A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Modified Rankin Scale (mRS) score at 6 months
Study Overview
Brief Summary
This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.
Detailed Description
This substudy adopts an open-label design, while outcome assessment is performed in a blinded manner. The primary outcome is the modified Rankin Scale (mRS) at 6 months. Outcomes at 30 days, 90 days, and 6 months will also be assessed. Follow-up will be conducted at baseline; 24 hours after surgery/ 30 hours after randomization; 48 hours; Day 3; Day 14 or at discharge; Day 30; Day 90; and Month 6. During follow-up, data will be collected on mortality, survival, ambulation status, living situation, modified Rankin Scale, EQ-5D-5L, Fatigue Severity Scale, AD8, Lawton-Brody Instrumental Activities of Daily Living Scale, National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale, laboratory tests, and neuroimaging findings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years at randomization;
- •Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
- •Hematoma volume ≥30 mL prior to randomization;
- •Glasgow Coma Scale (GCS) score ≥ 5;
- •Available for surgery within 72 hours after onset;
- •Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
- •Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
Exclusion Criteria
- •Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
- •Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;
- •Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
- •Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
- •Current or probable pregnancy;
- •Patients with concurrent severe illness likely to influence outcome assessment;
- •Difficulty in follow-up or poor compliance due to any cause.
Arms & Interventions
Robot-Assisted Endoscopic Minimally Invasive Surgery
Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure.
Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma.
Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded
Intervention: Robot-Assisted Endoscopic Minimally Invasive Surgery (Procedure)
Traditional Surgical Approaches
A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.
Intervention: Traditional Surgical Approaches (Procedure)
Outcomes
Primary Outcomes
Modified Rankin Scale (mRS) score at 6 months
Time Frame: up to 6 months
The primary analysis will compare differences between the two groups based on utility-weighted mRS.
Secondary Outcomes
- Ordinal shift in mRS scores at 6 months (ordinal shift)(up to 6 months)
- Favorable functional outcome at 6 months (mRS 0-1)(up to 6 months)
- Functional independence at 6 months (mRS 0-2)(up to 6 months)
- Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire(up to 6 months)
- Total length of hospital stay(up to 6 months)
- Cognitive function at 6 months(up to 6 months)
- Hematoma clearance rate at 48 hours postoperatively(up to 6 months)
- Costs during hospitalization(up to 6 months)
- Intraoperative blood loss(up to 6 months)
- Incidence of rebleeding within 14 days(up to 6 months)
- Incidence of related complications within 14 days, including pulmonary infection, aphasia, seizures, and deep vein thrombosis of the lower limbs(up to 6 months)