A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)

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

About this trial

A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.

Eligibility criteria

Qualifiers

Age ≥18 years at randomization

Hypertensive basal ganglia hemorrhage confirmed by CT/CTA

Hematoma volume 15-30 mL (excluding 30 mL)

Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)

Disqualifiers

Hematoma involving the thalamus, midbrain, or other areas

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

Signs of impending brain herniation, such as midline shift >1 cm or changes in the ipsilateral pupil;

Any irreversible coagulopathy disorders or known coagulation system disease; platelet count <100,000; INR >1.4; use of anticoagulants within 7 days prior to this hemorrhage;

Trial design

Treatments tested in this trial

  • Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
  • Patients will be managed with guideline-based medications

Treatment groups

330 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Huashan Hospital

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

China-Japan Friendship Hospital

Collaborator