A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients

Study Overview
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Brief Summary
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This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.

Official Title
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A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients

Conditions
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Thromboembolism

Intervention / Treatment
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* Drug: Certoparin
* Drug: Unfractionated Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized medical patients 70 years of age or older Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) written informed consent Exclusion Criteria: immobilization longer than 3 days prior to randomization prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system expected major surgical or invasive procedure within the next 3 weeks after randomization LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization immobilization due to cast or fracture indication for anticoagulatory or thrombolytic therapy acute symptomatic DVT / PE known hypersensitivity to any of the study drugs or drugs with similar chemical structures Acute or history of heparin induced thrombocytopenia type II (HIT II) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certoparin<br> | Drug: Certoparin<br>* 3000 U anti XA of certoparin in 0.3 ml solution, once daily<br>* Other names: low molecular weight heparin;|
| Active Comparator: Unfractionated Heparin<br> | Drug: Unfractionated Heparin<br>* solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, |  | 20 days | 
| symptomatic DVT, |  | 20 days | 
| symptomatic non-fatal pulmonary embolism (PE), |  | 20 days | 
| combination of proximal DVT, non fatal PE and death from all causes including PE |  | 20 days | 
| VTE related death, |  | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous thromboembolism, Medical patients, Heparin, Low molecular weight heparin, Deep vein thrombosis, Certoparin, Embolism and Thrombosis