In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve. This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs. ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up. This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
865
Individually tailored duration of elastic compression therapy,based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months
Elastic compression therapy with a standard duration of 24 months
Azienda Ospedaliera di Padova
Padua, Italy
Treviso Aziende
Treviso, Italy
Flevohospital
Almere Stad, Netherlands
VU Medical Centre
Amsterdam, Netherlands
Slotervaart hospital
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
AMC
Amsterdam, Netherlands
Maxima Medical Centre
Eindhoven, Netherlands
UMCG
Groningen, Netherlands
Atrium Medical Centre
Heerlen, Netherlands
...and 4 more locations
The occurrence of PTS at 24 months after the event of acute DVT
Time frame: At 24 months after the event of the acute DVT
Health Related Quality of Life (HRQOL)
HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated
Time frame: Baseline, 3, 6, 12 and 24 months
Recurrent venous thrombosis
Time frame: 24 months
Mortality due to venous thrombosis
Time frame: 24 months
Costs
Costs will include direct costs (e.g. medical therapy) and indirect costs (e.g. travel) and will be measured by case record forms, hospital data and 5 retrospective cost-questionnaires
Time frame: 3, 6, 12, 24 months
Patient Preferences
Patient preferences will be elicited by conducting a discrete choice experiment (DCE)
Time frame: baseline, 24 months
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