Clinical Research Directory
Browse clinical research sites, groups, and studies.
RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Official title: A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-09-30
Completion Date
2027-12
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
AI-assisted robotic-guided endoscopic hematoma evacuation
Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.
Conventional craniotomy
Standard open surgical evacuation of hematoma through craniotomy.
AI-assisted robotic-guided puncture and hematoma evacuation
AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.
Standard medical management
Guideline-based conservative therapy without surgical hematoma evacuation.
AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
AI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.
External ventricular drainage (EVD)
Conventional ventricular catheter placement for hematoma drainage.
Locations (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China