Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00655122
• Other study ID #: FGMAEI-0042-046
• Secondary ID: A6301036
• Status: Terminated
• Phase: Phase 4
• First received: April 4, 2008
• Last updated: September 25, 2008
• Start date: April 2003
• Est. completion date: December 2003

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dalteparin
• Deep Vein Thrombosis
• Thromboembolism
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Dalteparin sodium
Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
• Placebo
Placebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.

Locations

Country	Name	City	State
Spain	Pfizer Investigational Site	Leon
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Parla
Spain	Pfizer Investigational Site	Torremolinos

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.		1 month	Yes

External Links

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