Status:
TERMINATED
Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
Lead Sponsor:
Pfizer
Conditions:
Thromboembolism
Deep Vein Thrombosis
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 hrom...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00655122
Start Date
April 1 2003
End Date
December 1 2003
Last Update
September 29 2008
Active Locations (5)
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1
Pfizer Investigational Site
León, Spain, 24005
2
Pfizer Investigational Site
Madrid, Spain, 28001
3
Pfizer Investigational Site
Madrid, Spain
4
Pfizer Investigational Site
Parla, Spain