PROFILAXIS OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH ACUTE MEDICAL CONDITIONS REQUIRING PROLONGED IMMOBILIZATION: A COMPARISON OF THERAPINE (FRAGMIN) 5000 U. VERSUS PLACEBO IN A DOUBLE BLIND STUDY RANDOMIZED MULTICENTER

Not Applicable

• Conditions: -I82; I82

• Registration Number: PER-052-01
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-08-03
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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 <100 x 10 9 / L
• Known renal insufficiency (that is, serum creatinine> 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 <3.5 g / dL or 35 g / L.
• High prothrombin time (TNI> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified