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

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.

Conditions

• Basal Ganglia Hemorrhage
• Intraventricular Hemorrhage
• Brainstem Stroke
• Intracranial Hemorrhage, Spontaneous

Interventions

PROCEDURE

AI-assisted robotic-guided endoscopic hematoma evacuation

Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.

PROCEDURE

Conventional craniotomy

Standard open surgical evacuation of hematoma through craniotomy.

PROCEDURE

AI-assisted robotic-guided puncture and hematoma evacuation

AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.

OTHER

Standard medical management

Guideline-based conservative therapy without surgical hematoma evacuation.

PROCEDURE

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.

PROCEDURE

External ventricular drainage (EVD)

Conventional ventricular catheter placement for hematoma drainage.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations