Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thromboembolism, Deep Vein Thrombosis, Dalteparin

Intervention / Treatment
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* Drug: Dalteparin sodium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Cancer Anticoagulant treatment in the previous 3 months Stroke or major surgery in the previous 3 months Systolic pressure >200 mmHg or diastolic pressure >120 mmHg Known chronic hepatopathy Active hemorrhage in any site in the previous 3 months Active peptic ulcer Bacterial endocarditis Conditions that can increase the risk of hemorrhage Known coagulation disorders Hypersensitivity to heparin or HIT Life expectancy of less than 3 months Previous confinement to bed during more than 3 days

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dalteparin sodium<br> | Drug: Dalteparin sodium<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period. |  | 1 month |