Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 733
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. Two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. However, prospective and controlled studies are still lacking. This is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.
详细描述
Hypertensive intracerebral hemorrhage (HICH) is the most common hemorrhagic stroke. The morbidity and mortality exceed 60% and only 12% patients could live independently. The choice of surgical or conservative treatment for patients with HICH is controversial.
Some minimally invasive neurosurgeries have been applied to hematoma evacuation and may improve prognosis to some extent. In endoscopic evacuation, a small burr hole is created and hematoma is removed through suction and irrigation under neuroendoscope. Endoscopic surgical evacuation promise to maximize hematoma evacuation while minimizing damage to normal tissue. Stereotactic aspiration uses image guidance to place a catheter into the main body of the hematoma and aspirate blood. It is estimated that 720 patients (240 patients in each treatment group) would provide 90% power and a type I error probability of .05 to detect an effect size of 13% with a 10% dropout rate taken into consideration. Patients will receive endoscopic evacuation, stereotactic aspiration or craniotomy according to the results of randomization. Patients will be followed up at 7 days, 30 days and 6 months.
Outcomes of different groups of patients will be collected and compared. The study is designed to find a best surgical method for hypertensive intracerebral hemorrhage.
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
- Single (Outcomes Assessor)
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
- •Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL
- •Adult patients with GCS score ≥5
- •Admitted within 24h of ictus
排除标准
- •Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation
- •Concurrent head injury or history of head injury
- •Multiple intracerebral hemorrhage
- •Known advanced demential or disability before
- •With indications of terminal brain hernia
- •Severe concomitant diseases that affect life expectancy
- •Patients having taken anti-platelet or anticoagulant drugs for a long time
- •With severe intraventricular hemorrhage
- •Pregnant women
结局指标
主要结局
Modified Rankin Scale
时间窗: 6 months
The degree of disability or dependence in the daily activities. The scale runs from 0-6, running from perfect health without symptoms to death.
次要结局
- Hospitalization expenses(6 months)
- Operation Time(24 hours)
- Intraoperative Blood Loss(24 hours)
- Intracranial Infection Rate(7 days)
- Hematoma Clearance Rate(24 hours and 3 days)
- Barthel Index(6 months)
- Postoperative Glasgow Coma Scale(7 days)
- Rebleeding Rate(3 days)
- Days of ICU Stay(14 days)
- Mortality(30 days)
研究者
Xiaolei Chen
Professor
Chinese PLA General Hospital