Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Phase 4

Terminated

• Conditions: Thromboembolism; Deep Vein Thrombosis; Dalteparin
• Interventions: Drug: Dalteparin sodium; Drug: Placebo

• Registration Number: NCT00655122
• Lead Sponsor: Pfizer

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-04
• Study Completion: 2003-12
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-09
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dalteparin sodium	Dalteparin sodium	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.	1 month

Secondary Outcome Measures

Name	Time	Method
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.	1 month

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Torremolinos, Spain