'Venous thromboembolism' 'thrombosis'
Conditions
Interventions
Individual estimation of risks and benefits of continuation of treatment based
on the VTE-BLEED and L-TRRiP model
and treatment decision based on these
risks. Discontinuation of anticoagulation for those with a low risk of
recurrent thrombosis, continuation of anticoagulation for those with a high
risk of recc
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Be diagnosed with a first confirmed symptomatic deep vein thrombosis (including distal vein thrombosis, in Dutch ' kuitvenetrombose') or pulmonary embolism with an indication for treatment with anticoagulant therapy for at least 3 months as prescribed by their treating physician. 3. Be aged 18 years or above.
Exclusion criteria
Exclusion criteria: 1. Patients with active cancer (i.e. cancer diagnosis within six months before VTE (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before the venous thromboembolism was diagnosed) or antiphospholipid syndrome 2. Patients who need to continue anticoagulant treatment for another indication (e.g. atrial fibrillation). 3. Patients with a strong indication for long-term antiplatelet therapy despite oral anticoagulation (e.g. those with recent STEMI) 4. Patients with COVID-19 associated VTE (i.e. hospital admission because of COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the combination of recurrent VTE and major bleeding events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are 1) the combined endpoint (recurrent VTE and major bleeding) with both events weighted by the associated quality-adjusted life year (QALY) loss and 2) cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactR.Y. Kok
Leids Universitair Medisch Centrum
Outcome results
None listed