A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)

Intracerebral hemorrhage (ICH) is a leading cause of stroke-related mortality and long-term disability worldwide. Conventional surgical techniques, including craniotomy and catheter-based drainage, are often associated with significant procedural risks and variable outcomes across clinical settings. Minimally invasive approaches have been proposed to reduce surgical trauma, improve precision, and enhance recovery. Recent studies, such as the ENRICH trial, have provided encouraging evidence that selected patients may benefit from early minimally invasive hematoma evacuation, though results remain heterogeneous and further validation is needed across different ICH subtypes and populations.

The RAINBOW-ICH trial has been established to address this critical gap by systematically evaluating the role of AI-assisted, robotic-guided minimally invasive neurosurgery. Advances in robotics and artificial intelligence have enabled neurosurgeons to achieve greater precision in hematoma evacuation, minimize surgical injury, and improve reproducibility of complex procedures. RAINBOW-ICH is designed as a nationwide, multicenter umbrella trial, conducted under a single master protocol, with multiple parallel randomized controlled substudies. Each substudy focuses on a distinct ICH population and directly compares AI-assisted robotic-guided hematoma evacuation with the conventional standard of care relevant to that subgroup. Specifically, RAINBOW-LBH (NCT06484374) evaluates patients with large basal ganglia hemorrhage, RAINBOW-MBH (NCT06465719) addresses moderate basal ganglia hemorrhage, RAINBOW-IVH (NCT06486480) investigates intraventricular hemorrhage, and RAINBOW-BSH (NCT06459427) targets brainstem hemorrhage.

Within each substudy, participants are randomized to receive either AI-assisted robotic-guided minimally invasive neurosurgery or the control intervention, such as conventional craniotomy, external ventricular drainage, or optimized medical management. All substudies are conducted as multicenter RCTs across China, ensuring adequate and rapid recruitment, generalizability, and rigorous evaluation of interventions in diverse clinical environments.

By integrating minimally invasive neurosurgical technologies with a unified multicenter umbrella trial design, RAINBOW-ICH represents the first large-scale effort in China to rigorously test and compare surgical strategies for ICH. The findings are expected to generate high-quality evidence, refine clinical practice, and ultimately improve neurological outcomes for patients with this devastating disease.