The Ideal Deep Venous Thrombosis (DVT) Study (IDEAL)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Postthrombotic Syndrome

Treatments: Device: Elastic compression therapy with a standard duration of 24 months; Device: Individually tailored duration of elastic compression therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01429714

10-2-026

80-82310-97-11017 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 865 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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865 participants in 2 patient groups

Intervention: individually tailored ECS

Experimental group

Description:

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.

Treatment:

Device: Individually tailored duration of elastic compression therapy

Control: ECS 24 months

Active Comparator group

Description:

Elastic compression therapy with a standard duration of 24 months

Treatment:

Device: Elastic compression therapy with a standard duration of 24 months