Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
- Registration Number
- NCT00689520
- Lead Sponsor
- Hospital Universitari de Bellvitge
- 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 given for a similar period of time in patients with proximal venous thrombosis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tinzaparin tinzaparin tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months. acenocoumarol acenocoumarol tinzaparin for 1 weeks followed by acenocoumarol for 6 months
- Primary Outcome Measures
Name Time Method Incidence of symptomatic recurrent venous thromboembolism 12 months
- Secondary Outcome Measures
Name Time Method Occurrence of major bleeding 6 month treatment interval
Trial Locations
- Locations (2)
Vascular surgery service. Hospital Creu Roja de l'Hospitalet
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Department of Vascular Surgery. Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain