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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Calcium heparin; Certoparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

1. Hospitalized medical patients 70 years of age or older

2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)

3. written informed consent

Exclusion Criteria:

1. immobilization longer than 3 days prior to randomization

2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system

3. expected major surgical or invasive procedure within the next 3 weeks after randomization

4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization

5. immobilization due to cast or fracture

6. indication for anticoagulatory or thrombolytic therapy

7. acute symptomatic DVT / PE

8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures

9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply