Evaluation of Intermittent Pneumatic Compression (IPC) of the Lower Limbs Associated With Elastic Stockings (ES) Compared to ES Alone on Venous Thromboembolism Incidence in Patients With High Bleeding Risk Hospitalized in Intensive Medical Care Units
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 13
- 主要终点
- Combined criterion evaluated at day 6 ± 2 days after randomization:symptomatic venous thromboembolic event, non fatal, objectively confirmed,Death related to PE,Asymptomatic DVT of the lower limbs detected by CUS on day 6 ± 2 days.
研究概览
简要总结
This multicentre open-label randomized parallel-group trial aims to evaluate the association intermittent pneumatic compression + elastick stockings versus elasting stockings alone on symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day 6 (+/-2days), in patients hospitalized in intensive care units and with high bleeding risk.
详细描述
Background: Venous thromboembolism is a leading cause of morbi-mortality for patients hospitalized in intensive medical care units. Nevertheless, few studies evaluating prophylactic methods exist. Data from these studies demonstrate however that unfractionated heparin and low molecular weight heparin are effective to reduce the incident rate of asymptomatic deep venous thrombosis (DVT) of the lower limbs by 50 % compared to the absence of prophylaxis. Rate of asymptomatic DVT remains about 15 %. When the bleeding risk is high, drug prophylaxis with anticoagulants is contra-indicated, and mechanical devices are recommended: elastic stockings (ES) alone or associated with intermittent pneumatic compression (IPC). However, mechanical devices have not been systematically evaluated in intensive medical care units.
Objective:
To compare the association IPC + ES to ES alone in patients with high bleeding risk and hospitalized in intensive medical care units, on symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day 6.
Design: Multicentre open-label randomized parallel-group trial with blinded evaluation of outcomes, and an inclusion period of 24 month. Brest CIC (Centre d'Investigations Cliniques, research center) coordinates this multicentre trial.
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
- None
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
- •Age > 18 Years,
- •Admission in intensive medical care unit
- •High risk for hemorrhage
- •Written informed consent given by the patient or relative.
- •High risk for hemorrhage is defined by:
- •symptomatic bleeding or organic lesions likely to bleed,
- •hemophilic diseases,
- •haemostatic abnormalities: platelet count < 50 000/mm 3, APTT > 2 N, prothrombin time < 40%,
- •recent intra-cerebral hemorrhage,
- •severe anemia (Hemoglobin < 7 g/dl) due to a bleeding or unexplained.
排除标准
- •Age < 18 years,
- •Patient refusal,
- •No high risk for hemorrhage
- •Admission in intensive care unit ≥ 36 hours
- •Admission in intensive care unit likely for < 72 hours
- •A "do not resuscitate" order
- •IPC contra-indication: Recent DVT (< 3 month), severe lower limbs arteriopathy (III and IV), any arterial graft of the legs, a wound in the lower limb related either to a vascular disease (ulcer) or a trauma.
- •Patient with mechanical prosthetic heart valve.
结局指标
主要结局
Combined criterion evaluated at day 6 ± 2 days after randomization:symptomatic venous thromboembolic event, non fatal, objectively confirmed,Death related to PE,Asymptomatic DVT of the lower limbs detected by CUS on day 6 ± 2 days.
时间窗: 6 days (+/- 2 days)
次要结局
- Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality at 1 month and 3 months.(6 days to 3 months)