A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
198 participants
Dec 20, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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.
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Interventions
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 b
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.
Locations(1)
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NCT06484374