Clinical trial NCT03368313: Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis
Official title: Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Post Thrombotic Syndrome
Keywords: Nonelastic compression theraphy
Compression theraphy
Compression stockings
Lead sponsor: Pró Circulação®
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain level using visual analog scale
timeFrame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
measure: Change in edema using perimetry (cm)
timeFrame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Secondary outcomes:
measure: Postthrombotic syndrome (PTS) using Ginsberg's criteria
timeFrame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
measure: Postthrombotic syndrome (PTS) using Villalta's scale
timeFrame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
measure: Quality of life using VEINES-QOL/Sym questionnaire
timeFrame: Baseline visit and at one, six and 12 months of followup visits.
measure: Quality of life using PROMIS Global-10
timeFrame: Baseline visit and at one, six and 12 months of followup visits.
measure: Physical activity using Global Physical Activity Questionnaire
timeFrame: Baseline visit and at one, six and 12 months of followup visits.
Other outcomes:
Locations:
city: Bahia
country: Brazil
facility: Instituto de Ensino e Treinamento em Saúde Vascular da Bahia
state: BA
city: Goiânia
country: Brazil
facility: Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go
state: GO
city: Cuiabá
country: Brazil
facility: Clínica Médica Longevittá
state: Mount
city: Recife
country: Brazil
facility: Hospital dos Servidores do Estado do Pernambuco
state: PE
city: Cascavel
country: Brazil
facility: Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR
state: PR
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: PR
city: Curitiba
country: Brazil
facility: Hospital Santa Casa de Curitiba
state: PR
city: Curitiba
country: Brazil
facility: NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa
state: PR
city: Curitiba
country: Brazil
facility: Sociedade Evangélica Beneficente de Curitiba
state: PR
city: Londrina
country: Brazil
facility: Flebocurso
state: PR
city: Natal
country: Brazil
facility: Angio Vascular Hospital LTDA
state: RN
city: Porto Alegre
country: Brazil
facility: Centro: Serviço de Cirurgia Vascular HSLPUCRS
state: RS
city: Porto Alegre
country: Brazil
facility: Clínica vascular MDC Sociedade Simples ME
state: RS
city: Tubarão
country: Brazil
facility: Pró Saúde Clínica Médica
state: SC
city: Xanxerê
country: Brazil
facility: Pró Circulação® - Clinic of Angiology and Vascular Surgery
state: SC
city: Santos
country: Brazil
facility: Clínica Dr. Alexandre Reis EIRELI
state: SP
city: São José Do Rio Preto
country: Brazil
facility: CIP - Fundação Faculdade de Medicina de São José do Rio Preto
state: SP
city: São Paulo
country: Brazil
facility: SAMAR Serviços Médicos
state: SP
Study officials:
affiliation: Pró Circulação®
name: Eduardo Matta, MD
role: PRINCIPAL_INVESTIGATOR
References: