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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR
RECRUITING
Cascavel
Clínica Médica Longevittá
RECRUITING
Cuiabá
Hospital Erasto Gaertner
RECRUITING
Curitiba
Hospital Santa Casa de Curitiba
RECRUITING
Curitiba
NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa
RECRUITING
Curitiba
Sociedade Evangélica Beneficente de Curitiba
RECRUITING
Curitiba
Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go
RECRUITING
Goiânia
Flebocurso
RECRUITING
Londrina
Angio Vascular Hospital LTDA
RECRUITING
Natal
Centro: Serviço de Cirurgia Vascular HSLPUCRS
RECRUITING
Porto Alegre
Clínica vascular MDC Sociedade Simples ME
RECRUITING
Porto Alegre
Hospital dos Servidores do Estado do Pernambuco
RECRUITING
Recife
Instituto de Ensino e Treinamento em Saúde Vascular da Bahia
RECRUITING
Salvador
Clínica Dr. Alexandre Reis EIRELI
RECRUITING
Santos
CIP - Fundação Faculdade de Medicina de São José do Rio Preto
RECRUITING
São José Do Rio Preto
SAMAR Serviços Médicos
RECRUITING
São Paulo
Pró Saúde Clínica Médica
RECRUITING
Tubarão
Pró Circulação® - Clinic of Angiology and Vascular Surgery
RECRUITING
Xanxerê
Contact Information
Primary
Eduardo Matta, MD
procirculacao@gmail.com
55 (49) 3433-9050
Backup
Clodoaldo A De Sá, Ph.D.
55 (49) 3321-8215
Time Frame
Start Date: 2018-05-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 120
Treatments
Experimental: Compression arm
The compression arm will receive an adjustable velcro compression device for the calf (Circaid Juxtalite® Lower Leg; Medi Gmbh, Bayreuth, Germany), thigh and knee (Circaid Juxtafit; Medi Gmbh, Bayreuth, Germany). The Circaid device will be applied with an average pressure of more than 40 mmHg, verified through a BPS (built-in pressure system).
No_intervention: Control arm
No compression
Sponsors
Leads: Pró Circulação®

This content was sourced from clinicaltrials.gov

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