The Ideal Deep Venous Thrombosis (DVT) Study

Study Overview
=================
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.

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

Conditions
-----------------
Postthrombotic Syndrome

Intervention / Treatment
-----------------
* Device: Individually tailored duration of elastic compression therapy
* Device: Elastic compression therapy with a standard duration of 24 months


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: individually tailored ECS<br>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: Individually tailored duration of elastic compression therapy<br>* 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<br>* Other names: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg);|
| Active Comparator: Control: ECS 24 months<br>Elastic compression therapy with a standard duration of 24 months | Device: Elastic compression therapy with a standard duration of 24 months<br>* Elastic compression therapy with a standard duration of 24 months<br>* Other names: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elastic Compression Stockings, Deep Venous Thrombosis, Post Thrombotic Syndrome