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RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH

RecruitingNAAges 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT07205263 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. To address this gap, the RAINBOW-ICH trial has been designed as a nationwide, multicenter, randomized umbrella trial evaluating the efficacy and safety of AI-assisted, robotic-guided minimally invasive neurosurgery compared with conventional strategies across major ICH subtypes. Under a single master protocol, RAINBOW-ICH incorporates multiple parallel randomized controlled substudies, each targeting a distinct ICH population-large basal ganglia hemorrhage, moderate basal ganglia hemorrhage, intraventricular hemorrhage, and brainstem hemorrhage. This umbrella design allows efficient use of resources while generating high-quality evidence tailored to the specific needs

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📋 Eligibility rules (as published)
Umbrella Trial Inclusion Criteria: 1. Age ≥18 years； 2. Clinical diagnosis of spontaneous hemorrhagic stroke； Umbrella Trial Exclusion Criteria: 1\. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage； Each substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.
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What it tests

  • AI-assisted robotic-guided endoscopic hematoma evacuation
  • Conventional craniotomy
  • AI-assisted robotic-guided puncture and hematoma evacuation
  • Standard medical management
  • AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
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Where

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