Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Functional recovery according to UW-mRS assessed at 6 months
研究概览
简要总结
The objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified Rankin Scale (UW-mRS) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ICH) of 20 ≤ volume ≤ 30 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 20 ≤ volume ≤ 30 ml;
- •Reduced level of consciousness (GCS 9-14);
- •Pre-stroke mRS score≤1 points;
- •Systolic blood pressure <140 mmHg before randomisation;
- •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
Functional recovery according to UW-mRS assessed at 6 months
时间窗: 6 months
Utility weighted modified rankin scale scores is to map functional status (modified Rankin Scale \[mRS\] scores) and health-related quality of life on the European Quality of Life 5-dimensional questionnaire (EQ-5D) to derive utility-weighted (UW) stroke outcome measures.
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
President, Head of Neurology, Principal Investigator, Clinical Professor, Xuanwu Hospital of Capital Medical University
Capital Medical University