dalteparin has been researched along with Kidney Diseases in 43 studies
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)
Kidney Diseases: Pathological processes of the KIDNEY or its component tissues.
Excerpt | Relevance | Reference |
---|---|---|
"Oral dabigatran etexilate is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement or total hip replacement." | 7.76 | Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement. ( Brenkel, IJ; Clemens, A; Dolan, G; Noack, H; Plumb, JM; Robinson, PA; Roskell, NS; Wolowacz, SE, 2010) |
" 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." | 6.82 | 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) |
"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." | 5.36 | 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) |
"Oral dabigatran etexilate is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement or total hip replacement." | 3.76 | Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement. ( Brenkel, IJ; Clemens, A; Dolan, G; Noack, H; Plumb, JM; Robinson, PA; Roskell, NS; Wolowacz, SE, 2010) |
"RI in patients with cancer-associated thrombosis on anticoagulation was associated with a statistically significant increase in recurrent VTE and major bleeding, but no significant increase in CRB or mortality." | 2.87 | Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. ( Bauersachs, R; Janas, MS; Jarner, MF; Kamphuisen, PW; Khorana, AA; Lee, AYY; Meyer, G, 2018) |
" 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." | 2.82 | 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) |
" It is a hydrophilic molecule that is, predominantly, eliminated renally with few data to support dosing for subjects with renal impairment and/or obesity." | 2.75 | 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) |
"Data were obtained from a randomized controlled trial (n = 118) that compared conventional dosing of enoxaparin (product label) with an individualized dosing regimen." | 2.74 | Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events. ( Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2009) |
"Dalteparin was injected s." | 2.74 | Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. ( Brodmann, D; Fischer, AG; Schmid, P; Wuillemin, WA, 2009) |
"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." | 2.71 | 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) |
"Subjects were administered dalteparin at a dosage of approximately 100 U/kg subcutaneously every 12 hours." | 2.71 | 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) |
" 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." | 2.50 | [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) |
" 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." | 2.40 | Nadroparin calcium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders. ( Davis, R; Faulds, D, 1997) |
"The management of a patient with venous thrombosis with perinephric hematoma post renal biopsy can be difficult if occurred." | 1.72 | Double trouble - management of perinephric hematoma and renal vein thrombosis post percutaneous renal biopsy. ( Daud, MAM; Kamarudin, MI; Nadarajan, C, 2022) |
"Only cases with renal failure, morbid obesity or extreme age require anti-Xa monitoring to assure the therapeutic level achievement." | 1.36 | Stability of plasma anti-Xa activity in low-molecular-weight heparin monitoring. ( Akkawat, B; Juntiang, J; Rojnuckarin, P, 2010) |
"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." | 1.36 | 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) |
"Subjects with ESRD had an approximately 50% greater anticoagulant effect, determined by thrombin generation time prolongation, than controls at antifactor Xa activity concentrations of 0." | 1.32 | Enhanced anticoagulant activity of enoxaparin in patients with ESRD as measured by thrombin generation time. ( Brophy, DF; Carr, ME; Gehr, TW; Martin, EJ, 2004) |
"There are limited data on dosing of enoxaparin in patients with renal disease due to the routine exclusion of this population in clinical trials." | 1.32 | Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease. ( Jackevicius, CA; Ma, JM; Yeo, E, 2004) |
" Only pharmacokinetic studies exist to guide dose adjustment in response to anti-Xa levels." | 1.32 | Retrospective evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment. ( Kruse, MW; Lee, JJ, 2004) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 1 (2.33) | 18.2507 |
2000's | 20 (46.51) | 29.6817 |
2010's | 19 (44.19) | 24.3611 |
2020's | 3 (6.98) | 2.80 |
Authors | Studies |
---|---|
Derlatka, P | 1 |
Bidzinski, M | 1 |
Stachurska, E | 1 |
Benke, M | 1 |
Davis, R | 1 |
Faulds, D | 1 |
Del Peso, G | 1 |
Bajo, MA | 1 |
Fontán, MP | 1 |
Martínez, J | 1 |
Marrón, B | 1 |
Selgas, R | 1 |
Christidou, FN | 1 |
Frangia, TK | 1 |
Bamichas, GI | 1 |
Gionanlis, LC | 1 |
Natse, TA | 1 |
Georgoulis, IE | 1 |
Sombolos, KI | 1 |
Faour, WH | 1 |
Choaib, A | 1 |
Issa, E | 1 |
Choueiry, FE | 1 |
Shbaklo, K | 1 |
Alhajj, M | 1 |
Sawaya, RT | 1 |
Harhous, Z | 1 |
Alefishat, E | 1 |
Nader, M | 1 |
Kamarudin, MI | 1 |
Nadarajan, C | 1 |
Daud, MAM | 1 |
Weitz, JI | 1 |
Raskob, GE | 1 |
Spyropoulos, AC | 1 |
Spiro, TE | 1 |
De Sanctis, Y | 1 |
Xu, J | 1 |
Lu, W | 1 |
Suh, E | 1 |
Argenti, D | 1 |
Yang, H | 1 |
Albanese, J | 1 |
Lipardi, C | 1 |
Barnathan, ES | 1 |
Gökce, M | 1 |
Kuskonmaz, B | 1 |
Cetin, M | 1 |
Uckan Cetinkaya, D | 1 |
Tuncer, M | 1 |
Mele, M | 1 |
Mele, A | 1 |
La Torre, PP | 1 |
Cannone, M | 1 |
Freer, JM | 1 |
Green, MS | 1 |
Iuppa, JA | 1 |
Deal, EN | 1 |
Thoelke, MS | 1 |
Sacha, GL | 1 |
Greenlee, KM | 1 |
Ketz, JM | 1 |
Al-Sallami, H | 1 |
Ferguson, R | 1 |
Wilkins, G | 1 |
Gray, A | 1 |
Medlicott, NJ | 1 |
White, HD | 1 |
Gallo, R | 1 |
Cohen, M | 2 |
Steg, PG | 1 |
Aylward, PE | 1 |
Bode, C | 1 |
Steinhubl, S | 1 |
Montalescot, G | 1 |
Rojnuckarin, P | 1 |
Akkawat, B | 1 |
Juntiang, J | 1 |
Barras, MA | 2 |
Duffull, SB | 2 |
Atherton, JJ | 2 |
Green, B | 3 |
Wolowacz, SE | 1 |
Roskell, NS | 1 |
Plumb, JM | 1 |
Clemens, A | 1 |
Noack, H | 1 |
Robinson, PA | 1 |
Dolan, G | 1 |
Brenkel, IJ | 1 |
Leil, TA | 1 |
Feng, Y | 1 |
Zhang, L | 1 |
Paccaly, A | 1 |
Mohan, P | 1 |
Pfister, M | 1 |
Tsang, DJ | 1 |
Tuckfield, A | 1 |
Macisaac, CM | 1 |
Dufour, B | 1 |
Toussaint-Hacquard, M | 1 |
Kearney-Schwartz, A | 1 |
Manckoundia, MD | 1 |
Laurain, MC | 1 |
Joly, L | 1 |
Deibener, J | 1 |
Wahl, D | 1 |
Lecompte, T | 1 |
Benetos, A | 1 |
Perret-Guillaume, C | 1 |
Spinler, SA | 1 |
Inverso, SM | 1 |
Goodman, SG | 1 |
Stringer, KA | 1 |
Antman, EM | 1 |
Borawski, J | 1 |
Naumnik, B | 1 |
Myśliwiec, M | 1 |
Brophy, DF | 2 |
Martin, EJ | 2 |
Gehr, TW | 2 |
Carr, ME | 2 |
Best, AM | 1 |
Ma, JM | 1 |
Jackevicius, CA | 1 |
Yeo, E | 1 |
Kruse, MW | 1 |
Lee, JJ | 1 |
Kozlovskaia, NL | 1 |
Shakhnova, EA | 1 |
Kushnir, VV | 1 |
Shilov, EM | 1 |
Greenwood, M | 1 |
Saltissi, D | 1 |
Westhuyzen, J | 1 |
Kluver, L | 1 |
Rowell, J | 1 |
Atherton, J | 1 |
Nagge, J | 1 |
Fernandes, O | 1 |
Huh, J | 1 |
Spinler, S | 1 |
Nasser, NJ | 1 |
Abadi, S | 1 |
Azzam, ZS | 1 |
Lile, J | 1 |
Woodruff, S | 1 |
Feugère, G | 1 |
Abreu, P | 1 |
Heissler, J | 1 |
Ruiz, MT | 1 |
Jen, F | 1 |
Schmid, P | 1 |
Brodmann, D | 1 |
Fischer, AG | 1 |
Wuillemin, WA | 1 |
Haines, ST | 1 |
Dager, WE | 1 |
Trujillo, TC | 1 |
Näsström, B | 1 |
Stegmayr, B | 1 |
Olivecrona, G | 2 |
Olivecrona, T | 2 |
Shprecher, AR | 1 |
Cheng-Lai, A | 1 |
Madsen, EM | 1 |
Cohen, HW | 1 |
Sinnett, MJ | 1 |
Wong, ST | 1 |
Billett, HH | 1 |
Bauersachs, R | 1 |
Lee, AYY | 1 |
Kamphuisen, PW | 1 |
Meyer, G | 1 |
Janas, MS | 1 |
Jarner, MF | 1 |
Khorana, AA | 1 |
Mahmood, D | 3 |
Stegmayr, BG | 3 |
Projean, D | 1 |
Lalonde, S | 1 |
Morin, J | 1 |
Nogues, E | 1 |
Séguin, A | 1 |
Vincent, A | 1 |
Lafrance, JP | 1 |
Masson, V | 1 |
Kassis, J | 1 |
Fafard, J | 1 |
Lordkipanidzé, M | 1 |
Grubbström, M | 1 |
Lundberg, LD | 1 |
Siguret, V | 1 |
Gouin-Thibault, I | 1 |
Pautas, E | 1 |
Leizorovicz, A | 1 |
Jonsson, P | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study[NCT00571649] | Phase 3 | 8,101 participants (Actual) | Interventional | 2007-12-31 | Completed | ||
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk[NCT02111564] | Phase 3 | 12,024 participants (Actual) | Interventional | 2014-01-07 | Completed | ||
An International Phase 2-3, Stratified, Randomized, Open-label, Parallel-group Clinical Trial to Evaluate the Safety and Efficacy of a Single Intravenous Bolus of Enoxaparin Versus Intravenous Unfractionated Heparin in Patients Undergoing Non-emergent Per[NCT00077844] | Phase 2/Phase 3 | 3,532 participants (Anticipated) | Interventional | 2004-01-31 | Completed | ||
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function[NCT00264693] | 96 participants (Actual) | Observational | 2006-01-31 | Completed | |||
Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT[NCT01130025] | Phase 3 | 900 participants (Actual) | Interventional | 2010-08-31 | Completed | ||
Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses[NCT02719418] | 28 participants (Actual) | Observational | 2016-02-01 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.4 |
Enoxaparin | 5.7 |
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related). (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 8.6 |
Enoxaparin | 9.2 |
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 2.7 |
Enoxaparin | 2.7 |
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 3.0 |
Enoxaparin | 3.1 |
Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.5 |
Enoxaparin | 3.9 |
Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events. (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 9.4 |
Enoxaparin | 7.8 |
Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 2.8 |
Enoxaparin | 1.2 |
Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.1 |
Enoxaparin | 1.7 |
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related). (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.8 |
Enoxaparin | 4.5 |
All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths. (NCT00571649)
Timeframe: Up to Day 90 + 7 days
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Any event | Death (cardiovascular) | Death (other) | VTE related death | |
Enoxaparin | 6.2 | 1.4 | 3.7 | 1.1 |
Rivaroxaban (Xarelto, BAY59-7939) | 6.7 | 1.4 | 4.3 | 1.0 |
The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Symptomatic non-fatal PE | Symptomatic DVT in lower extremity | Asymptomatic proximal DVT in lower extremity | VTE related death | |
Enoxaparin | 0.1 | 0.2 | 2.4 | 0.2 |
Rivaroxaban (Xarelto, BAY59-7939) | 0.2 | 0.2 | 2.4 | 0.1 |
The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Symptomatic non-fatal PE | Symptomatic DVT in lower extremity | Asymptomatic proximal DVT in lower extremity | VTE related death | |
Enoxaparin | 0.5 | 0.5 | 4.4 | 1.0 |
Rivaroxaban (Xarelto, BAY59-7939) | 0.3 | 0.4 | 3.5 | 0.6 |
Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category. (NCT00571649)
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Intervention | Percentage of participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Any event-Day 10 | Ischemic stroke-Day 10 | Acute MI-Day 10 | Death (cardiovascular)-Day 10 | Any event-Day 35 | Ischemic stroke-Day 35 | Acute MI-Day 35 | Death (cardiovascular)-Day 35 | Any event-Day 90 | Ischemic stroke-Day 90 | Acute MI-Day 90 | Death (cardiovascular)-Day 90 | |
Enoxaparin | 1.0 | 0.3 | 0.4 | 0.4 | 1.6 | 0.5 | 0.5 | 0.8 | 2.8 | 1.1 | 0.7 | 1.4 |
Rivaroxaban (Xarelto, BAY59-7939) | 1.0 | 0.3 | 0.5 | 0.4 | 1.8 | 0.5 | 0.6 | 0.9 | 2.8 | 0.8 | 0.9 | 1.4 |
Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90 (NCT00571649)
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Intervention | Percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
symptomatic VTE (incl. VTE-related death)-Day 10 | symptomatic VTE (non fatal)-Day 10 | symptomatic VTE (incl. VTE-related death)-Day 35 | symptomatic VTE (non fatal)-Day 35 | symptomatic VTE (incl. VTE-related death)-Day 90 | symptomatic VTE (non fatal)-Day 90 | |
Enoxaparin | 0.6 | 0.3 | 1.4 | 0.7 | 1.9 | 0.9 |
Rivaroxaban (Xarelto, BAY59-7939) | 0.7 | 0.5 | 1.0 | 0.6 | 1.7 | 0.7 |
Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 1.19 |
Placebo | 1.49 |
Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 0.72 |
Placebo | 0.77 |
Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 1.31 |
Placebo | 1.80 |
Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 1.58 |
Placebo | 2.03 |
Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 0.19 |
Placebo | 0.42 |
A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days. (NCT02111564)
Timeframe: From randomization to 2 days after the last dose (Day 45)
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 0.28 |
Placebo | 0.15 |
Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45
Intervention | Events per 100 participants in 45 days (Number) |
---|---|
Rivaroxaban 10 mg or 7.5 mg | 0.84 |
Placebo | 1.11 |
3 reviews available for dalteparin and Kidney Diseases
Article | Year |
---|---|
Nadroparin calcium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders.
Topics: Absorption; Aging; Anticoagulants; Chemical Fractionation; Cost-Benefit Analysis; Dose-Response Rela | 1997 |
Mechanisms of COVID-19-induced kidney injury and current pharmacotherapies.
Topics: Acute Kidney Injury; Aldosterone; Angiotensins; Antibodies, Monoclonal, Humanized; Autopsy; Biopsy; | 2022 |
[Safe dose rTPA for massive pulmonary embolism associated with high bleeding risk: a case report and review of the literature].
Topics: Aged, 80 and over; Anemia, Hypochromic; Anticoagulants; Bundle-Branch Block; Diabetes Complications; | 2014 |
17 trials available for dalteparin and Kidney Diseases
Article | Year |
---|---|
Nadroparine activated fibrinolysis and improvement of glomerular filtration rate in patients with FIGO IIB-IIIB cervical cancer treated with radiochemotherapy.
Topics: Adult; Aged; Aged, 80 and over; Cisplatin; Combined Modality Therapy; Female; Fibrinolysis; Fibrinol | 2007 |
Effect of self-administered intraperitoneal bemiparin on peritoneal transport and ultrafiltration capacity in peritoneal dialysis patients with membrane dysfunction. A randomized, multi-centre open clinical trial.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Female; Hemorrhage; Heparin, Low-Molecular-Weight; H | 2012 |
Comparison of two low-molecular weight heparins (LMWHs), tinzaparin and bemiparin, during hemodialysis.
Topics: Adult; Blood Coagulation; Chronic Disease; Drug Administration Schedule; Factor Xa; Factor Xa Inhibi | 2005 |
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In | 2020 |
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In | 2020 |
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In | 2020 |
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In | 2020 |
The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial.
Topics: Aged; Angioplasty, Balloon, Coronary; Anticoagulants; Elective Surgical Procedures; Enoxaparin; Fema | 2009 |
Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events.
Topics: Anticoagulants; Dose-Response Relationship, Drug; Enoxaparin; Female; Hemorrhage; Humans; Kidney; Ki | 2009 |
Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations.
Topics: Algorithms; Anticoagulants; Drug Monitoring; Enoxaparin; Humans; Kidney Diseases; Models, Statistica | 2010 |
Activation of hepatocyte growth factor/activin A/follistatin system during hemodialysis: role of heparin.
Topics: Activins; Aged; Anticoagulants; Enoxaparin; Enzyme-Linked Immunosorbent Assay; Female; Follistatin; | 2003 |
Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes.
Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Anticoagulants; Coronary Disease; Enoxapa | 2005 |
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.
Topics: Acenocoumarol; Administration, Oral; Adult; Aged; Aged, 80 and over; Anticoagulants; Dalteparin; Fem | 2016 |
Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function.
Topics: Aged; Aged, 80 and over; Anticoagulants; Cohort Studies; Dalteparin; Drug-Related Side Effects and A | 2009 |
Peak antifactor xa activity produced by dalteparin treatment in patients with renal impairment compared with controls.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Case-Control Studies; Dalteparin; Factor Xa; Female; | 2005 |
Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Drug Administration Schedule; Female; Fibrinolytic Agent | 2018 |
Haemodialysis with Tinzaparin Versus Dialysate Citrate as Anticoagulation.
Topics: Aged; Aged, 80 and over; Anticoagulants; C-Reactive Protein; Cholesterol, LDL; Citric Acid; Dialysis | 2018 |
Lipoprotein lipase responds similarly to tinzaparin as to conventional heparin during hemodialysis.
Topics: Aged; Biomarkers; Drug Substitution; Female; Follow-Up Studies; Heparin; Heparin, Low-Molecular-Weig | 2010 |
No accumulation of the peak anti-factor Xa activity of tinzaparin in elderly patients with moderate-to-severe renal impairment: the IRIS substudy.
Topics: Aged; Aged, 80 and over; Factor Xa Inhibitors; Female; Fibrinolytic Agents; Heparin, Low-Molecular-W | 2011 |
A significant proportion of patients treated with citrate containing dialysate need additional anticoagulation.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anticoagulants; Blood Coagulation; Citric Acid; Cross-Ov | 2013 |
23 other studies available for dalteparin and Kidney Diseases
Article | Year |
---|---|
Double trouble - management of perinephric hematoma and renal vein thrombosis post percutaneous renal biopsy.
Topics: Adult; Biopsy; Enoxaparin; Gastrointestinal Hemorrhage; Hematoma; Hematuria; Humans; Kidney Diseases | 2022 |
Coexisting or underlying risk factors of hepatic veno-occlusive disease in pediatric hematopoietic stem cell transplant recipients receiving prophylaxis.
Topics: Administration, Oral; Adolescent; Age Factors; Amphotericin B; Anticoagulants; Antifungal Agents; Bu | 2013 |
Analysis of enoxaparin dose titration at a large, tertiary teaching facility.
Topics: Adult; Aged; Dose-Response Relationship, Drug; Enoxaparin; Female; Hospitals, Teaching; Humans; Kidn | 2015 |
The use of anti-factor Xa monitoring in a selection of patients receiving enoxaparin at a large academic medical center.
Topics: Adult; Aged; Aged, 80 and over; Drug Monitoring; Enoxaparin; Factor Xa Inhibitors; Female; Humans; K | 2016 |
Bleeding events in patients receiving enoxaparin for the management of non-ST-elevation acute coronary syndrome (NSTEACS) at Dunedin Public Hospital, New Zealand.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Case-Control Studies; Clinical Trials as Topic; Coro | 2008 |
Stability of plasma anti-Xa activity in low-molecular-weight heparin monitoring.
Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anticoagulants; Blood Preservation; Child; | 2010 |
Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement.
Topics: Aged; Aged, 80 and over; Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, | 2010 |
Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose.
Topics: Aged; Area Under Curve; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Com | 2010 |
Audit of safety and quality of the use of enoxaparin for anticoagulation in continuous renal replacement therapy.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; APACHE; Enoxaparin; Hemofiltration; Humans; Intensiv | 2011 |
Glomerular filtration rate estimated by Cockcroft-Gault formula better predicts anti-Xa levels than modification of the diet in renal disease equation in older patients with prophylactic enoxaparin.
Topics: Aged; Aged, 80 and over; Anticoagulants; Body Weight; Cohort Studies; Creatinine; Diet; Enoxaparin; | 2012 |
Safety and efficacy of unfractionated heparin versus enoxaparin in patients who are obese and patients with severe renal impairment: analysis from the ESSENCE and TIMI 11B studies.
Topics: Aged; Anticoagulants; Coronary Disease; Enoxaparin; Female; Fibrinolytic Agents; Heparin; Humans; Ki | 2003 |
Enhanced anticoagulant activity of enoxaparin in patients with ESRD as measured by thrombin generation time.
Topics: Adult; Anticoagulants; Blood Coagulation; Blood Coagulation Tests; Chronic Disease; Enoxaparin; Fact | 2004 |
Antifactor Xa activity correlates to thrombin generation time, platelet contractile force and clot elastic modulus following ex vivo enoxaparin exposure in patients with and without renal dysfunction.
Topics: Adult; Anticoagulants; Blood Coagulation Tests; Blood Platelets; Chronic Disease; Dose-Response Rela | 2004 |
Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Coronary Disease; Drug Administration | 2004 |
Retrospective evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment.
Topics: Aged; Aged, 80 and over; Anticoagulants; Enoxaparin; Factor Xa; Female; Humans; Kidney Diseases; Mal | 2004 |
[Low-molecular heparins in the treatment of APS-nephropathy in primary and secondary antiphospholipid syndrome].
Topics: Adult; Anticoagulants; Antiphospholipid Syndrome; Case-Control Studies; Enoxaparin; Female; Humans; | 2004 |
Evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment.
Topics: Anticoagulants; Enoxaparin; Factor Xa; Humans; Kidney Diseases; Program Evaluation | 2005 |
Adjusting the dose of low molecular weight heparins in renally impaired and obese patients.
Topics: Anticoagulants; Biomarkers; Cardiovascular Diseases; Comorbidity; Creatinine; Dose-Response Relation | 2004 |
Acute renal infarction from a cardiac thrombus.
Topics: Abdominal Pain; Acute Disease; Anticoagulants; Cardiomyopathy, Dilated; Coronary Thrombosis; Diagnos | 2007 |
Low-molecular-weight heparin administration in patients with end-stage renal disease--a comment.
Topics: Anticoagulants; Blood Transfusion; Enoxaparin; Hemorrhage; Humans; Kidney Diseases; Kidney Failure, | 2001 |
Clinical and management challenges in preventing venous thromboembolism in health systems: a case-based panel discussion.
Topics: Aged; Anticoagulants; Arthroplasty, Replacement, Hip; Bariatric Surgery; Colonic Neoplasms; Daltepar | 2010 |
Lipoprotein lipase in hemodialysis patients: indications that low molecular weight heparin depletes functional stores, despite low plasma levels of the enzyme.
Topics: Aged; Area Under Curve; Dalteparin; Heparin; Humans; Kidney Diseases; Lipoprotein Lipase; Reference | 2004 |
Study of the bioaccumulation of tinzaparin in renally impaired patients when given at prophylactic doses - The STRIP study.
Topics: Aged; Aged, 80 and over; Anticoagulants; Humans; Kidney Diseases; Tinzaparin | 2019 |