A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mortality and disability
研究概览
简要总结
Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.
详细描述
Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a spontaneous lobar and basal ganglia ICH on CT scan
- •Patient within 72 hours of ictus
- •Best score on the GCS of 5-
- •Volume of hematoma between 30 and 100ml [Calculated using (a x b x c)/2 method]
- •The history of hypertensive
排除标准
- •Clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
- •Intraventricular hemorrhage of any sort
- •ICH secondary to tumour or trauma.
- •If the hematological effects of any previous anticoagulants are not completely reversed.
结局指标
主要结局
Mortality and disability
时间窗: 3 months
according to a 3-6 scores on the modified Rankin Score
次要结局
- Occurrence of second Surgery(72 hours)
研究者
Rong Hu
Associate Professor
Southwest Hospital, China