Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage: a Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- The proportion of patients with Modified Rankin Scale (mRS) score 0-3
研究概览
简要总结
This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.
详细描述
Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hematoma evacuation rates, and improves postoperative outcomes, including neurological recovery, activities of daily living, and quality of life in patients with large cerebral hemorrhage. However, there is a paucity of prospective randomized controlled trials evaluating the efficacy of different surgical techniques for intracerebral hemorrhage. To address this gap, the investigators propose a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of neuroendoscopic surgery versus craniotomy, aiming to provide evidence-based guidance for surgical decision-making in cerebral hemorrhage management.
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
- •Age 18-80 years old, male or female;
- •The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used);
- •Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil);
- •Before randomization, GCS score was 5-14, NIHSS score was ≥6;
- •mRS Before onset: 0-1 score;
- •Randomization within 24 hours after the first diagnostic CT;
- •The patient or family members are informed and voluntarily sign the informed consent;
排除标准
- •The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;
- •Thalamic hemorrhage, primary ventricular hemorrhage;
- •Platelet count <100×109/L, INR > 1.4;
- •Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;
- •Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points;
- •Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days;
- •Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required;
- •Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems;
- •Pregnant or breastfeeding women, or those who expect to become pregnant within one year;
- •are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).
研究组 & 干预措施
Experimental Arm
Neuroendoscopic Surgery to remove intracranial hematoma
干预措施: neuroendoscopic surgery (Procedure)
Control Arm
Craniotomy to remove intracranial hematoma
干预措施: craniotomy (Procedure)
结局指标
主要结局
The proportion of patients with Modified Rankin Scale (mRS) score 0-3
时间窗: 180 days
Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.
次要结局
- Length of hospitalization(Number of days from admission to discharge, up to 180 days)
- Modified Rankin Scale (mRS) Score(180 days)
- mortality(30 days, 90 days and 180 days)
- Glasgow Outcome Scale Extended (GOS-E)(180 days)
- Assessment of cognitive function with Mini-Mental State Examination (MMSE)(90 days and 180 days)
- Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)(30 days and 180 days)
- The proportion of patients with Modified Rankin Scale (mRS) score 0-2(180 days)
- Length of ICU(Number of days from admission, up to 180 days)
- The proportion of patients with Modified Rankin Scale (mRS) score 0-3(30 days and 90 days)
- Operation duration(From the beginning to the end of the surgery)
- Peroperative bleeding(During surgery)
研究者
Rong Hu, MD
Director of Department of Neurosurgery
Southwest Hospital, China