Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 18
- 主要终点
- Change in edema using perimetry (cm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in edema using perimetry (cm)
时间窗: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
The circumference will be measured at two different levels of the foot and at five distinct levels of the leg, using a normal tape measure. No pressure will be applied to these measures to avoid affecting their accuracy. The measurement of the first foot is made five centimeters proximal to the base of the first proximal phalanx of the second toe and the second measurement five centimeters proximal to the first measurement. The measurement of the first leg will be performed five centimeters above the lower edge of the lateral malleolus and then every five centimeters, reaching a total of six to eight measurements, depending on the height of the leg.
Change in pain level using visual analog scale
时间窗: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Pain level will be registered using a pain visual analog scale (VAS). The pain VAS ranges from 0 (no pain at all) to 10 (very severe pain) and is a self-reported scale where the patient is asked to mark his/her pain level on the line between the two endpoints. A higher score indicates a greater pain intensity.
次要结局
- Quality of life using VEINES-QOL/Sym questionnaire(Baseline visit and at one, six and 12 months of followup visits.)
- Postthrombotic syndrome (PTS) using Ginsberg's criteria(Baseline visit, after 15 days, one month, six months and 12 months of followup visits.)
- Quality of life using PROMIS Global-10(Baseline visit and at one, six and 12 months of followup visits.)
- Postthrombotic syndrome (PTS) using Villalta's scale(Baseline visit, after 15 days, one month, six months and 12 months of followup visits.)
- Physical activity using Global Physical Activity Questionnaire(Baseline visit and at one, six and 12 months of followup visits.)