Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis

Last updated: September 27, 2022
Sponsor: Pró Circulação®
Overall Status: Active - Recruiting

Phase

N/A

Condition

Deep Vein Thrombosis

Blood Clots

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT03368313
Circaid
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 120
Study Start date:
May 01, 2018
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Instituto de Ensino e Treinamento em Saúde Vascular da Bahia

    Bahia, BA
    Brazil

    Active - Recruiting

  • Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go

    Goiânia, GO
    Brazil

    Active - Recruiting

  • Clínica Médica Longevittá

    Cuiabá, Mount
    Brazil

    Active - Recruiting

  • Hospital dos Servidores do Estado do Pernambuco

    Recife, PE
    Brazil

    Active - Recruiting

  • Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR

    Cascavel, PR
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, PR
    Brazil

    Active - Recruiting

  • Hospital Santa Casa de Curitiba

    Curitiba, PR
    Brazil

    Active - Recruiting

  • NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa

    Curitiba, PR
    Brazil

    Active - Recruiting

  • Sociedade Evangélica Beneficente de Curitiba

    Curitiba, PR
    Brazil

    Active - Recruiting

  • Flebocurso

    Londrina, PR
    Brazil

    Active - Recruiting

  • Angio Vascular Hospital LTDA

    Natal, RN
    Brazil

    Active - Recruiting

  • Centro: Serviço de Cirurgia Vascular HSLPUCRS

    Porto Alegre, RS
    Brazil

    Active - Recruiting

  • Clínica vascular MDC Sociedade Simples ME

    Porto Alegre, RS
    Brazil

    Active - Recruiting

  • Pró Saúde Clínica Médica

    Tubarão, SC
    Brazil

    Active - Recruiting

  • Pró Circulação® - Clinic of Angiology and Vascular Surgery

    Xanxerê, SC
    Brazil

    Active - Recruiting

  • Clínica Dr. Alexandre Reis EIRELI

    Santos, SP
    Brazil

    Active - Recruiting

  • CIP - Fundação Faculdade de Medicina de São José do Rio Preto

    São José Do Rio Preto, SP
    Brazil

    Active - Recruiting

  • SAMAR Serviços Médicos

    São Paulo, SP
    Brazil

    Active - Recruiting

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