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RESEARCH QUESTION

Patients with a first VTE have a high risk of recurrence. Anticoagulant therapy is effective for prevention but not suitable for all patients due to its bleeding risk. Currently, many patients are over- or undertreated for a prolonged period. We aim to determine which patients, individually classified for VTE ánd bleeding risk, will benefit from this treatment without being unnecessarily

exposed to its risks.

 

HYPOTHESIS

If patients are individually classified with respect to VTE ánd bleeding risk, anticoagulant treatment will be optimized, leading to minimisation of thrombotic and bleeding events.

 

STUDY DESIGN

A registry based randomized controlled open blinded endpoint trial.

 

STUDY POPULATION

Patients without cancer, treated with anticoagulants for a first VTE who are about to complete this treatment.

 

INTERVENTION

Individual estimation of risks and benefits of treatment by using a web- or mobile device-based app. Randomisation to anticoagulation in a subgroup of 38% of patients.

 

OUTCOME MEASURES

The primary outcome will be the combination of recurrent VTE and major bleeding events. Secondary outcomes are 1) the combined endpoint with both events weighted by the associated quality-adjusted life year (QALY) loss and 2) cost-effectiveness.

 

SAMPLE SIZE/DATA-ANALYSIS

We expect to demonstrate significantly less clinical events in the group randomized to indefinite anticoagulation. For this we need a sample size of 276 per arm. As this group will form 38% of the total population, we need 1450 subjects in the complete study (rounded to 1600 for a drop-out of 10%).

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