RecruitingNot ApplicableNCT07205263

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)


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

1,000 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Age ≥18 years;
  • Clinical diagnosis of spontaneous hemorrhagic stroke;

Exclusion Criteria1

  • \. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage;

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Interventions

PROCEDUREAI-assisted robotic-guided endoscopic hematoma evacuation

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

PROCEDUREConventional craniotomy

Standard open surgical evacuation of hematoma through craniotomy.

PROCEDUREAI-assisted robotic-guided puncture and hematoma evacuation

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

OTHERStandard medical management

Guideline-based conservative therapy without surgical hematoma evacuation.

PROCEDUREAI-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.

PROCEDUREExternal 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

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NCT07205263


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