OSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism (VTE): a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs.
Suspended
- Conditions
- First episode of deep vein thrombosis (DVT) or pulmonary embolism (PE).
- Registration Number
- NL-OMON25044
- Lead Sponsor
- ZonMwNederlandse Hartstichting (Dutch Heart foundation)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 1336
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
Exclusion Criteria
1. Previous episodes of DVT or PE
2. Active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method recurrent VTE 18 months after the acute episode of VTE
- Secondary Outcome Measures
Name Time Method 1. Recurrent VTE at the end of the study<br /><br>2. A composite endpoint of recurrent VTE and bleeding at the end of the study<br /><br>3. Quality of life<br /><br>4. costs of testing and subsequent predefined prolongation of anticoagulant therapy<br />