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

• Conditions: blood clots; 10083624; 10014523; venous thrombosis

• Registration Number: NL-OMON29979
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• 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
3) age 18 years or older

Exclusion Criteria

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
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
7. Indications for VKA other than DVT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome consists of:<br /><br>*recurrent VTE 18 months after the acute episode of VTE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy outcomes are:<br /><br>* recurrent VTE at the end of the study.<br /><br>* a composite endpoint of recurrent VTE and bleeding at the end of the study<br /><br>* quality of life<br /><br>* costs of testing and subsequent predefined prolongation of anticoagulant<br /><br>therapy</p><br>