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.
Age ≥18 years；
Clinical diagnosis of spontaneous hemorrhagic stroke；
None
Parallel
AI-assisted robotic-guided endoscopic hematoma evacuation
Procedure/SurgerySurgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.
Conventional craniotomy
Procedure/SurgeryStandard open surgical evacuation of hematoma through craniotomy.
AI-assisted robotic-guided puncture and hematoma evacuation
Procedure/SurgeryAI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.
Standard medical management
Other interventionGuideline-based conservative therapy without surgical hematoma evacuation.
AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
Procedure/SurgeryAI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.
External ventricular drainage (EVD)
Procedure/SurgeryConventional ventricular catheter placement for hematoma drainage.
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.
Ordinal shift in modified Rankin Scale
Ordinal shift analysis of the modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities after stroke. The scale ranges from 0 (no symptoms) to 6 (death). This outcome assesses whether there is a shift toward better or worse functional status across the full ordinal distribution of mRS scores.
Excellent functional neurological outcome
Excellent functional neurological outcome means modified Rankin scale (mRS) scores 0-1. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.
Independent functional neurological outcome
Independent functional neurological outcome means modified Rankin scale (mRS) scores 0-2. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.
Health Related Quality of Life
Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It assesses five domains: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems.
Mortality
Mortality status equals to death which will be collected at all visits during the trial period
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Huashan Hospital
Collaborator
China-Japan Friendship Hospital
Collaborator
