Overview

This trial is active, not recruiting.

Condition postthrombotic syndrome
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose prevention
Arm
(Experimental)
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.
individually tailored duration of elastic compression therapy Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
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
(Active Comparator)
Elastic compression therapy with a standard duration of 24 months
elastic compression therapy with a standard duration of 24 months Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
Elastic compression therapy with a standard duration of 24 months

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
Costs
time frame: 3, 6, 12, 24 months
Patient Preferences
time frame: baseline, 24 months

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.