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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
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
Incidence of symptomatic recurrent venous thromboembolism
Time frame: 12 months
Occurrence of major bleeding
Time frame: 6 month treatment interval
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