Multicentre, randomised, double blind, placebo controlled study on long-term treatment with Sulodexide for prevention of recurrent DVT in patients with venous thromboembolism - SURVET

Alfa Wassermann SpA0 个研究点目标入组 784 人开始时间: 2010年6月3日最近更新: 2015年3月9日

适应症

试验速览

暂无简介。

•Age = 18 years, of both sexes and any ethnical group
•Patients treated with anticoagulant therapy (with VKA) for 3- 12 months due to a
•documented (*) previous unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to sitting for more than 4 days and due to plaster, major trauma) DVT or PE
•(*)Proximal deep vein thrombosis (DVT) should have been diagnosed on the basis of
•evidence of thrombus in the popliteal or more proximal veins on compression
•ultrasonography or contrast venography, and pulmonary embolism by ventilation–
•perfusion lung scanning or helical computed tomography
•Ability to provide informed consent
•The signed informed consent must be obtained before starting any study procedure
•Female of a fertile age must have a negative urine pregnancy test and they should
•use a proper contraceptive method (IUD, barrier method; no oral contraceptives)
•during the entire duration of the trial
•Patients who stopped VKA therapy from more than 1 week and less than 3 months
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Secondary VTE (due to major/orthopaedic surgery, immobilization due to sitting for
•more than 4 days and due to plaster, major trauma)
•Current pregnancy or during puerperium (first 6 weeks after birth) at the time of
•examination for inclusion in the study
•Pulmonary embolism associated with shock or life-threatening prolonged hypotension or persistence of pulmonary hypertension after pulmonary embolism
•Two or more documented episodes of proximal VTE of lower limbs and/or
•pulmonary embolism
•DVT in areas other than lower limbs
•Isolated distal DVT (thrombosis of calf)
•Oral contraceptives taking
•Patients who stopped VKA therapy from less than 1 week and more than 3 months
•Solid neoplasia or blood disease in active phase or requiring
•chemotherapy/radiotherapy
•Antiphospholipid antibody syndrome as demonstrated by Sydney criteria;
•Antithrombin congenital deficit
•Need to continue VKA for whatever reason (linked to thrombotic event or other
•clinical indications)
•Severe cardio-respiratory insufficiency (Class NYHA 3 or 4)
•Limited life expectancy
•Geographically inaccessible location
•Inability or refusal to give consent
•Participation in another clinical trial with investigational drugs within the last 4
•weeks before screening or during the present trial period
•Known hypersensitivity towards glycosaminoglycans

发起方