Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
NCT ID: NCT00655122
Last Updated: 2008-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
8 participants
INTERVENTIONAL
2003-04-30
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dalteparin sodium
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
León, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Parla, , Spain
Pfizer Investigational Site
Torremolinos, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6301036
Identifier Type: -
Identifier Source: secondary_id
FGMAEI-0042-046
Identifier Type: -
Identifier Source: org_study_id