OSTRADAMUS: testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomised controlled trial to assess effects on clinical outcomes, quality of life, and costs

Completed

• Conditions: Pulmonary embolism, deep vein thrombosis; Circulatory System; Circulatory diseases

• Registration Number: ISRCTN07836779
• Lead Sponsor: Academic Medical Center (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1336

Inclusion Criteria

1. Subjects must be willing and able to give written informed consent
2. Confirmed symptomatic Deep Vein Thrombosis (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 Pulmonary Embolism (PE), no longer than two months prior to randomisation
3. Aged 18 years or older

Exclusion Criteria

1. Previous episodes of DVT or PE
2. Active bleeding or high risk for bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH), fondaparinux or Vitamin K Antagonists (VKA)
3. Insertion of a caval filter to treat the episode of VTE
4. Active cancer or anti-cancer treatment in the six months prior to the acute episode of VTE
5. Life expectancy less than 18 months
6. Arterial thrombotic events in the context of a confirmed antiphospholipid antibody syndrome
7. Indications for VKA other than DVT

Study & Design

• Study Type: Interventional
• Study Design: Not specified