Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- The primary outcome is death or major disability (mRS scores 0-3) at 6 months.
研究概览
简要总结
To determine if minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared with any other neurosurgical technique that includes open craniotomy, small skull window microsurgery , and endoscopic surgery, is at least as effective ('not inferior') on poor clinical outcome of death or major disability (mRS scores 4-6) at 6 months in basal ganglia intracerebral hemorrhage (ICH) of 30 < volume ≤ 100 ml.
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
- •Inclusion Criteria:
- •Adults (18 - 80 years) ;
- •The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
- •Onset within 48 hours, and surgery can be initiated within 48 hours;
- •Basal ganglia hemorrhage, with a bleeding volume of 30 < volume ≤ 100 ml;
- •Reduced level of consciousness (GCS 4-14);
- •Pre-stroke mRS score≤1 points;
- •Systolic blood pressure <140 mmHg before randomisation;
- •Availability of being able to receive either scMIS or other neurosurgical technique;
- •Informed consent obtain accordingly to local regulations.
排除标准
- •Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery.
- •A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
- •Platelet count < 100,000, INR > 1.4.
结局指标
主要结局
The primary outcome is death or major disability (mRS scores 0-3) at 6 months.
时间窗: 6 months after randomization
Ordinal analysis of modified Rankin Scale \[mRS\] score: 0 =No symptoms at all.1 =No significant disability despite symptoms, able to carry out all usual duties and activities.2 =Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance.3 =Moderate disability requiring some help, but able to walk without Assistance. 4 =Moderate severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance.5 =Severe disability, bedridden incontinent, and requiring constant nursing care and attention.6 =Dead.
次要结局
- Discharge at Day 7 (yes vs. no)(7 days after randomization)
- Total length of intensive care unit stay(During hospitalisation up to 6 months after randomization)
- Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days(28 days after randomization)
- The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6(6-months after randomization)
- The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5(6-months after randomization)
- The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6(6-months after randomization)
- The following at 6-months: AMC Linear Disability Score(ALDs)(6-months after randomization)
- The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)(6-months after randomization)
- Days of hospitalization(During hospitalisation up to 6 months after randomization)
研究者
Ji Xunming,MD,PhD
Professor ,Beijing Institute of Brain Disorders,Captial Medcial University
Capital Medical University