Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial

  • STATUS
    Recruiting
  • End date
    Nov 30, 2025
  • participants needed
    120
  • sponsor
    Pró Circulação®
Updated on 15 October 2022
clot
deep vein thrombosis
venous thrombosis
acute deep venous thrombosis
deep venous thrombosis of lower extremity
post thrombotic syndrome
dvts
leg swelling

Summary

The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. With a hypothesis that the Circaid group will present a quicker and more marked reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in the frequency of postthrombotic syndrome within six months from the time of diagnosis of the acute deep vein thrombosis episode.

Description

The pain-relief and edema reduction associated with compressive therapy in patients with acute deep vein thrombosis (DVT) have been poorly documented in randomized controlled trials (RCTs). Compressive therapy is controversial in that it is currently unclear whether or not it might reduce the risk of postthrombotic syndrome (PTS), a chronic disorder identified in 25-50% of patients with a previous diagnosis of deep venous thrombosis. With the recent SOX trial deeming elastic compression stockings to be ineffective in preventing postthrombotic syndrome and with criticisms focused on the difficulty concerning patients' compliance with these devices, alternative methods such as non-elastic compression garments have been considered. Unfortunately, to our knowledge, no trials have investigated these devices applied with a greater pressure than compression stockings in the context of preventing pain and swelling in the acute DVT phase and of late complications (postthrombotic syndrome).

The experimental literature evaluating non-elastic compression garments is primarily focused on venous insufficiency rather than deep vein thrombosis. For example, previous randomized trial patients allocated to non-elastic compression garments presented faster healing rates/week for venous leg ulcers than a group receiving four-layered compression garments. Although this evidence is related to venous insufficiency, there are currently no RCTs exploring the effect of non-elastic compression in preventing postthrombotic syndrome.

Given this gap in the literature, study aimed at conducting a Bayesian randomized trial to assess a non-elastic compression garment (Circaid) versus a control group in patients with acute DVT.

Details
Condition Deep Vein Thrombosis, Post Thrombotic Syndrome
Treatment Circaid
Clinical Study IdentifierNCT03368313
SponsorPró Circulação®
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-80 years
Outpatients with acute deep venous thrombosis of lower extremity
Symptomatic patients
Involving femoro-popliteal and / or ilofemoral segment
Symptoms less than two weeks
Provoked or unprovoked TVP

Exclusion Criteria

History of TVP
Any allergy to the use of compression material
Severe arterial occlusive disease
Patients in whom thrombus removal is planned
Ankle index <0.5
Inability to walk
A life expectancy of less than six months
Geographic inaccessibility that prevents adequate follow-up with or without assistance
Thrombolytic therapy outside of this study for the initial treatment of acute DVT
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