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

Not Applicable

Not yet recruiting

• Conditions: Basal Ganglia Hemorrhage
• Interventions: Procedure: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System; Drug: Patients will be managed with guideline-based medications

• Registration Number: NCT06465719
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Study Start: 2025-06-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tract-based AI Robot Guiding System Group	Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System	Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System
Conservative Group	Patients will be managed with guideline-based medications	Patients will be managed with guideline-based medications without surgery

Primary Outcome Measures

Name	Time	Method
Utility Weighted mRS	180 days of follow-up	Utility Weighted mRS at 180 days

Secondary Outcome Measures

Name	Time	Method
Ordinal shift of mRS	180 days of follow-up	Ordinal shift of mRS at 180 days
Excellent recovery rate	180 days of follow-up	The rate of mRS 0 or 1 at D180
Independency rate	180 days of follow-up	The rate of mRS 0-2 at D180
Mortality rate	180 days of follow-up	Mortality rate at 180 days of follow-up
Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL≤3)	180 days of follow-up	Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL≤3) at 180 days of follow-up
Hematoma evacuation rate	1 day and 30 days after treatment	Hematoma clearance rate at D1 and D30 after treatment
Duration of hospitalization	90 days after treatment	Duration of hospitalization
Total medical expenses during hospitalization	6 month after treatment	Total medical expenses during hospitalization

Trial Locations

Locations (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China