NCT00699621Unknown不适用
Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT
研究概览
简要总结
- To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage.
- To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.
详细描述
- Hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage.
- Some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage.
- Immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole
- •acute primary ICH
- •> 17 years
- •admitted within 6 h after onset of ICH
- •ICH score < 4
排除标准
- •other type of ICH than acute primary intracerebral hemorrhage
- •patients who need neurosurgery
- •life expectancy less than 3 months due to comorbid disorders
- •confirmed malignant disease (cancer)
- •confirmed acute myocardial infarction
- •hepatitis and/liver cirrhosis
- •renal failure
- •infectious disease (HIV, endocarditis etc.)
- •current or previous hematologic disease
- •women of childbearing age if pregnant
- •participation in another study within the preceding 30 days
结局指标
主要结局
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT
时间窗: 24 hours
次要结局
- Glasgow Outcome Score(90 days)
- Cardiovascular death occurring within the treatment period(90 days)
- Death due to any cause occurring within the treatment period(90 days)
- Acute myocardial infarction(90 days)
- Venous thromboembolism(90 days)
研究者
研究点 (2)
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