Deep Venous Thrombosis Pulmonary Embolism
Conditions
Interventions
Patients randomized to the index group, undergo a prediction model guided
long-term treatment (see flow chart and study design). After six months of
initial VKA therapy, a prediction model is applie
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study population consists of consecutive patients with an unprovoked (idiopathic) VTE of the lower extremities or lungs who are referred to the Thrombosis Services for treatment with vitamin K antagonists. All patients have to be 18 years of age or older when inclusion takes place.
Exclusion criteria
Exclusion criteria: Patients with an initial indication for longer treatment with VKA (1 year or longer) * such as patients with recurrent VTE within 10 years, other indications like Atrial Fibrillation or Prosthetic heart valve. Ongoing malignancy (last treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint The primary outcome is the occurrence (incidence) of recurrent VTE during 24 months of follow-up after the initial 6 months of VKA treatment. Recurrent VTE is defined as proximal DVT and/or fatal or non-fatal PE as confirmed by compression ultrasonography for DVT and by (spiral CT) angiography and/or ventilation-perfusion lung scanning for PE. To prevent bias, interpretation of the compression ultrasonography as well as ventilation-perfusion lung scanning and/or (spiral CT) angiography will be blinded to allocated treatment strategy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints: Safety and secondary outcomes are the occurrence of major bleedings, quality of life and cost-effectiveness. A major bleeding is defined by retroperitoneal or intracranial bleeding, a bleeding with lowering of haemoglobin levels of at least 2.0 g/dl, or a bleeding for which transfusion is needed of at least 2 units blood or surgical intervention or invasive procedures to stop the bleeding. An independent and blinded adjudication committee will adjudicate each suspected thrombo-embolic recurrent event and death, as well as each potential bleeding event. A cost-effectiveness analysis will be performed from the societal perspective. With a Markov type decision model, costs and health effects as a consequence of difference of treatment are balanced against *care as usual*. Differences in costs result from different duration of treatment with VKA, from additional D-dimer tests, from treatment of recurrence of VTE and bleeding complications, and from productivity losses associated with recurrent events and bleeding complications. The time horizon used for the economic evaluation will be equal to the study period, i.e. a follow-up period of 24 months after an initial 6 months of VKA treatment. Quality of Life will be assessed at baseline, moment of intervention and during the follow-up period of 24 months, using both generic questionnaires (SF-36; EQ5D) and questions on health care consumption. | — |
Countries
Netherlands
Outcome results
None listed