None listed
Conditions
Interventions
Group 1 Type of group
Dalteparinaa (Fragmin®) 5000 IU once a day for 14 days
Group name:Group 2 Type of group
Placebo 5000 IU once a day for 14 days
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Age:> 40 years of age. • Acute medical condition requiring a planned stay in the hospital> 4 days. • Recent immobilization (<3 days) defined as patients confined to bed during waking hours. • Signed informed consent. • Patients hospitalized for at least one of the following reasons: • Congestive heart failure (NYHA class III or IV) or acute respiratory failure not requiring support ventilation
Exclusion criteria
Exclusion criteria: • Previously randomized within this study. • Active participation known in another study in the process of research drugs or device protocol or during the past 30 days. • TVP / EP in the inclusion. • Hospitalization due to acute coronary syndrome (ACS) present or within the last month. • Anticipated procedure for major or invasive surgery (including epidural anesthesia or lumbar puncture) within the next 2 weeks. • Major or invasive surgery procedure within the last month. • Lumbar puncture and / or spinal / epidural anesthesia (including internal catheter) within the last 24 hours. • Bacterial endocarditis. • Lower limb immobilization due to cast or fracture splint. • Anticoagulation (other than LMWH or heparin) / direct thrombin inhibitors / thrombolytic therapy administered or completed within one week of randomization. • Prophylaxis with heparin or low molecular weight heparin (LMWH) administered less than 48 hours before inclusion. • Acute cerebrovascular accident within 3 months before entering the study. • Known bleeding bleeding or clinically significant coagulopathy. • Active major hemorrhage (see definition of protocol) within 3 months before entering the study. • Platelet count 200 umol / L or> 2.3 mg / dL). • Known hepatic insufficiency or active hepatitis defined as: transaminases (AST (TGOS), ALAT (TGPS))> 3 X ULN (upper normal limit). • serum albumin 1.5) • Jaundice (total bilirubin> 2.0 mg / dL or 34.2 umol / L). • History of hepatic encephalopathy. • History of ascites. • Known infection of the human immunodeficiency virus. • Uncontrolled hypertension (systolic blood pressure> 200 mmHg, diastolic blood pressure> 120 mmHg, or both). • Heparin-induced thrombocytopenia / LMWH experienced previously and / or known sensitivity to heparin. • Known pregnancy or breastfeeding. • Inability to follow the protocol and comply with the monitoring requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:These events will be verified by compression ultrasound (USC) or ascending venography. Measure:Symptomatic DVT objectively verified (proximal or distal events) for day 21. Timepoints:Day 21 ; Outcome name:Using ventilation-perfusion diagnostic gammagraphy (V / Q screening), pulmonary angiography, pulmonary computed tomography (CT), magnetic resonance imaging (MRI) or autopsy Measure:Symptomatic fatal or non-fatal EP by day 21 Timepoints:Day 21 ; Outcome name:Using USC or venography for day 21 + 3 (days 21 to 24). Measure:Non-symptomatic DVT Timepoints:Days 21 to 24 ; Outcome name:Sudden death (defined as unexpected death within 24 hours of the start of the event) for day 21. Measure:Sudden death Timepoints:Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Occurrence of: • Symptomatic VTE and sudden death • VTE • All DVT (proximal DVT and distal symptomatic DVT) • Proximal DVT • Distal symptomatic DVT • Symptomatic EP (fatal / non-fatal) Measure:VTE and DVT Timepoints:Day 14 and 21 ; Outcome name:Sudden death and every cause of death Measure:Death Timepoints:Days 14 and 21 ; Outcome name:Occurrence of adverse events and effect of Health Economics Measure:Occurrence of adverse events and effect of Health Economics Timepoints:Days 14 and 21 | — |
Outcome results
None listed