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

Zhejiang University

Status: Not yet enrolling

Conditions: Basal Ganglia Hemorrhage

Treatments: Drug: Patients will be managed with guideline-based medications; Procedure: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System

Study type: Interventional

Funder types: Other

Identifiers

NCT06465719

IRB-2024-0017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 312 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18
2. Diagnosed with hypertensive basal ganglia hemorrhage (CT, CTA, etc.)
3. Hematoma volume 15 - 30mL
4. With functional impairments (e.g., motor or sensory aphasia, muscle strength ≤ 3 in hemiparetic limbs, or NIHSS ≥ 15)
5. CT shows stable hematoma (a CT scan at least 6 hours after the diagnostic CT, with hematoma volume increase < 5 ml)
6. Randomized intervention can be initiated within 72 hours
7. Prior mRS ≤1
8. Patients who have Consent

Exclusion criteria

1. Hematoma involving the thalamus, midbrain, or other areas
2. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage
3. Brain herniation
4. Any irreversible coagulation disorders or known coagulation system diseases
5. Patients with severe concomitant diseases that may interfere with outcome assessment
6. Pregnancy or possible pregnancy
7. Difficulty in follow-up or potential poor adherence due to various factors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

312 participants in 2 patient groups

Tract-based AI Robot Guiding System Group

Experimental group

Description:

Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System

Treatment:

Procedure: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System

Conservative Group

Sham Comparator group

Description:

Patients will be managed with guideline-based medications without surgery

Treatment:

Drug: Patients will be managed with guideline-based medications