The Ideal Deep Venous Thrombosis (DVT) Study
This trial is active, not recruiting.
|Treatments||individually tailored duration of elastic compression therapy, elastic compression therapy with a standard duration of 24 months|
|Sponsor||Maastricht University Medical Center|
|Collaborator||ZonMw: The Netherlands Organisation for Health Research and Development|
|Start date||March 2011|
|End date||July 2017|
|Trial size||847 participants|
|Trial identifier||NCT01429714, 10-2-026, 80-82310-97-11017|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Padua, Italy||Azienda Ospedaliera di Padova||no longer recruiting|
|Treviso, Italy||Treviso Aziende||no longer recruiting|
|Almere, Netherlands||Flevohospital||no longer recruiting|
|Amsterdam, Netherlands||AMC||no longer recruiting|
|Amsterdam, Netherlands||OLVG||no longer recruiting|
|Amsterdam, Netherlands||Slotervaart hospital||no longer recruiting|
|Amsterdam, Netherlands||VU Medical Centre||no longer recruiting|
|Eindhoven, Netherlands||Maxima Medical Centre||no longer recruiting|
|Groningen, Netherlands||UMCG||no longer recruiting|
|Heerlen, Netherlands||Atrium Medical Centre||no longer recruiting|
|Hoorn, Netherlands||Westfriesgasthuis||no longer recruiting|
|Maastricht, Netherlands||Maastricht University Medical Centre||no longer recruiting|
|Nijmegen, Netherlands||UMC Nijmegen Radboud||no longer recruiting|
|Roermond, Netherlands||Laurentius ziekenhuis||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (caregiver)|
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)
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
time frame: 3, 6, 12, 24 months
time frame: baseline, 24 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Legal age (18 yrs) - Informed consent - Acute objectively documented DVT of the leg - Adequate anticoagulation Exclusion Criteria: - 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
|Official title||Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial|
|Principal investigator||Arina J ten Cate-Hoek, MD, PhD, MpH|
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