Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

• Status: Terminated
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• Age > 65 years

• Confinement to bed for more than 3 days, due to:

• Heart failure

• Exacerbated chronic obstructive pulmonary disease

• Acute rheumatic involvement

• Written informed consent

Exclusion Criteria:

1. Cancer

2. Anticoagulant treatment in the previous 3 months

3. Stroke or major surgery in the previous 3 months

4. Systolic pressure >200 mmHg or diastolic pressure >120 mmHg

5. Known chronic hepatopathy

6. Active hemorrhage in any site in the previous 3 months

7. Active peptic ulcer

8. Bacterial endocarditis

9. Conditions that can increase the risk of hemorrhage

10. Known coagulation disorders

11. Hypersensitivity to heparin or HIT

12. Life expectancy of less than 3 months

13. Previous confinement to bed during more than 3 days