NCT01429714

The Ideal Deep Venous Thrombosis (DVT) Study

Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 865 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postthrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	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
DEVICE	Elastic compression therapy with a standard duration of 24 months	Elastic compression therapy with a standard duration of 24 months

Timeline

• Start date: 2011-03-22
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2011-09-07
• Last updated: 2018-04-10

Locations

14 sites across 2 countries: Italy, Netherlands