(Recurrent) Venous thromboembolism
Conditions
Interventions
Formalization of guidelines on duration of treatment, based on outcome of VTE recurrence prediction model compared to care-as-usual (that is: duration by physician’s decision).
Sponsors
Utrecht University/ Utrecht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. First unprovoked VTE; 2. Legal age (>18 years).
Exclusion criteria
Exclusion criteria: 1. Treatment indication VKA of at least 1 year ie. recurrent VTE; atrial fibrillation; prosthetic valve; 2. Recent surgery with general or spinal anaesthesia, lower limb fracture with casting or active malignancy; 3. Pregnancy or puerperium; 4. Not willing or able to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent VTE during 24 months of follow-up after the initial 6 months of VKA treatment. VTE is defined as proximal DVT and/or fatal or non-fatal PE as confirmed by compression US for DVT and by (spiral CT) angiography and/or ventilation-perfusion lung scanning for PE. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The occurrence of major bleedings; 2. Quality of life (based on QoL questionnaires at T=12 and T=24 months); 3. Cost-effectiveness (at T=24 months using a Markov decision model). | — |
Contacts
Public ContactJ.M.T. Hendriksen
Universiteitsweg 100
Outcome results
None listed