Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care

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.

The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.

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