A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage

A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage

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.

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.

Inclusion Criteria:

1. Age ≥18 years at randomization;
2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
3. Hematoma volume ≥30 mL prior to randomization;
4. Glasgow Coma Scale (GCS) score ≥ 5;
5. Available for surgery within 72 hours after onset;
6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.

Exclusion Criteria:

1. Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
2. 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;
3. Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
4. 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;
5. Current or probable pregnancy;
6. Patients with concurrent severe illness likely to influence outcome assessment;
7. Difficulty in follow-up or poor compliance due to any cause.