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

Pró Circulação®

Status: Enrolling

Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis

Treatments: Device: Circaid

Study type: Interventional

Funder types: Other

Identifiers

NCT03368313

Circaid

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Compression arm

Experimental group

Description:

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).

Treatment:

Device: Circaid

Control arm

No Intervention group

Description:

No compression