The Ideal Deep Venous Thrombosis (DVT) Study
- Conditions
- Postthrombotic Syndrome
- Interventions
- Device: Individually tailored duration of elastic compression therapyDevice: Elastic compression therapy with a standard duration of 24 months
- Registration Number
- NCT01429714
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 865
- Legal age (18 yrs)
- Informed consent
- Acute objectively documented DVT of the leg
- Adequate anticoagulation
- Previous DVT in the affected leg
- Recurrent DVT in the first 6 months following inclusion
- Preexistent venous insufficiency (skin signs C4-C6 on CEAP score or requiring ECS therapy)
- Contraindication for elastic compression therapy (arterial insufficiency)
- Active thrombolysis
- Life expectancy < 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention: individually tailored ECS Individually tailored duration of elastic compression therapy 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. Control: ECS 24 months Elastic compression therapy with a standard duration of 24 months Elastic compression therapy with a standard duration of 24 months
- Primary Outcome Measures
Name Time Method The occurrence of PTS at 24 months after the event of acute DVT At 24 months after the event of the acute DVT
- Secondary Outcome Measures
Name Time Method Patient Preferences baseline, 24 months Patient preferences will be elicited by conducting a discrete choice experiment (DCE)
Mortality due to venous thrombosis 24 months Costs 3, 6, 12, 24 months 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
Health Related Quality of Life (HRQOL) Baseline, 3, 6, 12 and 24 months HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated
Recurrent venous thrombosis 24 months
Trial Locations
- Locations (14)
Azienda Ospedaliera di Padova
๐ฎ๐นPadua, Italy
UMC Nijmegen Radboud
๐ณ๐ฑNijmegen, Netherlands
Treviso Aziende
๐ฎ๐นTreviso, Italy
UMCG
๐ณ๐ฑGroningen, Netherlands
OLVG
๐ณ๐ฑAmsterdam, Netherlands
Maxima Medical Centre
๐ณ๐ฑEindhoven, Netherlands
VU Medical Centre
๐ณ๐ฑAmsterdam, Netherlands
Atrium Medical Centre
๐ณ๐ฑHeerlen, Netherlands
Westfriesgasthuis
๐ณ๐ฑHoorn, Netherlands
Laurentius ziekenhuis
๐ณ๐ฑRoermond, Netherlands
Flevohospital
๐ณ๐ฑAlmere, Netherlands
Slotervaart hospital
๐ณ๐ฑAmsterdam, Netherlands
Maastricht University Medical Centre
๐ณ๐ฑMaastricht, Netherlands
AMC
๐ณ๐ฑAmsterdam, Netherlands