NCT00699465Unknown4 期
A Double-blind Randomized Trial to Compare the Efficacy of Intermittent Pneumatic Compression (IPC) With and Without Early Anticoagulant Treatment for Prevention of Venous Thromboembolism (VTE) in Patients With Acute Primary Intracerebral Hemorrhage (ICH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The cumulative occurrence of confirmed VTE, defined as the composite of symptomatic or asymptomatic DVT, or symptomatic or fatal PE occurring during the treatment period.
研究概览
简要总结
- To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE.
- To assess the safety and efficacy of additional therapy with enoxaparin.
- To compare the efficacy and safety of the European and American guideline recommendations.
- To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.
详细描述
- Although it has been poorly investigated, the risk of VTE among patients with acute primary intracerebral hemorrhage is generally believed to be at least as high as among patients with ischemic stroke.
- The currently available guidelines state that while low doses of subcutaneous heparin or low-molecular-weight heparin may reduce VTE, it is possible that their effect is counterbalanced by an increase in hemorrhagic complications.
- It is still unclear when (if ever) low-molecular-weight-heparin should be safely initiated in ICH patients.
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
- 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
- •acute primary ICH
- •> 17 years
- •unable to walk
- •admitted within 12 h after onset of ICH
- •informed consent obtained
排除标准
- •other type of ICH than acute primary intracerebral hemorrhage
- •patients who need neurosurgery
- •evidence of VTE at screening
- •thrombolytic treatment within the preceding week
- •major surgery or major trauma within the preceding 3 months
- •life expectancy less than 3 months due to comorbid disorders
- •confirmed malignant disease (cancer)
- •hepatitis and/or liver cirrhosis
- •renal failure
- •infectious disease (HIV, endocarditis etc.)
- •current of previous hematologic disease
- •recent active and untreated gastric/duodenal ulcer
- •allergy or known hypersensitivity to enoxaparin or heparins
- •known hypersensitivity to benzyl alcohol
- •women of childbearing age if pregnant
- •participation in another study within the preceding 30 days
研究组 & 干预措施
1
Active Comparator
Early enoxaparin
干预措施: enoxaparin (Drug)
2
Placebo Comparator
Late enoxaparin
干预措施: enoxaparin placebo (Drug)
结局指标
主要结局
The cumulative occurrence of confirmed VTE, defined as the composite of symptomatic or asymptomatic DVT, or symptomatic or fatal PE occurring during the treatment period.
时间窗: 90 days
次要结局
- Cardiovascular death occurring within the treatment period(90 days)
- Bleeding complications including rebleedings occurring within the treatment period(90 days)
- Increase in ICH volume observed by head CT or at autopsy during the treatment period(90 days)
- Death due to any cause occurring within the treatment period(90 days)
研究者
研究点 (1)
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