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A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)

RecruitingNAAges 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ18 years at randomization 2. Hypertensive basal ganglia hemorrhage confirmed by CT/CTA 3. Hematoma volume 15-30 mL (excluding 30 mL) 4. Functional impairment (aphasia, hemiparesis with strength โ‰ค3, or NIHSS โ‰ฅ15) 5. CT shows stable hematoma (โ‰ฅ6h interval, change \<5 mL) 6. GCS โ‰ฅ9 7. Surgery feasible within 72h after onset 8. Pre-ICH mRS โ‰ค1 9. Informed consent obtained according to laws and ethics Exclusion Criteria: 1. Hematoma involving the thalamus, midbrain, or other areas 2. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage 3. Signs of impending brain herniation, such as midline shift \>1 cm or changes in the ipsilateral pupil; 4. 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; 5. Pregnant or possibly pregnant 6. Patients with severe concomitant diseases that may interfere with outcome assessment 7. Poor compliance or follow-up difficulties
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What it tests

  • Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
  • Patients will be managed with guideline-based medications
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Where

1 site
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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