OSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs. - NOSTRADAMUS

Academic Medical Center0 个研究点目标入组 1,334 人开始时间: 2006年7月28日最近更新: 2012年3月19日

试验速览

暂无简介。

•1) Subjects must be willing and able to give written informed consent
•2) Confirmed symptomatic DVT, i.e., proximal vein or extensive calf-vein
•thrombosis, involving at least the upper third part of the deep calf veins (trifurcation, AND/OR confirmed symptomatic PE, no longer than 2 months prior to randomization
•3) age 18 years or older
•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

•Target Disease Exceptions
•1. Previous episodes of DVT or PE
•2. Active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA
•3. Insertion of a caval filter to treat the episode of VTE
•Medical History and Concurrent Diseases
•4. Active cancer or anti-cancer treatment in the 6 months prior to the acute episode of VTE
•5. Life expectancy < 18 months
•6. Arterial thrombotic events in the context of a confirmed antiphospholipid antibody syndrome
•Prohibited Therapies and/or Medications
•7. Indications for VKA other than DVT

发起方

Academic Medical Center