A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Utility-weighted modified Rankin Scale (UW-mRS)
研究概览
简要总结
A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.
详细描述
Basal ganglion hemorrhage is one of the most common subtypes of cerebral hemorrhage, characterized by high morbidity, mortality, and disability rates. Minimally invasive surgery for cerebral hemorrhage, particularly utilizing a fiber tract-based AI Robot Guiding System, has shown potential advantages for patient prognosis. However, there is currently no standardized practice or robust evidence confirming the effectiveness and safety of this technology for small-volume basal ganglion hemorrhage. Therefore, we are conducting a nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion 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)
盲法说明
Patients will be randomly assigned to treatment or conservative group, so masking is only for outcome assessors
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at randomization
- •Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
- •Hematoma volume 15-30 mL (excluding 30 mL)
- •Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)
- •CT shows stable hematoma (≥6h interval, change <5 mL)
- •Surgery feasible within 72h after onset
- •Pre-ICH mRS ≤1
- •Informed consent obtained according to laws and ethics
排除标准
- •Hematoma involving the thalamus, midbrain, or other areas
- •Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage
- •Signs of impending brain herniation, such as midline shift >1 cm or changes in the ipsilateral pupil;
- •Any irreversible coagulopathy disorders or known coagulation system disease; platelet count <100,000; INR >1.4; use of anticoagulants within 7 days prior to this hemorrhage;
- •Pregnant or possibly pregnant
- •Patients with severe concomitant diseases that may interfere with outcome assessment
- •Poor compliance or follow-up difficulties
研究组 & 干预措施
Tract-based AI Robot Guiding System Group
Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System
干预措施: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System (Procedure)
Conservative Group
Patients will be managed with guideline-based medications without surgery
干预措施: Patients will be managed with guideline-based medications (Drug)
结局指标
主要结局
Utility-weighted modified Rankin Scale (UW-mRS)
时间窗: 6 months
The mRS is a 7-level ordinal scale used to evaluate functional outcomes after stroke. The categories are defined as follows: 0 = No symptoms； 1. = No significant disability. Able to carry out all usual activities, despite some symptoms； 2. = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities； 3. = Moderate disability. Requires some help, but able to walk unassisted； 4. = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted； 5. = Severe disability. Requires constant nursing care and attention, bedridden, incontinent； 6. = Dead； Utility-weighted modified Rankin Scale (UW-mRS), which applies utility values to each mRS category as shown below： mRS 0= UW-mRS 1；mRS 1= UW-mRS 0.91; mRS 2= UW-mRS 0.76; mRS 3= UW-mRS 0.65; mRS 4= UW-mRS 0.33; mRS 5= UW-mRS 0; mRS 6= UW-mRS 0.
次要结局
- Ordinal shift in modified Rankin Scale(6 months)
- Excellent functional neurological outcome(6 months)
- Independent functional neurological outcome(6 months)
- Health Related Quality of Life(6 months)
- AD8 Dementia Screening(6 months)
- Total length of hospital stay(6 months)
- Hematoma evacuation rate(30 days after treatment)
- Total medical expenses during hospitalization(6 month)