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

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

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.

Umbrella Trial Inclusion Criteria:

1. Age ≥18 years；
2. Clinical diagnosis of spontaneous hemorrhagic stroke；

Umbrella Trial Exclusion Criteria:

1. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage；

Each substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.