Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-09-30
Last updated
2026-01-08
Condition(s) studied
Basal Ganglia Hemorrhage
Investigational drug(s) / intervention(s)
Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding SystemPatients will be managed with guideline-based medications
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
Patients will be managed with guideline-based medications: Patients will be managed with guideline-based medications without surgery
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years at randomization
2. Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
3. Hematoma volume 15-30 mL (excluding 30 mL)
4. Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)
5. CT shows stable hematoma (≥6h interval, change \<5 mL)
6. GCS ≥9
7. Surgery feasible within 72h after onset
8. Pre-ICH mRS ≤1
9. Informed consent obtained according to laws and ethics
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. Signs of impending brain herniation, such as midline shift \>1 cm or changes in the ipsilateral pupil;
4. 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;
5. Pregnant or possibly pregnant
6. Patients with severe concomitant diseases that may interfere with outcome assessment
7. Poor compliance or follow-up difficulties
Primary outcome measure(s)
Utility-weighted modified Rankin Scale (UW-mRS) — 6 months The mRS is a 7-level ordinal scale used to evaluate functional outcomes after stroke. The categories are defined as follows:
0 = No symptoms；
1. = No significant disability. Able to carry out all usual activities, despite some symptoms；
2. = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities；
3. = Moderate disability. Requires some help, but able to walk unassisted；
4. = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted；
5. = Severe disability. Requires constant nursing care and attention, bedridden, incontinent；
6. = Dead； Utility-weighted modified Rankin Scale (UW-mRS), which applies utility values to each mRS category as shown below： mRS 0= UW-mRS 1；mRS 1= UW-mRS 0.91; mRS 2= UW-mRS 0.76; mRS 3= UW-mRS 0.65; mRS 4= UW-mRS 0.33; mRS 5= UW-mRS 0; mRS 6= UW-mRS 0.
Trial sites (1)
Facility
City
Region
Status
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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