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

Recruiting now · Not applicable

Conditions studied: Basal Ganglia Hemorrhage, Intraventricular Hemorrhage, Brainstem Stroke, Intracranial Hemorrhage, Spontaneous

In brief

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.

Key facts

Study ID
NCT07205263
Run by
Second Affiliated Hospital, Zhejiang University, School of Medicine
People needed
1000
Starts
2025-09-30
Expected to finish
2027-12-01
Last updated by the study team
2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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