A Multicentre, RAndomlsed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new robot-guiding system that uses artificial intelligence (AI) to help doctors safely remove blood clots from the basal ganglia in the brain, a condition known as basal ganglia hemorrhage. The trial aims to find out if this advanced technology can improve patients' recovery both during and after the surgery compared to traditional methods.

To participate, you must be between 18 and 70 years old and diagnosed with a specific type of brain bleed that meets certain criteria, including a certain size of the hemorrhage and a level of consciousness. If you qualify and choose to take part, you'll be randomly assigned to either receive the surgery using the AI robot system or to continue with regular medical treatment. The trial is not yet recruiting, but it will involve multiple centers across the country, giving a diverse group of patients the chance to contribute to this important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18
• • 2. Diagnosed with hypertensive basal ganglia hemorrhage (CT, CTA, etc.)
• • 3. Hematoma volume 15 - 30mL
• • 4. With functional impairments (e.g., motor or sensory aphasia, muscle strength ≤ 3 in hemiparetic limbs, or NIHSS ≥ 15)
• • 5. CT shows stable hematoma (a CT scan at least 6 hours after the diagnostic CT, with hematoma volume increase \< 5 ml)
• • 6. Randomized intervention can be initiated within 72 hours
• • 7. Prior mRS ≤1
• • 8. Patients who have Consent
• 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. Brain herniation
• • 4. Any irreversible coagulation disorders or known coagulation system diseases
• • 5. Patients with severe concomitant diseases that may interfere with outcome assessment
• • 6. Pregnancy or possible pregnancy
• • 7. Difficulty in follow-up or potential poor adherence due to various factors