Status:
COMPLETED
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
LEO Pharma
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
Detailed Description
The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants g...
Eligibility Criteria
Inclusion
- Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
- either sex and over 18 years of age
- referred to the Vascular Surgery Department of the hospital
- onset of symptoms less than 2 weeks
- documented by compression ultrasonography,
Exclusion
- received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
- pulmonary embolism requiring thrombolytic therapy
- Need of surgical thrombectomy or vena cava interruption
- receiving oral anticoagulant treatment or antiplatelet agents for other conditions
- contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
- platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
- severe renal failure necessitating dialysis
- pregnancy
- lumbar puncture within the previous 24 hours
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00689520
Start Date
January 1 2002
End Date
January 1 2005
Last Update
June 3 2008
Active Locations (2)
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1
Vascular surgery service. Hospital Creu Roja de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
2
Department of Vascular Surgery. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907