Page last updated: 2024-10-18

dalteparin and Respiratory Insufficiency

dalteparin has been researched along with Respiratory Insufficiency in 7 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)

Respiratory Insufficiency: Failure to adequately provide oxygen to cells of the body and to remove excess carbon dioxide from them. (Stedman, 25th ed)

Research Excerpts

Excerpt	Relevance	Reference
"In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2."	5.15	Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. ( Goldhaber, SZ; Haas, SK; Kakkar, AK; Knabb, RM; Leizorovicz, A; Merli, G; Weitz, JI, 2011)
"Severe and acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with a high mortality."	2.79	Efficacy of low molecular weight heparin in patients with acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support. ( Qian, Y; Tian, R; Wang, R; Xie, H; Yu, K, 2014)

Research

Studies (7)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	4 (57.14)	29.6817
2010's	3 (42.86)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Qian, Y	1
Xie, H	1
Tian, R	1
Yu, K	1
Wang, R	1
Peters, BJ	1
Hofer, M	1
Daniels, CE	1
Winters, JL	1
Goldhaber, SZ	1
Leizorovicz, A	3
Kakkar, AK	1
Haas, SK	1
Merli, G	1
Knabb, RM	1
Weitz, JI	1
Cohen, AT	3
Alikhan, R	2
Combe, S	2
Samama, MM	2
Desjardins, L	2
Eldor, A	2
Janbon, C	2
Olsson, CG	2
Turpie, AG	2
Morau, D	1
Barthelet, Y	1
Spilmann, E	1
d'Athis, F	1

Clinical Trials (3)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome[NCT04420312]		1,024 participants (Actual)	Observational	2020-03-01	Completed
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.[NCT00457002]	Phase 3	6,758 participants (Actual)	Interventional	2007-06-30	Completed
Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study[NCT02066454]	Phase 3	105 participants (Anticipated)	Interventional	2014-04-30	Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period

A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	2.36
Enoxaparin 40 mg	2.12

Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.22
Enoxaparin 40 mg	0.24

Incidence of Adjudicated PE With Onset During the Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.22
Enoxaparin 40 mg	0.24

Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	2.40
Enoxaparin 40 mg	2.50

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	6.44
Enoxaparin 40 mg	6.50

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	2.71
Enoxaparin 40 mg	2.93

Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period

Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.00
Enoxaparin 40 mg	0.15

Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.15
Enoxaparin 40 mg	0.49

Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.15
Enoxaparin 40 mg	0.37

Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	3.11
Enoxaparin 40 mg	3.46

Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants

Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1 to last dose of parenteral study drug plus 1 day

Intervention	Event rate (%) (Number)
Apixaban 2.5 mg	1.73
Enoxaparin 40 mg	1.61

Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants

Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1 to last dose of parenteral study drug plus 1 day

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	1.66
Enoxaparin 40 mg	1.51

Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period

Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	6.44
Enoxaparin 40 mg	6.63

Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.06
Enoxaparin 40 mg	0.09

Incidence of All Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of drug to last dose of drug plus 2 days

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	7.73
Enoxaparin 40 mg	6.81

Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	7.16
Enoxaparin 40 mg	6.83

Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days

Intervention	Event Rate (%): (Number)
Apixaban 2.5 mg	2.26
Enoxaparin 40 mg	1.90

Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population

VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event rate (%) (Number)
Apixaban 2.5 mg	2.71
Enoxaparin 40 mg	3.06

Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	2.67
Enoxaparin 40 mg	2.08

Incidence of Major Bleeding During the Treatment Period in Treated Participants

Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.47
Enoxaparin 40 mg	0.19

Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

Intervention	Event Rate (%) (Number)
Apixaban 2.5 mg	0.40
Enoxaparin 40 mg	0.80

Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants

Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	Event Rate (%) (Number)
	MI or stoke (N=3183, 3216)	MI (N=3184, 3217)	Stroke (N=3183, 3216)	Thrombocytopenia (N=3184, 3217)
Apixaban 2.5 mg	0.38	0.22	0.16	0.19
Enoxaparin 40 mg	0.37	0.12	0.25	0.09

Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period

Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	mmHg (Mean)
	Day of Discharge from Hospital (N=1607, 1625)	Day 30 of Treatment + 2 (N=2227,2301)
Apixaban 2.5 mg	-1.0	0.0
Enoxaparin 40 mg	-0.4	-0.5

Mean Change From Baseline in Heart Rate in Treated Participants

Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	bpm (Mean)
	Hospital Discharge (N=1606,1622)	Day 30 of treatment (N=2225,2299)
Apixaban 2.5 mg	-5.4	-4.0
Enoxaparin 40 mg	-5.1	-4.3

Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period

Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	mmHg (Mean)
	Discharge from Hospital (N=1607, 1625)	Day 30 of Treatment + 2 (N=2227, 2301)
Apixaban 2.5 mg	-3.0	-2.3
Enoxaparin 40 mg	-2.4	-2.9

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants

Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths. (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)

Intervention	participants (Number)
	AEs	SAEs	Bleeding AEs	Discontinuations Due to AE	Deaths
Apixaban 2.5 mg	1871	611	244	290	131
Enoxaparin 40 mg	1910	601	221	262	133

Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements

Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)

Intervention	participants (Number)
	Neurologic AEs	Neurologic SAEs	Liver-related AEs	Liver-related SAEs
Apixaban 2.5 mg	45	5	127	9
Enoxaparin 40 mg	42	1	142	12

Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants

Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	participants (Number)
	AST Elevation >3*ULN (N=2831, 2863)	ALT Elevation >3*ULN (N=2827, 2861)	AST + ALT >3*ULN on same date (N= 2827, 2861)	TBili >2*ULN (N= 2853, 2884)	ALT or AST >3ULN + TBili >2ULN (N=2818,2855)	ALT>3ULN + TBili >2ULN (N=2817, 2853)
Apixaban 2.5 mg	23	22	14	13	2	0
Enoxaparin 40 mg	28	32	13	14	2	2

Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants

Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	participants (Number)
	Calcium < 0.8*LLN (N=2861, 2893)	Calcium > 1.2*ULN (N=2861, 2893)	Chloride < 0.9*LLN (N=2861, 2886)	Chloride > 1.1*ULN (N=2861, 2886)	Bicarbonate < 0.75*LLN (N=2831, 2855)	Bicarbonate > 1.25*ULN (N=2831, 2855)	Potassium < 0.9*LLN (N=2851, 2878)	Potassium > 1.1*ULN (N=2851, 2878)	Sodium < 0.95*LLN (N=2862, 2888)	Sodium > 1.05*ULN (N=2862, 2888)
Apixaban 2.5 mg	6	3	25	5	5	6	61	140	23	9
Enoxaparin 40 mg	8	3	25	1	6	4	58	137	25	6

Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants

Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	participants (Number)
	Glucose Fasting <0.9*LLN (N=284,287)	Glucose Fasting > 1.5*ULN (N=284,287)	Total Protein < 0.9 *LLN (N=2864, 2890)	Total Protein > 1.1*ULN (N=2864, 2890)	Creatine kinase >5*ULN U/L(N=2856, 2888)	Uric acid > 1.5* ULN (N=2862, 2889)
Apixaban 2.5 mg	5	39	78	16	8	47
Enoxaparin 40 mg	3	30	51	8	10	44

Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants

Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	participants (Number)
	Hemoglobin >2 g/dL decrease (N=2835, 2871)	Hematocrit <0.75*PreRx (N=2688, 2722)	Platelet Count < 100*10^9 c/L (N=2761, 2799)	Erythrocytes <0.75*PreRx c/µL (N=2697, 2730)	Leukocytes <0.75*LLN (N= 2835, 2869)	Leukocytes > 1.25*ULN (N=2835, 2869)	Abs Eosinophils > 0.75*10^3 c/µL (N=20, 24)	Abs Lymphocytes < 0.750103 c/ µL (N=20, 24)	Abs Monocytes > 2000/MM^3 (N= 19, 25)
Apixaban 2.5 mg	133	23	9	28	64	331	1	4	1
Enoxaparin 40 mg	98	17	7	16	55	283	1	2	0

Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants

Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

Intervention	participants (Number)
	Alkaline phosphatase U/L > 2*ULN(N=2866, 2895)	ALT U/L > 3*ULN (N=2827, 2861)	AST U/L > 3*ULN (N=2831, 2863)	Bilirubin Direct mg/dL > 1.5*ULN (N=2782, 2821)	Bilirubin Total mg/dL > 2*ULN (N=2853, 2884)	BUN mg/dL > 1.5*ULN (N=2864, 2891)	Creatinine mg/dL > 1.5*ULN (N=2862, 2892)
Apixaban 2.5 mg	35	23	24	123	17	194	150
Enoxaparin 40 mg	47	33	29	106	15	188	156

Reviews

1 review available for dalteparin and Respiratory Insufficiency

Article	Year
Discoveries in thrombosis care for medical patients. Seminars in thrombosis and hemostasis, 2002, Volume: 28 Suppl 3 Topics: Clinical Trials as Topic; Cost-Benefit Analysis; Critical Care; Drug Costs; Enoxaparin; Fibrinolytic	2002

Trials

3 trials available for dalteparin and Respiratory Insufficiency

Article	Year
Efficacy of low molecular weight heparin in patients with acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support. COPD, 2014, Volume: 11, Issue:2 Topics: Acute Disease; Aged; Cohort Studies; Critical Care; Female; Fibrinolytic Agents; Humans; Length of S	2014
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. The New England journal of medicine, 2011, Dec-08, Volume: 365, Issue:23 Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat	2011
Prevention of venous thromboembolism in medical patients with enoxaparin: a subgroup analysis of the MEDENOX study. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis, 2003, Volume: 14, Issue:4 Topics: Aged; Aged, 80 and over; Anticoagulants; Chronic Disease; Dose-Response Relationship, Drug; Double-B	2003

Other Studies

3 other studies available for dalteparin and Respiratory Insufficiency

Article	Year
Effect of plasma exchange on antifactor Xa activity of enoxaparin and serum levetiracetam levels. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2018, Dec-01, Volume: 75, Issue:23 Topics: Enoxaparin; Factor Xa Inhibitors; Female; Humans; Levetiracetam; Lung Diseases, Interstitial; Middle	2018
Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study. Archives of internal medicine, 2004, May-10, Volume: 164, Issue:9 Topics: Acute Disease; Aged; Anticoagulants; Comorbidity; Enoxaparin; Female; Heart Failure; Hospitalization	2004
[Hematoma of the right rectus abdominis in relation to treatment with low-molecular-weight heparin]. Annales francaises d'anesthesie et de reanimation, 2000, Volume: 19, Issue:1 Topics: Aged; Anticoagulants; Dalteparin; Female; Hematoma; Humans; Injections, Subcutaneous; Muscular Disea	2000