Residual Vein Thrombosis and the Optimal Duration of Low Molecular Weight Heparin in Cancer Patients With Deep Vein Thrombosis (Cancer-DACUS)
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ClinicalTrials.gov Identifier: NCT00450645
Recruitment Status : Unknown
Verified March 2009 by Azienda Ospedaliera Universitaria Policlinico. Recruitment status was: Recruiting
The duration of anticoagulant treatment in cancer patients with Deep Vein Thrombosis (DVT) of the lower limbs is still uncertain. The present study addresses the possible role of the Residual Vein Thrombosis (RVT) for establishing the optimal duration of Low Molecular Weight Heparin (LMWH). Patients with a first episode of symptomatic unprovoked or provoked proximal DVT will received LMWHs for 6 months; RVT, ultrasonographically-detected, will be then assessed. Patients without RVT stop LMWH, whereas those with RVT will be randomized to either stop or continue OAT for additional 6 months. Patients were followed-up at least 1 year after anticoagulant discontinuation focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding
LMWH were continued for additional 6 months after detection of residual vein thrombosis (6 months after the index deep vein thrombosis) in patients randomized to group A. LMWH are stopped in patients randomized to group B or in those patients without residual vein thrombosis after 6 months from the index DVT. Dosage of LMWH are 75% of the therapeutic dosage (almost 1 mg/Kg every 12 hours)
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Cancer patients with a first episode of symptomatic proximal DVT of the lower limbs
No signs of unstable pulmonary embolism
Indication to antithrombotic therapy/OAT for > 6 months (i.e. valvular prothesis, atrial fibrillation etc.)
Hypersensitivity to contrast media
Life expectancy < 1 year
Patients who are unable to fulfill study requirements as for repeated clinical controls