First episode of deep vein thrombosis (DVT) or pulmonary embolism (PE).
Conditions
Interventions
Randomization between disclosure and undisclosure of results of thrombophilia screening and subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thr
Sponsors
ZonMw
Nederlandse Hartstichting (Dutch Heart foundation)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrent VTE 18 months after the acute episode of VTE | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrent VTE at the end of the study 2. A composite endpoint of recurrent VTE and bleeding at the end of the study 3. Quality of life 4. costs of testing and subsequent predefined prolongation of anticoagulant therapy | — |
Contacts
Public ContactS. Middeldorp
Academic Medical Center (AMC), Department of Vascular Medicine, F4-276, P.O. Box 22660
Outcome results
None listed