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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Utility-weighted modified Rankin Scale (UW-mRS) — Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration) 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.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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