Status:
COMPLETED
Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Conditions:
Thrombosis
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinz...
Detailed Description
Two studies demonstrated that out-of-hospital low-molecular-weight heparin given by twice daily subcutaneous injection without laboratory monitoring was as effective and as safe as continuous intraven...
Eligibility Criteria
Inclusion
- Patients having a first or recurrent episode of acute proximal vein thrombosis who are eligible for outpatient or home care during the initial therapy.
Exclusion
- Any condition which, in the opinion of the investigator, precludes entire out-of-hospital treatment
- Presence of familial bleeding diathesis or the presence of active bleeding contraindicating anticoagulant therapy
- Receiving therapeutic heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis
- Receiving long-term warfarin treatment
- Females who are pregnant
- Known allergy to heparin, warfarin sodium, or bisulfites
- History of heparin-associated thrombocytopenia
- Severe malignant hypertension
- Hepatic encephalopathy
- Severe renal failure
- Inability to attend follow-up due to geographic inaccessibility
- Inability or refusal to give signed informed consent
- Mothers who are breast-feeding and who are unable to refuse to discontinue breast-feeding during study treatment
Key Trial Info
Start Date :
April 1 1997
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00203658
Start Date
April 1 1997
End Date
October 1 2000
Last Update
February 9 2007
Active Locations (1)
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1
Thrombosis Research Unit, University of Calgary
Calgary, Alberta, Canada, T2N 2T9