The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.
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 6 months in patients with acute venous thrombosis. To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
acenocoumarol for 6 months
Pneumology Service. Hospital Clínico
Santiago de Compostela, A Coruña, Spain
Pneumology Service
Lugo, Lugo, Spain
Pneumology Service. Hospital Xeral Cies
Vigo, Pontevedra, Spain
Pneumology Service. Hospital do Meixoeiro
Vigo, Pontevedra, Spain
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
Time frame: 6 months
direct and indirect cost of each treatment regimen
Time frame: 6 months
Major haemorrhagic events
Time frame: 6 months
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