Evaluation of the Efficacy of Elastic Compression in Preventing Post-thrombotic Syndrome. Randomised Non-inferiority Study for Ankle Pressure Targeted at 25 mm Hg Versus 35 mm Hg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 57
- 主要终点
- To show that elastic compression with ankle pressure targeted at 25 mm Hg is not inferior in preventing the onset of clinical post-thrombotic syndrome to a target ankle pressure of 35 mm Hg (recommended pressure being greater than 30 mm Hg)
研究概览
简要总结
Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying 30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS may be difficult to apply and to wear.
ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance.
CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle
详细描述
CELEST trial is a controlled, randomized, multicentre, non-inferiority double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle. Patients with a first acute symptomatic proximal DVT will be randomized to wear for two years either ECS applying 25mmHg of targeted pressure at the ankle or ECS applying 35mmHg of targeted pressure at the ankle. All patients will be prescribed anticoagulants for at least three months. The primary outcome will be the rate of PTS assessed with the Villalta scale in both arms of the study during the 2 years study period. Rate of compliance,severity of PTS and quality of life in both groups will constitute the main secondary outcomes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (male/female) at least 18 years old
- •Patient presenting with an initial episode of proximal deep vein thrombosis (DVT) confirmed by an additional examination (echo-Doppler scan) taken no more than 8 days previously :
- •the proximal character defined by a DVT from the collecting trunk extending from the tibial-peroneal trunk to the inferior vena cava inclusive the unilateral character concerns only the proximal part. Patients with a distal DVT on the contralateral member the day of diagnosis can be included The notion of initial episode concerns only the proximal part. Patients with a preceding DVT limited to distal part can be included
- •with no trophic disorders at baseline (CEAP class 4, 5 or 6 excluded)
- •with or without pulmonary embolism
- •Patient capable of benefiting from anticoagulant therapy of at least 3 months duration
- •Available to participate in a clinical trial with a 24-month follow-up period and for which a delivery of study products may be possible throughout its participation (delivery possible only in Metropolitan France)
- •Life expectancy greater than 24 months
- •Volunteer to take part in the study, having signed the consent form after receiving sufficient information and the information leaflet
- •Person affiliated to social security or the recipient of a similar scheme.
- •non inclusion criteria
- •Patients with at least one of these contraindications to compression treatment:
- •phlegmasia cerulea dolens,
- •septic thrombosis,
- •product intolerance, allergic reaction to one of the components
- •Arteritis obliterans stage III and IV of the lower limbs (IPS<0.6),
- •Micro-angiopathy, advanced diabetes,
- •Decompensated heart failure,
- •Skin infections: anti-infective treatment must precede compression therapy,
- •Weeping skin diseases of the leg.
- •Compression treatment technically impossible during the study
- •Patients presenting with bilateral venous thrombosis of the lower limbs.
- •Patient having received fibrinolytic treatment, mechanical thrombo-aspiration or venous repermeation surgery for venous thrombosis justifying inclusion
- •Patients having undergone mechanical interruption of the inferior vena cava.
- •Patients for whom long-term elastic compression for the treatment of lymphatic venous insufficiency (patients with lymphoedema), for instance, is indicated prior to DVT. Patients with elastic compression for primary thromboprophylaxis of thromboembolic disease (TED) are eligible.
- •Patients presenting with oedema unrelated to venous insufficiency or in whom oedema is likely to develop within 2 years.
- •Patients receiving diuretic treatment for more than 3 months due to heart failure.
- •Pregnant women
- •Person deprived of liberty by a legal or administrative decision, person under legal protection.
- •Patient currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
- •Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol
排除标准
- 未提供
研究组 & 干预措施
25mmHg ECS
Thigh-length graduated elastic compression stockings applying 25mmhg of targeted pressure at the ankle worn daily for two years
干预措施: 25mmHg ECS (Device)
35mmHg ECS
Thigh-length graduated elastic compression stockings applying 35 mmhg of targeted pressure at the ankle worn daily for two years
干预措施: 35 mmHg ECS (Device)
结局指标
主要结局
To show that elastic compression with ankle pressure targeted at 25 mm Hg is not inferior in preventing the onset of clinical post-thrombotic syndrome to a target ankle pressure of 35 mm Hg (recommended pressure being greater than 30 mm Hg)
时间窗: 24 months
cumulative incidence 24 months after inclusion of PTS apparition defined by the Villalta score \> or equal to 5. A visual guide will be given to investigators to assist them and standardize PTS evaluation. Investigators will receive a Villalta training during set up visits.
次要结局
- Adverse events(24 months)
- Superiority of 25 mm Hg on the therapeutic compliance criterion(24 months)
- non inferiority of 25 mm Hg for the onset of permanent trophic disorders(3 months, 12 and 24 months)
- test for key factors in good compliance(24 months)
- superiority of targeted pressure at 35 mm Hg for compliant patients. Analysis of the primary endpoint per protocol amongst patients responding to the definition of compliance for compression scheduled by randomization(24 months)
- non inferiority of 25 mm Hg for the intensity of long term chronic venous insufficiency symptoms (12 months and 24 months)(12 and 24 months)
- non inferiority of 25 mm Hg for the onset of sequalae or post thrombotic residues on an duplex scan at 3 months, 12 and 24 months(3, 12 and 24 months)
- Subgroups analysis of the primary objective and secondary objectives according to the gender stratification criterion and age(24 months)
- superiority of 25 mmHg on 35 mmHg in preventing the onset of clinical post thrombotic syndrome(24 months)
- Non-inferiority of 25 mm Hg for changes in overall quality of life evaluated on the basis of the EUROQUOL questionnaire(3months, 12 months, 24 months)
- testing for the prognostic factors of the onset post thrombotic syndrome and comparison of the onset kinetics of post thrombotic syndrome(24 months)
- superiority of 25 mm Hg for constraints related to compression and chronic venous insufficiency quality of life (CIVIQ)(3 months, 12 months, 24 months)
- non inferiority of 25 mm Hg for the comparative evaluation of the symptomatic effect of short-term compression (pain, sensation of oedema) form baseline to 3 months(3 months)
- sensitivity analysis of primary endpoint excluding patients with a differential diagnosis can explain a Villalta score ≥ 5(24 months)