Clinical Trial: The Ideal Deep Venous Thrombosis (DVT) Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health Related Quality of Life (HRQOL) [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
    HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated
  • Recurrent venous thrombosis [ Time Frame: 24 months ]
  • Mortality due to venous thrombosis [ Time Frame: 24 months ]
  • Costs [ Time Frame: 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
  • Patient Preferences [ Time Frame: baseline, 24 months ]
    Patient preferences will be elicited by conducting a discrete choice experiment (DCE)


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: August 24, 2011
Date Started: March 2011
Date Completion: July 2017
Last Updated: September 28, 2015
Last Verified: July 2015