PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism
研究概览
简要总结
Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism. Intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ICH because the use of anticoagulants may cause an enlargement of the hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Intracranial spontaneous hemorrhage on brain CT scan
- •Intracranial hemorrhage during treatment with oral anticoagulants
- •Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage).
排除标准
- •cerebral hemorrhage due to intracranial vascular malformation
- •rebleeding on CT scan after 72 hours from stroke (before randomization)
研究组 & 干预措施
low weight molecular heparin
enoxaparin 0.4 ml subcutaneous per day
干预措施: Enoxaparin (Drug)
standard therapy
Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization
干预措施: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization (Other)
结局指标
主要结局
Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism
时间窗: 10 days
Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination
次要结局
- Bleedings(90 days)
- Mortality(90 days)
- Disability(90 days)
研究者
Maurizio Paciaroni
Principal Investigator
University Of Perugia