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

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.

NCT Number	NCT07205263
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Huashan Hospital, China-Japan Friendship Hospital
Conditions	Basal Ganglia Hemorrhage, Intraventricular Hemorrhage, Brainstem Stroke, Intracranial Hemorrhage, Spontaneous
Enrollment	1,000 participants
Start Date	2025-09-30
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-01-08