Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

Study Overview
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Brief Summary
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Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.

Official Title
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An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients

Conditions
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Embolism

Intervention / Treatment
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* Drug: Certoparin
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalization due to an acute non-surgical disease Significant decrease in mobility Exclusion Criteria: Indication for anticoagulant or thrombolytic therapy Major surgical or invasive procedure within the 4 weeks that precede randomization Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization Immobilization due to cast or fracture of lower extremity Immobilization lasting longer than 3 days in the period prior to randomization Heparin administration longer than 36 hours in the period prior to randomization Acute ischemic stroke Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Certoparin | Drug: Certoparin<br>* Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days<br>|
| Active Comparator: 2<br>Heparin | Drug: Heparin<br>* 7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment |  | 10 ± 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic events during follow-up period of 3 months |  | 90 days (± 7 days) after the end of the treatment | 
| Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies |  | 10 ± 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, thromboprophylaxis, medical patients, acutely ill, Acutely ill non surgical patients, Immobilization