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RECRUITINGINTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Umbrella Trial Who May Qualify: 1. Age ≥18 years； 2. Clinical diagnosis of spontaneous hemorrhagic stroke； Umbrella Trial Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China