Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Thromboembolism; Dalteparin; Deep Vein Thrombosis

Treatments: Drug: Placebo; Drug: Dalteparin sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655122

FGMAEI-0042-046

A6301036

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

8 participants in 2 patient groups, including a placebo group

Dalteparin sodium

Active Comparator group

Treatment:

Drug: Dalteparin sodium

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo