RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH
RAINBOW-ICH
A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)
1 other identifier
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 8, 2026
August 1, 2025
2.2 years
September 25, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Utility-weighted modified Rankin Scale (UW-mRS)
The mRS is a 7-level ordinal scale used to evaluate functional outcomes after stroke. The categories are defined as follows: 0 = No symptoms 1. = No significant disability. Able to carry out all usual activities, despite some symptoms. 2. = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. = Moderate disability. Requires some help, but able to walk unassisted. 4. = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. = Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. = Dead Utility-weighted modified Rankin Scale (UW-mRS) , which applies utility values to each mRS category as shown below： mRS 0= UW-mRS 1；mRS 1= UW-mRS 0.91; mRS 2= UW-mRS 0.76; mRS 3= UW-mRS 0.65; mRS 4= UW-mRS 0.33; mRS 5= UW-mRS 0; mRS 6= UW-mRS 0.
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Secondary Outcomes (5)
Ordinal shift in modified Rankin Scale
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Excellent functional neurological outcome
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Independent functional neurological outcome
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Health Related Quality of Life
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Total length of hospital stay
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Other Outcomes (1)
Mortality
Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)
Study Arms (4)
RAINBOW-LBH substudy
EXPERIMENTALThis 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).
RAINBOW-MBH substudy
EXPERIMENTALThis 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).
RAINBOW-IVH substudy
EXPERIMENTALThis 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)
RAINBOW-BSH substudy
EXPERIMENTALThis 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).
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years；
- Clinical diagnosis of spontaneous hemorrhagic stroke；
You may not qualify if:
- \. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage；
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Related Links
- 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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2025
First Posted
October 3, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 8, 2026
Record last verified: 2025-08