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Recruiting NCT06465719

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

No phase Interventional Basal Ganglia Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System, Patients will be managed with guideline-based medications.
Who it may be relevant to
Registry conditions: Basal Ganglia Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)

Overview

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.

Detailed description

Basal ganglion hemorrhage is one of the most common subtypes of cerebral hemorrhage, characterized by high morbidity, mortality, and disability rates. Minimally invasive surgery for cerebral hemorrhage, particularly utilizing a fiber tract-based AI Robot Guiding System, has shown potential advantages for patient prognosis. However, there is currently no standardized practice or robust evidence confirming the effectiveness and safety of this technology for small-volume basal ganglion hemorrhage. Therefore, we are conducting 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.

Interventions

  • Procedure Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
    Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System
  • Drug Patients will be managed with guideline-based medications
    Patients will be managed with guideline-based medications without surgery

Primary outcome measures

  • Utility-weighted modified Rankin Scale (UW-mRS) [Time frame: 6 months]
Secondary outcome measures (8)
  • Ordinal shift in modified Rankin Scale [Time frame: 6 months]
  • Excellent functional neurological outcome [Time frame: 6 months]
  • Independent functional neurological outcome [Time frame: 6 months]
  • Health Related Quality of Life [Time frame: 6 months]
  • Total length of hospital stay [Time frame: 6 months]
  • AD8 Dementia Screening [Time frame: 6 months]
  • Hematoma evacuation rate [Time frame: 30 days after treatment]
  • Total medical expenses during hospitalization [Time frame: 6 month]

Eligibility criteria

Inclusion criteria

  • 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)
  • CT shows stable hematoma (≥6h interval, change <5 mL)
  • GCS ≥9
  • Surgery feasible within 72h after onset
  • Pre-ICH mRS ≤1
  • Informed consent obtained according to laws and ethics

Exclusion criteria

  • 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;
  • Pregnant or possibly pregnant
  • Patients with severe concomitant diseases that may interfere with outcome assessment
  • Poor compliance or follow-up difficulties

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06465719 · IRB-2024-0017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗