin Sodium46.0-8.62.52.1-9.27.74.5-44.0-14.05.8-21.0-20.0-26.04.8

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Number of Participants With Abnormal Physical Examinations Findings

Physical examinations included head, ears, nose, throat (ENT), neck, heart, chest, lungs, abdomen, extremities, neurological systems, skin, general appearance and others (thigh, abdomen unobtrusive scar, breast, cardio-vascular, constitutional, face, genitalia, genitourinary, gastrointestinal, hematologic, left ankle unobtrusive scar, lymph nodes, lymphatic, malaise/fatigue, mouth, musculoskeletal, musculoskeletal, peripherally inserted central catheters line site left arm, psychiatric, skeletal, urinary, weight, activity level, bladder irritation, dyspnea and eastern cooperative oncology group performance status [used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead]). Abnormality in physical examinations was based on investigator's discretion. (NCT00942968)
Timeframe: Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52

Interventionparticipants (Number)
Baseline : Head (n=327)Baseline : Ears, nose, throat (ENT)(n=327)Baseline : Neck (n=327)Baseline : Heart (n=327)Baseline : Chest (n=326)Baseline : Lungs (n=327)Baseline : Abdomen (n=327)Baseline : Extremities (n=328)Baseline : Neurological systems (n=327)Baseline : Skin (n=327)Baseline : General appearance (n=327)Baseline : Others (n=47)Week 1 : Head (n=213)Week 1 : ENT (n=214)Week 1 : Neck (n=214)Week 1 : Heart (n=214)Week 1 : Chest (n=213)Week 1 : Lungs (n=214)Week 1 :Abdomen (n=214)Week 1 : Extremities (n=213)Week 1 : Neurological systems (n=213)Week 1 : Skin (n=213)Week 1 : General appearance (n=212)Week 1:Others (n=41)Week 4 : Head (n=211)Week 4 : ENT (n=211)Week 4 : Neck (n=211)Week 4 : Heart (n=210)Week 4 : Chest (n=211)Week 4 : Lungs (n=211)Week 4 : Abdomen (n=210)Week 4 : Extremities (n=211)Week 4 : Neurological systems (n=211)Week 4 : Skin (n=210)Week 4 : General appearance (n=208)Week 4 : Others (n=23)Week 8 : Head (n=186)Week 8 : ENT (n=186)Week 8 : Neck (n=185)Week 8 : Heart (n=186)Week 8 : Chest (n=186)Week 8 : Lungs (n=186)Week 8 : Abdomen (n=186)Week 8 : Extremities (n=186)Week 8 : Neurological systems (n=185)Week 8 : Skin (n=186)Week 8 : General appearance (n=186)Week 8 : Others (n=16)Week 12 : Head (n=183)Week 12 : ENT (n=183)Week 12 : Neck (n=183)Week 12 : Heart (n=183)Week 12 : Chest (n=183)Week 12 : Lungs (n=183)Week 12 : Abdomen (n=183)Week 12 : Extremities (n=183)Week 12 : Neurological systems (n=183)Week 12 : Skin (n=183)Week 12 : General appearance (n=182)Week 12 : Other (n=27)Week 24 : Head (n=166)Week 24 : ENT (n=166)Week 24 : Neck (n=166)Week 24 : Heart (n=166)Week 24 : Chest (n=166)Week 24 : Lungs (n=166)Week 24 : Abdomen (n=166)Week 24 : Extremities (n=166)Week 24 : Neurological systems (n=166)Week 24 : Skin (n=166)Week 24 : General appearance (n=166)Week 24 : Others (n=17)Week 36 : Head (n=127)Week 36 : ENT (n=127)Week 36 : Neck (n=127)Week 36 : Heart (n=127)Week 36 : Chest (n=127)Week 36 : Lungs (n=127)Week 36 : Abdomen (n=126)Week 36 : Extremities (n=127)Week 36 : Neurological systems (n=127)Week 36 : Skin (n=127)Week 36 : General appearance (n=126)Week 36 : Others (n=14)Week 48 : Head (n=103)Week 48 : ENT (n=103)Week 48 : Neck (n=103)Week 48 : Heart (n=103)Week 48 : Chest (n=103)Week 48 : Lungs (n=102)Week 48 : Abdomen (n=103)Week 48 : Extremities (n=103)Week 48 : Neurological systems (n=103)Week 48 : Skin (n=103)Week 48 : General appearance (n=103)Week 48 : Others (n=7)Week 52 : Head (n=193)Week 52 : ENT (n=193)Week 52 : Neck (n=193)Week 52 : Heart (n=193)Week 52 : Chest (n=193)Week 52 : Lungs (n=191)Week 52 : Abdomen (n=193)Week 52 : Extremities (n=193)Week 52 : Neurological systems (n=193)Week 52 : Skin (n=193)Week 52 : General appearance (n=193)Week 52 : Others (n=25)
Dalteparin Sodium14201026406573203185147251620710222862103165225231216682324598394925201116482131498013381612101219221547571939181621249171437471435911694718123537932119263711142729829937135122323606824382715

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Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee

A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. In this outcome measure, number of participants with any (major or minor) bleeding events (adjudicated by Central Adjudication Committee) were reported. (NCT00942968)
Timeframe: Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12

Interventionparticipants (Number)
Month 1 up to Month 6Month 7 up to Month 12Month 1 up to Month 12Month 2 up to Month 6Month 2 up to Month 12
Dalteparin Sodium91211124768

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Number of Participants With Fatal Bleeding Events

Fatal bleeding events refers to those bleeding events which leads to death of participant. In this outcome measure, number of participants with fatal bleeding events were reported. (NCT00942968)
Timeframe: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

Interventionparticipants (Number)
Month 1 up to Month 6Month 7 up to Month 12Month 1 up to Month 12Month 2 up to Month 6Month 2 up to Month 12
Dalteparin Sodium11212

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Number of Participants With Investigator Identified Major Bleeding Events

A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (identified by investigator) were reported. (NCT00942968)
Timeframe: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

Interventionparticipants (Number)
Month 1 up to Month 6Month 7 up to Month 12Month 1 up to Month 12Month 2 up to Month 6Month 2 up to Month 12
Dalteparin Sodium287351522

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Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)

VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (identified by investigator) were reported. (NCT00942968)
Timeframe: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

Interventionparticipants (Number)
Month 1 up to Month 6 (n=334)Month 7 up to Month 12 (n=195)Month 1 up to Month 12 (n=334)Month 2 up to Month 6 (n=295)Month 2 up to Month 12 (n=295)
Dalteparin Sodium29837917

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Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)

VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (identified by investigator) were reported. (NCT00942968)
Timeframe: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

Interventionparticipants (Number)
Month 1 up to Month 6 (n=334)Month 7 up to Month 12 (n=195)Month 1 up to Month 12 (n=334)Month 2 up to Month 6 (n=295)Month 2 up to Month 12 (n=295)
Dalteparin Sodium29837917

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. (NCT00942968)
Timeframe: Baseline (Day 1) up to Week 52

Interventionparticipants (Number)
AESAE
Dalteparin Sodium328213

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Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee

A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported. (NCT00942968)
Timeframe: Month 2 up to Month 6

Interventionparticipants (Number)
Dalteparin Sodium14

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Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee

VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (adjudicated by Central Adjudication Committee) were reported. (NCT00942968)
Timeframe: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12

Interventionparticipants (Number)
Month 1 up to Month 6 (n=334)Month 7 up to Month 12 (n=194)Month 1 up to Month 12 (n=334)Month 2 up to Month 6 (n=296)Month 2 up to Month 12 (n=296)
Dalteparin Sodium298371018

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Number of Participants With Clinically Significant Laboratory Abnormalities

Criteria for abnormality: Hemoglobin greater than or equal to(>=)130*lower limit of normal(LLN); less than or equal to(<=)170*upper limit of normal(ULN), hematocrit >=0.39*LLN;<=0.51*ULN, red blood cell >=4.5*LLN;<=5.9*ULN, platelet>=150*LLN;<= 450*ULN, white blood cells >=4*LLN;<=11*ULN; lymphocytes>=0.09;<=0.44, neutrophils=>0.16*LLN;<=0.7*ULN, eosinophils<=0.04*ULN, basophils<=0.02*ULN, monocytes>0.08*ULN; bilirubin >=5.1*LLN;<=22.2*ULN, aspartate aminotransferase >=13*LLN;<=36*ULN, alanine aminotransferase>=11*LLN;<=54*ULN, alkaline phosphatase>=31*LLN ;<=104 *ULN, total protein>=60*LLN; <=76*ULN, albumin=>35*LLN;<=50*ULN, glucose>=3.77 ;<=6.05;blood urea nitrogen>=1.785*LLN;<=7.5*ULN, creatinine>=70.7*LLN;<=114.9*ULN, creatinine kinase>=30*LLN ;<=280*ULN, lactate dehydrogenase>=85*LLN;<=180*ULN, sodium>=137*LLN ;<=144*ULN, potassium >=3.5*LLN;<=5*ULN, chloride>=102*LLN;<=111*ULN, calcium>=2.22*LLN ;<=2.57*ULN, phosphorus=>0.81 ;<=1.45); nitrogen cholesterol>=1.78*LLN ;<=7.49*ULN. (NCT00942968)
Timeframe: Baseline (Day 1) up to Week 52

Interventionparticipants (Number)
Dalteparin Sodium0

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Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee

A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported. (NCT00942968)
Timeframe: Month 7 up to Month 12

Interventionparticipants (Number)
Dalteparin Sodium8

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Absolute Values of Body Temperature of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,,,,
Interventiondegree celsius (Median)
BaselineDay 1Day 2Day 30Day 60Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)36.6036.7036.9036.5036.6036.70
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)36.7036.8536.4036.5036.7037.15
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)36.5036.8036.7036.6036.8036.75
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)37.0036.7036.7036.5036.6036.90
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)36.8036.8036.7036.7036.6036.80

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Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,
Interventionbeats per minute (bpm) (Median)
HR: BaselineHR: Day 1HR: Day 2HR: Day 30HR: Day 60HR: Day 90PR: BaselinePR: Day 1PR: Day 2PR: Day 30PR: Day 60PR: Day 90
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)115.00112.00114.00120.50120.00107.0096.50121.00117.0088.0088.00114.00
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)70.0085.0075.0087.5094.5080.0073.0094.5093.00102.0095.0092.00

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Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Interventionbeats per minute (bpm) (Median)
HR: BaselineHR: Day 1HR: Day 2HR: Day 30HR: Day 60HR: Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)148.00146.00136.00138.00132.00122.00

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Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Interventionbeats per minute (bpm) (Median)
PR: BaselinePR: Day 1PR: Day 2PR: Day 30PR: Day 60PR: Day 90
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)114.0087.0098.00101.0093.0096.00

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Absolute Values of Body Length of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,,
Interventioncentimeter (Median)
BaselineDay 1Day 2Day 30Day 60Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)545456606364
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)555555.3056.606061
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)172135135135135151.75

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Absolute Values of Body Length of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Interventioncentimeter (Median)
BaselineDay 2Day 30Day 60Day 90
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)100104.7510010397.75

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Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)

It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Interventiondays (Median)
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)NA

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Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

InterventionParticipants (Count of Participants)
Abdomen: ScreeningAbdomen: Visit 3Abdomen: Visit 4Abdomen: Visit 5Abdomen: Visit 6Abdomen: Visit 7Chest: ScreeningChest: Visit 3Chest: Visit 4Chest: Visit 5Chest: Visit 6Chest: Visit 7Extremities: ScreeningExtremities: Visit 3Extremities: Visit 4Extremities: Visit 5Extremities: Visit 6Extremities: Visit 7Eyes, ears, nose, throat:ScreeningEyes, ears, nose, throat: Visit 3Eyes, ears, nose, throat: Visit 4Eyes, ears, nose, throat: Visit 5Eyes, ears, nose, throat: Visit 6Eyes, ears, nose, throat: Visit 7General appearance: ScreeningGeneral appearance: Visit 3General appearance: Visit 4General appearance: Visit 5General appearance: Visit 6General appearance: Visit 7Head: ScreeningHead: Visit 3Head: Visit 4Head: Visit 5Head: Visit 6Head: Visit 7Heart: ScreeningHeart: Visit 3Heart: Visit 4Heart: Visit 7Lungs: ScreeningLungs: Visit 4Lungs: Visit 6Lungs: Visit 7Neck: ScreeningNeck: Visit 4Neurological: ScreeningNeurological: Visit 3Neurological: Visit 4Neurological: Visit 5Neurological: Visit 7Skin: ScreeningSkin: Visit 3Skin: Visit 4Skin: Visit 5Skin: Visit 6Skin: Visit 7
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)001111223112434112000000101002100111100010001000000312223

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Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Interventionbeats per minute (bpm) (Median)
HR: BaselineHR: Day 1HR: Day 2HR: Day 30HR: Day 60HR: Day 90PR: Day 1PR: Day 90
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)146.00142.00130.00130.00184.00134.00108.00140.00

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Absolute Values of Height of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Interventioncentimeters (cm) (Median)
BaselineDay 30Day 60Day 90
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)55.0056.6060.0061.00

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Absolute Values of Height of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Interventioncentimeters (cm) (Median)
BaselineDay 1Day 30Day 60Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)54.0054.0060.0063.0064.00

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Absolute Values of Height of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,,
Interventioncentimeters (cm) (Median)
BaselineDay 1Day 2Day 30Day 60Day 90
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)110.00115.80107.90115.10115.00109.50
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)133.00134.00142.00140.30139.70140.70
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)166.00166.00166.90167.75168.50166.65

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Absolute Values of Respiratory Rate of Participants

Respiratory rate was defined as the number of breaths per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,,,,
Interventionbreaths per minute (Median)
BaselineDay 1Day 2Day 30Day 60Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)35.0034.0034.0034.0030.0024.00
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)25.0036.0034.0036.0036.0034.00
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)24.0021.0020.0022.0020.0022.00
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)20.0018.0020.0022.0020.0020.00
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)20.0018.0018.0018.0020.0018.00

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Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,,,,
Interventionmillimeters of mercury (mmHg) (Median)
SBP: BaselineSBP: Day 1SBP: Day 2SBP: Day 30SBP: Day 60SBP: Day 90DSBP: BaselineDSBP: Day 1DSBP: Day 2DSBP: Day 30DSBP: Day 60DSBP: Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)101.0097.0094.0077.074.0076.0060.0061.0048.0053.0051.0053.00
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)50.00105.5075.0077.00102.00105.0041.0057.0053.0061.0057.0055.50
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)110.50112.0107.00112.00101.0097.5066.0065.5060.5064.0060.0060.50
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)96.00111.00112.00109.00118.00116.0067.0066.5070.0068.0067.0067.00
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)117.50113.00119.50118.00117.50116.0065.0064.0065.0069.0067.0069.00

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Absolute Values of Weight of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

,,,,
Interventionkilograms (Median)
BaselineDay 1Day 2Day 30Day 60Day 90
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)4.054.174.506.307.157.70
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)3.934.044.154.564.604.70
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)18.7817.2314.9515.5016.6021.50
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)36.6037.0039.3539.2038.3039.30
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)60.0063.4058.0063.8065.8059.60

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Time to First Occurrence of Major Bleeding Event

Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal). (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Interventiondays (Median)
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)NA

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Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

InterventionParticipants (Count of Participants)
Abdomen: ScreeningAbdomen: Visit 2Abdomen: Visit 3Abdomen: Visit 4Abdomen: Visit 5Abdomen: Visit 6Abdomen: Visit 7Chest: ScreeningChest: Visit 2Chest: Visit 3Chest: Visit 4Chest: Visit 5Chest: Visit 6Chest: Visit 7Extremities: ScreeningExtremities: Visit 2Extremities: Visit 3Extremities: Visit 4Extremities: Visit 5Extremities: Visit 6Extremities: Visit 7Eyes: ScreeningEyes: Visit 2Eyes: Visit 3Eyes: Visit 4Eyes: Visit 5Eyes: Visit 6Eyes: Visit 7Eyes, ears, nose, throat:ScreeningGeneral appearance: ScreeningGeneral appearance: Visit 2General appearance: Visit 3General appearance: Visit 4General appearance: Visit 5General appearance: Visit 6General appearance: Visit 7Head: ScreeningHead: Visit 3Head: Visit 4Head: Visit 5Head: Visit 6Head: Visit 7Heart: ScreeningHeart: Visit 3Heart: Visit 4Heart: Visit 7Lungs: ScreeningLungs: Visit 4Lungs: Visit 6Lungs: Visit 7Neck: ScreeningNeck: Visit 4Neurological: ScreeningNeurological: Visit 2Neurological: Visit 3Neurological: Visit 4Neurological: Visit 5Neurological: Visit 7Nose: ScreeningNose: Visit 2Skin: ScreeningSkin: Visit 2Skin: Visit 3Skin: Visit 4Skin: Visit 5Skin: Visit 6Skin: Visit 7
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)0000000000000000000000000000000000000000000000000000000000001110000

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Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

InterventionParticipants (Count of Participants)
Abdomen: ScreeningAbdomen: Visit 2Abdomen: Visit 3Abdomen: Visit 4Abdomen: Visit 5Abdomen: Visit 6Abdomen: Visit 7Chest: ScreeningChest: Visit 2Chest: Visit 3Chest: Visit 4Chest: Visit 5Chest: Visit 6Chest: Visit 7Extremities: ScreeningExtremities: Visit 2Extremities: Visit 3Extremities: Visit 4Extremities: Visit 5Extremities: Visit 6Extremities: Visit 7Eyes: ScreeningEyes: Visit 2Eyes: Visit 3Eyes: Visit 4Eyes: Visit 5Eyes: Visit 6Eyes: Visit 7Eyes, ears, nose, throat:ScreeningEyes, ears, nose, throat: Visit 3Eyes, ears, nose, throat: Visit 4Eyes, ears, nose, throat: Visit 7General appearance: ScreeningGeneral appearance: Visit 2General appearance: Visit 3General appearance: Visit 4General appearance: Visit 5General appearance: Visit 6General appearance: Visit 7Head: ScreeningHead: Visit 3Head: Visit 4Head: Visit 5Head: Visit 6Head: Visit 7Heart: ScreeningHeart: Visit 3Heart: Visit 4Heart: Visit 7Lungs: ScreeningLungs: Visit 4Lungs: Visit 6Lungs: Visit 7Neck: ScreeningNeck: Visit 4Neurological: ScreeningNeurological: Visit 2Neurological: Visit 3Neurological: Visit 4Neurological: Visit 5Neurological: Visit 7Nose: ScreeningNose: Visit 2Skin: ScreeningSkin: Visit 2Skin: Visit 3Skin: Visit 4Skin: Visit 5Skin: Visit 6Skin: Visit 7
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)1010001000000000000000000000100000000100000000111000010000001001011001

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Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

,
InterventionParticipants (Count of Participants)
Abdomen: ScreeningAbdomen: Visit 2Abdomen: Visit 3Abdomen: Visit 4Abdomen: Visit 5Abdomen: Visit 6Abdomen: Visit 7Chest: ScreeningChest: Visit 2Chest: Visit 3Chest: Visit 4Chest: Visit 5Chest: Visit 6Chest: Visit 7Extremities: ScreeningExtremities: Visit 2Extremities: Visit 3Extremities: Visit 4Extremities: Visit 5Extremities: Visit 6Extremities: Visit 7Eyes: ScreeningEyes: Visit 2Eyes: Visit 3Eyes: Visit 4Eyes: Visit 5Eyes: Visit 6Eyes: Visit 7Eyes, ears, nose, throat:ScreeningEyes, ears, nose, throat: Visit 3Eyes, ears, nose, throat: Visit 4Eyes, ears, nose, throat: Visit 5Eyes, ears, nose, throat: Visit 6Eyes, ears, nose, throat: Visit 7General appearance: ScreeningGeneral appearance: Visit 2General appearance: Visit 3General appearance: Visit 4General appearance: Visit 5General appearance: Visit 6General appearance: Visit 7Head: ScreeningHead: Visit 3Head: Visit 4Head: Visit 5Head: Visit 6Head: Visit 7Heart: ScreeningHeart: Visit 3Heart: Visit 4Heart: Visit 7Lungs: ScreeningLungs: Visit 4Lungs: Visit 6Lungs: Visit 7Neck: ScreeningNeck: Visit 4Neurological: ScreeningNeurological: Visit 2Neurological: Visit 3Neurological: Visit 4Neurological: Visit 5Neurological: Visit 7Nose: ScreeningNose: Visit 2Skin: ScreeningSkin: Visit 2Skin: Visit 3Skin: Visit 4Skin: Visit 5Skin: Visit 6Skin: Visit 7
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)221100012000000110000100000011002121100011111111010000010211000111012201
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)2023413200100310138322111211121231230122124254350012011121000110005136754

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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

,,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)10
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)22
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)73
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)73
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)1913

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Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure. (NCT00952380)
Timeframe: Day 30, Day 60, Day 90 in follow up phase

,,,
Interventionpercentage of participants (Number)
Day 30Day 60Day 90
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)100.0100.0100.0
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)100.0100.0100.0
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)33.375.050.0
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)93.381.872.7

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Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase

Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure. (NCT00952380)
Timeframe: Day 30, Day 60, Day 90 in follow-up phase

,,,
Interventionpercentage of participants (Number)
Day 30Day 60Day 90
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)000
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)000
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)66.725.050.0
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)6.718.227.3

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Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)

VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

,,,
Interventionpercentage of participants (Number)
ProgressionRegressionResolutionNo Change
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)00100.00
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)012.562.50
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)014.357.114.3
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)029.458.85.9

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Percentage of Participants With Major and Minor Bleeding Event

A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding). (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

,,,,
Interventionpercentage of participants (Number)
Major BleedingMinor Bleeding
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)00
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)50.00
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)050.0
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)057.1
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)040.0

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Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure. (NCT00952380)
Timeframe: Day 1 to 7 in dose adjustment phase

Interventionpercentage of participants (Number)
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)0
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)100.0
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)100.0
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)100.0
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)85.0

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Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)

Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

InterventionParticipants (Count of Participants)
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)0
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)0
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)1
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)0

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Number of Participants With Laboratory Abnormalities

Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1* ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, >1.0* ULN. Urinalysis: creatinine >1.0*ULN. (NCT00952380)
Timeframe: Baseline up to 104 days

InterventionParticipants (Count of Participants)
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)1
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)2
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)8
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)5
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)19

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Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels

During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported. (NCT00952380)
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Interventiondose adjustment (Median)
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)3.5
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)0.5
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)0.0
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)0.0

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Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported. (NCT00952380)
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase

InterventionIU/mL (Median)
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)125

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Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported. (NCT00952380)
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase

InterventionIU/kg (Mean)
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)207.50
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)141.85
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)132.40
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)115.06

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Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels

Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported. (NCT00952380)
Timeframe: Day 1 to 7 in dose adjustment phase

Interventiondays (Median)
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)4.5
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)3.0
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)2.0
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)2.0

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Number of Participants With Venous Thromboembolic Events (VTE)

Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE. (NCT00966277)
Timeframe: 16 weeks of treatment

Interventionparticipants (Number)
Group 1: Dalteparin2
Group 2: Control9

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The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality

(NCT00986154)
Timeframe: 12 months from time of randomization

Interventionnumber of participants with event (Number)
Heparin/Edoxaban Tosylate228
Heparin/Warfarin228

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Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE

"Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.~Overall Study Period defined as The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit." (NCT00986154)
Timeframe: 12 months from time of randomization

Interventionnumber or participants with an event (Number)
Heparin/Edoxaban Tosylate130
Heparin/Warfarin146

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Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment

Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period. (NCT00986154)
Timeframe: 12 months from time of randomization

Interventionparticipants with an event (Number)
Heparin/Edoxaban Tosylate349
Heparin/Warfarin423

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Physician's Assessment of Efficacy of Treatment

Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
ExcellentVery goodGoodFairPoorNot reported
Dalteparin Sodium4324422122

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Participant's Global Evaluation of Treatment

Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
Overall response (Excellent)Overall response (Good)Overall response (Fair)Overall response (Poor)Overall comfort (Excellent)Overall comfort (Good)Overall comfort (Fair)Overall comfort (Poor)
Dalteparin Sodium2362202011292381064

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Participant's Dosage Regimen

Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
Dosage Regimen 1Dosage Regimen 2Dosage Regimen 3Other
Dalteparin Sodium327211559

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Number of Participants With Risk Factors

Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA. (NCT01046903)
Timeframe: Baseline

InterventionParticipants (Number)
AgeObesityGenderPregnancyLiver diseaseKidney diseaseHormone therapyImmobilizationPrevious surgeryConcomitant malignant diseasePositive family historyVaricose veinsSmokingChemotherapyCatheter in veinHeart failure III New York Heart Association(NYHA)Heart failure IV NYHA
Dalteparin Sodium35320529112872051257111618192420460

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Number of Participants With Bleeding

Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor bleeding was defined as bleeding that did not meet the definition of major bleeding. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
Major BleedingMinor Bleeding
Dalteparin Sodium00

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Administration Schedule of Treatment

Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
Administration Schedule 1Administration Schedule 2Administration Schedule 3Other
Dalteparin Sodium327211559

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Number of Participants With Thromboembolism

Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin). (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
Dalteparin Sodium3

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Number of Participants With Hematoma

Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
Dalteparin Sodium2

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Physician's Assessment of Tolerability of Treatment

Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor. (NCT01046903)
Timeframe: Baseline up to Week 5

InterventionParticipants (Number)
ExcellentVery goodGoodFairPoorNot reported
Dalteparin Sodium354116100023

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Conventional Coagulation Testing Parameters

Plasma based conventional coagulation testing parameters - Fibrinogen (NCT01050153)
Timeframe: Study day five.

Interventionmg/dL (Mean)
Control (Standard of Care)691.4
TEG-guided Thromboprophylaxis687.11

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Conventional Coagulation Testing Parameters

Plasma based conventional coagulation testing parameters - Protein C (NCT01050153)
Timeframe: Study day five.

Interventionpercentage of activity (Mean)
Control (Standard of Care)76.65
TEG-guided Thromboprophylaxis79.83

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Hypercoagulability

To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9. (NCT01050153)
Timeframe: Study day five.

Interventionparticipants (Number)
Control (Standard of Care)16
TEG-guided Thromboprophylaxis18

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Incidence of VTE

The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only) (NCT01050153)
Timeframe: Day 28 or discharge, whichever comes first.

Interventionparticipants (Number)
Control (Standard of Care)0
TEG-guided Thromboprophylaxis0

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International Normalized Ratio (INR)

Plasma based conventional coagulation testing parameters (NCT01050153)
Timeframe: Study day five.

Interventionratio (Mean)
Control (Standard of Care)1.23
TEG-guided Thromboprophylaxis1.13

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Platelet Count

Platelet count measured by CBC test (NCT01050153)
Timeframe: Study day five.

Intervention* 10^3 platelets/µL (Mean)
Control (Standard of Care)261.64
TEG-guided Thromboprophylaxis267.76

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TEG Parameters

"Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).~The absolute SEMS of the sample can be calculated from MA as follows:~G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA." (NCT01050153)
Timeframe: Study day five.

InterventionKd/sc (Mean)
Control (Standard of Care)14.97
TEG-guided Thromboprophylaxis15.46

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TEG Parameters

"R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).~Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.~Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).~Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.~MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets." (NCT01050153)
Timeframe: Study day five.

,
InterventionMinutes (Mean)
R valueRf value
Control (Standard of Care)5.89-0.09
TEG-guided Thromboprophylaxis5.83-0.34

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Conventional Coagulation Testing Parameters

Plasma based conventional coagulation testing parameters - Anti Xa (NCT01050153)
Timeframe: Study day five.

InterventionIU/mL (Mean)
Control (Standard of Care)0.14
TEG-guided Thromboprophylaxis0.18

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Conventional Coagulation Testing Parameters

Plasma based conventional coagulation testing parameters - Anti-thrombin III (NCT01050153)
Timeframe: Study day five.

Interventionpercentage of activity (Mean)
Control (Standard of Care)79.3
TEG-guided Thromboprophylaxis80

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Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)

Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands. (NCT01064362)
Timeframe: Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.

,
Interventionparticipants (Number)
Bleeding or hematoma as complication of a surgeryEpistaxis
Fondaparinux10
Low Molecular Weight Heparins (LMWHs)01

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Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)

Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands. (NCT01064362)
Timeframe: Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first

,
Interventionparticipants (Number)
Bleeding or hematoma as complication of a surgeryEpistaxisGastrointestinal bleedsHemarthrosisIntracranial bleedsUrinary tract bleeding
Fondaparinux700001
Low Molecular Weight Heparins (LMWHs)1039211

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Death From Venous Thromboembolism

"If a subject dies between randomization and late postpartum follow up (Day 90 +/- 7 days) the death will be adjudicated as certain, highly probable, probable, or unlikely due to Pulmonary Embolism (PE) using the following criteria.~Certain: hypotension, hypoxia, cardiac arrest with no other explanation other than PE and autopsy or radiographic confirmation Highly probable: criteria for certain but another disease could have caused the death Probable: other cause suspected based on clinical evidence but 100% certainty not available Unlikely: all other cases." (NCT01274637)
Timeframe: From Randomization to Day 90

InterventionParticipants (Count of Participants)
Low Molecular Weight Heparin0
Control Group0

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Feasibility of Recruitment and Trial Operations.

The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site. (NCT01274637)
Timeframe: 4 months

Interventionparticipants per site per month (Number)
Low Molecular Weight Heparin0.9
Control Group0.9

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Heparin Induced Thrombocytopenia

All subjects who develop thrombocytopenia (platelets less than 80 x 109/L and/or with >50% decrease from baseline) will be investigated for Heparin Induced Thrombocytopenia (HIT) by having ELISA and serotonin release assays to confirm or refute a diagnosis of HIT. HIT will be diagnosed with a positive PF4 (platelet factor 4) HIT ELISA assay. (NCT01274637)
Timeframe: From Randomization to Day 90

InterventionParticipants (Count of Participants)
Low Molecular Weight Heparin0
Control Group0

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Late Symptomatic Venous Thromboembolism

This includes symptomatic Deep Vein Thrombosis or Pulmonary Embolism. Suspected outcomes will be adjudicated by a blinded adjudication committee. (NCT01274637)
Timeframe: From Day 10 to Day 90

InterventionParticipants (Count of Participants)
Low Molecular Weight Heparin0
Control Group0

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Major Bleeding or Clinically Relevant Non-major Bleeding

"Major bleeding meets at least one of the following: Fatal bleeding; Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, retroperitoneal, etc.); Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells .~Clinically Relevant Non-major Bleeding does not meet the criteria for major bleeding but meets at least one of the following: Hospitalization; Medical intervention; Unscheduled contact with a physician; Discomfort (pain, or impairment of activities of daily life)." (NCT01274637)
Timeframe: From Randomization to Day 90

InterventionParticipants (Count of Participants)
Low Molecular Weight Heparin3
Control Group1

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Venous Thromboembolism in the Early Postpartum Period.

This includes symptomatic Deep Vein Thrombosis (DVT) or pulmonary embolism (PE) in the interval between randomization and the last dose of study drug (10 days +/- 3 days) OR asymptomatic proximal DVT detected by compression ultrasound of both legs done within 24hrs of the last dose of study drug (10 days (+/- 3 days) postpartum). Compressed and non-compressed images will be obtained from the calf trifurcation to the inguinal ligament. All suspected outcomes will be adjudicated by a blinded expert adjudication committee. (NCT01274637)
Timeframe: From randomization to Day 10

InterventionParticipants (Count of Participants)
Low Molecular Weight Heparin0
Control Group0

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Change in Clinical Pain Scores

"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other." (NCT01419977)
Timeframe: Baseline to day 1

Interventionunits on a scale (Mean)
Placebo-0.3
Dalteparin-1.6

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Change in Clinical Pain Scores

"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other." (NCT01419977)
Timeframe: Baseline to day 3

Interventionunits on a scale (Mean)
Placebo-0.9
Dalteparin-2.4

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Change in D-dimer

Patients will have D-dimer,for samples drawn on Day 1 and Day 3 (NCT01419977)
Timeframe: Day 1 and Day 3

Interventionng/mL (Mean)
Placebo478.8
Dalteparin260.1

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Change in Thrombin Generation Assay - Endogenous Thrombin Potential

Patients will have thrombin generation assay samples drawn on Day 1 and 3 (NCT01419977)
Timeframe: Day 1 and Day 3

InterventionnM (Mean)
Placebo13.4
Dalteparin-45.98

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Mean Percent of Successful HD Sessions

A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data. (NCT01879618)
Timeframe: 20 HD sessions (up to 4 hours)

InterventionPercentage of HD Sessions (Mean)
FRAGMIN99.9

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Mean Percent of HD Sessions With an Acceptable Dose

A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial. (NCT01879618)
Timeframe: 20 HD sessions (up to 4 hours)

InterventionPercentage of HD sessions (Mean)
FRAGMIN89.8

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PTS Assessment Completion

Percentage of participants who completed post-thrombotic syndrome assessments (NCT01999179)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant17

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Number of Participants With Recurrent Thrombosis

Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

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Number of Participants With Post-thrombotic Syndrome

The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

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Number of Participants With Major Bleeding

Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant1

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Biomarker Sample Collection

Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis (NCT01999179)
Timeframe: 1 year

Interventionparticipants (Number)
Low-molecular-weight Heparin or Direct Oral Anticoagulant7

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Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death

(NCT02073682)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Edoxaban Group235
Dalteparin Group228

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Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period

(NCT02073682)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Edoxaban Group41
Dalteparin Group59

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Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period

(NCT02073682)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Edoxaban Group21
Dalteparin Group24

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Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period

(NCT02073682)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Edoxaban Group19
Dalteparin Group35

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Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event

(NCT02073682)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Edoxaban Group67
Dalteparin Group71

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Number of Participants With Adjudicated Major Bleeding Events While on Treatment

The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug). (NCT02073682)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Edoxaban Group32
Dalteparin Group16

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Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE). (NCT02585713)
Timeframe: Up to 3 months post-treatment

Interventionmonths (Median)
Arm A (Apixaban)NA
Arm B (Dalteparin)NA

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6 Month Bleeding Rate

The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. (NCT02585713)
Timeframe: Up to 6 months

Interventionpercentage of patients (Number)
Arm A (Apixaban)0
Arm B (Dalteparin)2.1

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Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed

A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. (NCT02585713)
Timeframe: Up to 6 months

Interventionpercentage of patients (Number)
Arm A (Apixaban)7.0
Arm B (Dalteparin)8.1

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Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)

To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form) (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)21.5
Randomized Arm 2 (LMWH)18.4
Preference Cohort 1 (DOACs)16.3
Preference Cohort 2 (LMWH)23.8

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Cumulative Rates of Major Bleeding

To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living). (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)5.2
Randomized Arm 2 (LMWH)5.6
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)7.6

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Cumulative Non-Fatal VTE Recurrence at 6 Months (%)

To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE. (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)6.1
Randomized Arm 2 (LMWH)8.8
Preference Cohort 1 (DOACs)7.5
Preference Cohort 2 (LMWH)4.1

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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.5
Randomized Arm 2 (LMWH)54.1
Preference Cohort 1 (DOACs)54.9
Preference Cohort 2 (LMWH)53.1

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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 3 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.7
Randomized Arm 2 (LMWH)53.3
Preference Cohort 1 (DOACs)55.8
Preference Cohort 2 (LMWH)54.9

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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 6-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.6
Randomized Arm 2 (LMWH)11.3
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)10.1

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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 3-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.2
Randomized Arm 2 (LMWH)10.7
Preference Cohort 1 (DOACs)10.3
Preference Cohort 2 (LMWH)10.5

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Number of Participants With Deep Venous Thromboembolism

DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy. (NCT02774265)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
VTE Prophylaxis With Enoxaparin 30mg BID5
VTE Prophylaxis With Aspirin 81mg BID9

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Number of Participants With Pulmonary Embolism Events

Bases on imaging obtained for symptoms. (NCT02774265)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
VTE Prophylaxis With Enoxaparin 30mg BID6
VTE Prophylaxis With Aspirin 81mg BID2

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The Number of Participants With Adjudicated CRNM Bleeding

"The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban1
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)2

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The Number of Participant Deaths in the Study

The number of participant deaths in the study. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban0
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)0

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Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng • h/mL (Geometric Mean)
Participants Weight Range 6 to < 9 kg1460
Participants Weight Range 9 to < 12 kg1840
Participants Weight Range 12 to < 18 kg1610
Participants Weight Range 18 to < 25 kg1760
Participants Weight Range 25 to < 35 kg1840
Participants Weight Range ≥ 35 kg1630

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Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events

"The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.~CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room." (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban1
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)3

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Maximum Observed Concentration (Cmax)

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng/mL (Geometric Mean)
Participants Weight Range 6 to < 9 kg185
Participants Weight Range 9 to < 12 kg218
Participants Weight Range 12 to < 18 kg222
Participants Weight Range 18 to < 25 kg244
Participants Weight Range 25 to < 35 kg249
Participants Weight Range ≥ 35 kg203

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The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)

"Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.~PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).~Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems." (NCT02981472)
Timeframe: from randomization up to 12 months after randomization

,
InterventionScore on a scale (Mean)
GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - BASELINEGENERAL-SPECIFIC MODULE ASSESSED BY CHILD - MONTH 12GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - BASELINEGENERAL-SPECIFIC MODULE ASSESSED BY PARENT - MONTH 12HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - BASELINEHEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - MONTH 12TREATMENT II ASSESSED BY CHILD - BASELINETREATMENT II ASSESSED BY CHILD - MONTH 12PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - BASELINEPERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - MONTH 12TREATMENT ANXIETY ASSESSED BY CHILD - BASELINETREATMENT ANXIETY ASSESSED BY CHILD - MONTH 12COGNITIVE PROBLEMS ASSESSED BY CHILD - BASELINECOGNITIVE PROBLEMS ASSESSED BY CHILD - MONTH 12COMMUNICATION ASSESSED BY CHILD - BASELINECOMMUNICATION ASSESSED BY CHILD - MONTH 12HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - BASELINEHEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - MONTH 12TREATMENT II ASSESSED BY PARENT - BASELINETREATMENT II ASSESSED BY PARENT - MONTH 12PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - BASELINEPERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - MONTH 12TREATMENT ANXIETY ASSESSED BY PARENT - BASELINETREATMENT ANXIETY ASSESSED BY PARENT - MONTH 12COGNITIVE PROBLEMS ASSESSED BY PARENT - BASELINECOGNITIVE PROBLEMS ASSESSED BY PARENT - MONTH 12COMMUNICATION ASSESSED BY PARENT - BASELINECOMMUNICATION ASSESSED BY PARENT - MONTH 12
Apixaban69.6473.3765.6170.0065.3469.4687.3991.7775.5180.5680.5280.7169.8568.2466.1570.3163.6866.3791.4190.3079.1679.3861.4464.0360.2958.6965.5768.20
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)60.7164.8165.4270.3264.7063.4485.6886.2778.4481.3760.3160.3153.2453.5363.5557.2867.7169.0085.2783.8079.6674.3356.2757.7761.6058.5367.3366.17

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The Number of Participants With Adjudicated Major Bleeding

"The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding is defined as bleeding that satisfies one or more of the following criteria:~fatal bleeding~clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period~bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS~bleeding that requires surgical intervention in an operating suite, including interventional radiology" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban1
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)1

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Chromogenic FX Assay (Apparent FX Level)

"Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.~125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose

InterventionPercent (Mean)
Day 1 (PREDOSE)Day 1 (4 HRS POSTDOSE)Week 2 (PREDOSE)Week 2 (2 HRS POSTDOSE)Month 3 (2 HRS POSTDOSE)Month 6 (PREDOSE)
Apixaban58.8718.9035.8821.2618.2536.57

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Anti-FXa Activity

"Anti-FXa Activity was measured to assess participant plasma apixaban levels.~125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng/mL (Mean)
Day 1 (4 HRS POSTDOSE)Week 2 (PREDOSE)Week 2 (2 HRS POSTDOSE)Month 3 (2 HRS POSTDOSE)Month 6 (PREDOSE)
Apixaban147.6986.24242.34228.8866.93

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Trough Observed Concentration (Cmin)

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng/mL (Geometric Mean)
Participants Weight Range 6 to < 9 kg57.9
Participants Weight Range 9 to < 12 kg82.7
Participants Weight Range 12 to < 18 kg64.3
Participants Weight Range 18 to < 25 kg67.4
Participants Weight Range 25 to < 35 kg73.1
Participants Weight Range ≥ 35 kg72.7

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Time of Maximum Observed Concentration (Tmax)

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionhours (Median)
Participants Weight Range 6 to < 9 kg2.24
Participants Weight Range 9 to < 12 kg2.47
Participants Weight Range 12 to < 18 kg1.72
Participants Weight Range 18 to < 25 kg1.74
Participants Weight Range 25 to < 35 kg1.65
Participants Weight Range ≥ 35 kg1.85

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The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding

The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban7
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)1

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The Number of Participants With All Adjudicated Bleeding

The number of participants with all adjudicated bleeding events (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban47
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)23

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Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score

"Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.~KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect." (NCT02981472)
Timeframe: from randomization up to 12 months after randomization

,
InterventionScore on a scale (Mean)
BASELINE CHILD REPORTED - 6 MONTHSPOST BASELINE CHILD REPORTED - 6 MONTHSBASELINE CHILD REPORTED - 12 MONTHSPOST BASELINE CHILD REPORTED - 12 MONTHSBASELINE PARENT REPORTED - 6 MONTHSPOST BASELINE PARENT REPORTED - 6 MONTHSBASELINE PARENT REPORTED - 12 MONTHSPOST BASELINE PARENT REPORTED - 12 MONTHS
Apixaban24.3522.8122.5021.5237.9732.3238.3731.10
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)26.4522.5725.3218.0139.0237.9439.3633.61

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Crossover Rate

Crossover rate between standard of care and experimental study arms. (NCT03100123)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Crossover Rate0

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Eligibility

Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria). (NCT03100123)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Screened Patients Who Met Eligibility Criteria4

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Essential Documents

Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents. (NCT03100123)
Timeframe: 18 months

InterventionSites (Number)
Approval Timeline1

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Study Drug Compliance

Level of compliance with study drug through patient recall and patient medication diary. (NCT03100123)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Standard of Care Arm0
Experimental Arm1

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Study Feasibility: Mean Recruitment Rate Per Center Per Month

The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month. (NCT03100123)
Timeframe: 24 months

Interventionparticipants (Number)
Experimental Arm1

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Withdrawals/Loss to Follow-up

Proportion of withdrawals/loss to follow-up among randomized patients. (NCT03100123)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Withdrawal/Lost to Follow-up0

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Provider Adherence in Implementation of PE Prevention Strategies.

Since thromboprophylaxis is often underused in China, investigators want to investigate provider adherence in complying with thromboprophylaxis implementation. Some provider, mainly surgeon, don't comply with currently used prevention strategies. Based on real prevention methods that patients have received during postoperative period, provider adherence are shown as percentage. When analyzing data, investigators need to exclude those patients who didn't receive proper prevention according to our guidelines from whole patients group. By studying adherence outcome, investigators will know in what extent the surgeon's decision will influence the result. (NCT03862755)
Timeframe: Through study completion, an average of 1 month

InterventionParticipants (Count of Participants)
ComplianceNon-compliance
Thromboprophylaxis306275

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Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.

Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE. (NCT03862755)
Timeframe: up to 8 weeks post operation

InterventionParticipants (Count of Participants)
Thromboprophylaxis3

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Re-hospitalization

Need for Re-hospitalization will be based on monitoring of patient conditions. (NCT04401293)
Timeframe: Day 30 ± 2 days.

InterventionParticipants (Count of Participants)
Full Dose LMWH Anticoagulation Therapy1
Prophylactic/Intermediate Dose LMWH or UFH Therapy3

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Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days.

Risk of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Day 30 ± 2 days. (NCT04401293)
Timeframe: Day 30 ± 2 days

InterventionParticipants (Count of Participants)
Full Dose LMWH Anticoagulation Therapy25
Prophylactic/Intermediate Dose LMWH or UFH Therapy31

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Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4

The composite of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Hospital Day 10 + 4 (NCT04401293)
Timeframe: Day 10 + 4

InterventionParticipants (Count of Participants)
Full Dose LMWH Anticoagulation Therapy2
Prophylactic/Intermediate Dose LMWH or UFH Therapy3

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Major Bleeding

Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria (NCT04401293)
Timeframe: Day 30 ± 2 days

InterventionParticipants (Count of Participants)
Full Dose LMWH Anticoagulation Therapy6
Prophylactic/Intermediate Dose LMWH or UFH Therapy2

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Need for Intubation

Need for Intubation will be based on monitoring of patient conditions. (NCT04401293)
Timeframe: Day 30 ± 2 days.

InterventionParticipants (Count of Participants)
Full Dose LMWH Anticoagulation Therapy17
Prophylactic/Intermediate Dose LMWH or UFH Therapy21

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Progression to Acute Respiratory Distress Syndrome (ARDS)

Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions. (NCT04401293)
Timeframe: Day 30 ± 2 days.

InterventionParticipants (Count of Participants)
Full Dose LMWH Anticoagulation Therapy11
Prophylactic/Intermediate Dose LMWH or UFH Therapy6

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Sepsis-induced Coagulopathy (SIC) Score

"Sepsis-induced coagulopathy (SIC) score predicts likelihood of sepsis-induced coagulopathy based on ISTH guidelines.~The score uses the following domains:~Platelets, K/uL (thousands per microliter)~INR (International Normalized Ratio)~D-Dimer Level~Fibrinogen~Platelet count > 100 cells x 10^9/L is 0 points, platelet count 50 to 100 cells x 10^9/L is 1 point and Platelet count < 50 cells x 10^9/L is 2 points. INR < 1.3 is 0 points, INR 1.3 to 1.7 is 1 point and INR > 1.7 is 2 points. D-Dimer level < 400 ng/mL is 0 points, D-Dimer level 400-4000 ng/mL is 2 points and D-Dimer level > 4000 ng/mL is 3 points. Fibrinogen level > 100 mg/dL is 0 points and fibrinogen level < 100 mg/dL is 1 point.~Calculated (SIC) scores yields a possible 0 to 6 points, where ≥4 predicts higher mortality rates within 30 days and greater risk of pulmonary embolism." (NCT04401293)
Timeframe: Day 30 ± 2 days.

Interventionunits on a scale (Mean)
Full Dose LMWH Anticoagulation Therapy2.35
Prophylactic/Intermediate Dose LMWH or UFH Therapy2.31

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