RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

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)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

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