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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years;

• Clinical diagnosis of spontaneous hemorrhagic stroke;

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Gao Chen, MD.
d-chengao@zju.edu.cn
+86 0571 87784813
Backup
Xiaobo Yu, MD.
blzk2008@zju.edu.cn
+86 0571 87784816
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 1000
Treatments
Experimental: RAINBOW-LBH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate the efficacy and safety of AI-assisted robotic-guided endoscopic hematoma evacuation for patients with large basal ganglia hemorrhage (LBH).
Experimental: RAINBOW-MBH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with moderate basal ganglia hemorrhage (MBH).
Experimental: RAINBOW-IVH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided endoscopic ventricular hematoma evacuation with external ventricular drainage for patients with intraventricular hemorrhage (IVH)
Experimental: RAINBOW-BSH substudy
This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with brainstem hemorrhage (BSH).
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, China-Japan Friendship Hospital, Huashan Hospital
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov