RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH
NCT ID: NCT07205263
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-09-30
2027-12-31
Brief Summary
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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.
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Detailed Description
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The RAINBOW-ICH trial has been established to address this critical gap by systematically evaluating the role of AI-assisted, robotic-guided minimally invasive neurosurgery. Advances in robotics and artificial intelligence have enabled neurosurgeons to achieve greater precision in hematoma evacuation, minimize surgical injury, and improve reproducibility of complex procedures. RAINBOW-ICH is designed as a nationwide, multicenter umbrella trial, conducted under a single master protocol, with multiple parallel randomized controlled substudies. Each substudy focuses on a distinct ICH population and directly compares AI-assisted robotic-guided hematoma evacuation with the conventional standard of care relevant to that subgroup. Specifically, RAINBOW-LBH (NCT06484374) evaluates patients with large basal ganglia hemorrhage, RAINBOW-MBH (NCT06465719) addresses moderate basal ganglia hemorrhage, RAINBOW-IVH (NCT06486480) investigates intraventricular hemorrhage, and RAINBOW-BSH (NCT06459427) targets brainstem hemorrhage.
Within each substudy, participants are randomized to receive either AI-assisted robotic-guided minimally invasive neurosurgery or the control intervention, such as conventional craniotomy, external ventricular drainage, or optimized medical management. All substudies are conducted as multicenter RCTs across China, ensuring adequate and rapid recruitment, generalizability, and rigorous evaluation of interventions in diverse clinical environments.
By integrating minimally invasive neurosurgical technologies with a unified multicenter umbrella trial design, RAINBOW-ICH represents the first large-scale effort in China to rigorously test and compare surgical strategies for ICH. The findings are expected to generate high-quality evidence, refine clinical practice, and ultimately improve neurological outcomes for patients with this devastating disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RAINBOW-LBH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate the efficacy and safety of AI-assisted robotic-guided endoscopic hematoma evacuation for patients with large basal ganglia hemorrhage (LBH).
AI-assisted robotic-guided endoscopic hematoma evacuation
Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.
Conventional craniotomy
Standard open surgical evacuation of hematoma through craniotomy.
RAINBOW-MBH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with moderate basal ganglia hemorrhage (MBH).
AI-assisted robotic-guided puncture and hematoma evacuation
AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.
Standard medical management
Guideline-based conservative therapy without surgical hematoma evacuation.
RAINBOW-IVH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided endoscopic ventricular hematoma evacuation with external ventricular drainage for patients with intraventricular hemorrhage (IVH)
AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
AI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.
External ventricular drainage (EVD)
Conventional ventricular catheter placement for hematoma drainage.
RAINBOW-BSH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with brainstem hemorrhage (BSH).
AI-assisted robotic-guided puncture and hematoma evacuation
AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.
Standard medical management
Guideline-based conservative therapy without surgical hematoma evacuation.
Interventions
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AI-assisted robotic-guided endoscopic hematoma evacuation
Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.
Conventional craniotomy
Standard open surgical evacuation of hematoma through craniotomy.
AI-assisted robotic-guided puncture and hematoma evacuation
AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.
Standard medical management
Guideline-based conservative therapy without surgical hematoma evacuation.
AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
AI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.
External ventricular drainage (EVD)
Conventional ventricular catheter placement for hematoma drainage.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of spontaneous hemorrhagic stroke；
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Huashan Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Related Links
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A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Large Basal Ganglia Hemorrhage (RAINBOW-LBH)
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-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 IntraVentricular Hemorrhage (RAINBOW-IVH)
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for BrainStem Hemorrhage (RAINBOW-BSH)
Other Identifiers
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2023ZD0505000
Identifier Type: -
Identifier Source: org_study_id
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