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

• Conditions: A randomized controlled trial of testing and no testing for thrombophilia in patients with a first episode of venous thrombosis or pulmonary embolism (venous thromboembolism, VTE) will be performed. Subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thrombophilia is detected in the testing group, while others will receive a standard predefined duration of treatment.; MedDRA version: 8.1Level: LLTClassification code 10047249Term: Venous thrombosis

• Registration Number: EUCTR2006-004199-11-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1334

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified