About this trial
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 criteria
Qualifiers
Age ≥18 years;
Clinical diagnosis of spontaneous hemorrhagic stroke;
Disqualifiers
None
Trial design
Treatments tested in this trial
- AI-assisted robotic-guided endoscopic hematoma evacuation
- Conventional craniotomy
- AI-assisted robotic-guided puncture and hematoma evacuation
- Standard medical management
- AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
- External ventricular drainage (EVD)
Treatment groups
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Huashan Hospital
Collaborator
China-Japan Friendship Hospital
Collaborator