A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
Second Affiliated Hospital, School of Medicine, Zhejiang University
330 participants
Sep 30, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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)
- GCS ≥9
- Surgery feasible within 72h after onset
- Pre-ICH mRS ≤1
- Informed consent obtained according to laws and ethics
Exclusion Criteria7
- 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
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Interventions
Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System
Patients will be managed with guideline-based medications without surgery
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06465719