Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07205263

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-08

1000

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

T

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of spontaneous hemorrhagic stroke
Not Eligible

You will not qualify if you...

  • Presence of radiologically diagnosed cerebrovascular abnormalities
  • Ischemic infarction converting to intracerebral hemorrhage
  • Recurrence of intracerebral hemorrhage within the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

G

Gao Chen, MD.

CONTACT

X

Xiaobo Yu, MD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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