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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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.

Eligibility criteria

Qualifiers

Age ≥18 years;

Clinical diagnosis of spontaneous hemorrhagic stroke;

Disqualifiers

None

Trial design

Treatments tested in this trial

  • AI-assisted robotic-guided endoscopic hematoma evacuation
  • Conventional craniotomy
  • AI-assisted robotic-guided puncture and hematoma evacuation
  • Standard medical management
  • AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
  • External ventricular drainage (EVD)

Treatment groups

1,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

Huashan Hospital

Collaborator

China-Japan Friendship Hospital

Collaborator