RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH
A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)
Second Affiliated Hospital, School of Medicine, Zhejiang University
1,000 participants
Sep 30, 2025
INTERVENTIONAL
Conditions
Summary
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 of different ICH subgroups, thereby supporting a more patient-centered approach to care.
Eligibility
Inclusion Criteria2
- Age ≥18 years;
- Clinical diagnosis of spontaneous hemorrhagic stroke;
Exclusion Criteria1
- \. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage;
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Interventions
Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.
Standard open surgical evacuation of hematoma through craniotomy.
AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.
Guideline-based conservative therapy without surgical hematoma evacuation.
AI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.
Conventional ventricular catheter placement for hematoma drainage.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07205263