Basal Ganglia Hemorrhage
Conditions
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.
Interventions
PROCEDUREMinimally 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
DRUGPatients will be managed with guideline-based medications
Patients will be managed with guideline-based medications without surgery
Sponsors
Huashan Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
China-Japan Friendship Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Patients will be randomly assigned to treatment or conservative group, so masking is only for outcome assessors
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal shift in modified Rankin Scale | 6 months | Ordinal shift analysis of the modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities after stroke. The scale ranges from 0 (no symptoms) to 6 (death). This outcome assesses whether there is a shift toward better or worse functional status across the full ordinal distribution of mRS scores. |
| Excellent functional neurological outcome | 6 months | Excellent functional neurological outcome means modified Rankin scale (mRS) scores 0-1. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is. |
| Independent functional neurological outcome | 6 months | Independent functional neurological outcome means modified Rankin scale (mRS) scores 0-2. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is. |
| Health Related Quality of Life | 6 months | Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It assesses five domains: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems. |
| Hematoma evacuation rate | 30 days after treatment | Hematoma clearance rate at Day1 and Day30 after treatment |
| Total medical expenses during hospitalization | 6 month | Total medical expenses during hospitalization |
| Total length of hospital stay | 6 months | Total length of hospital stay refers to the number of days from the date of hospital admission to the date of discharge. |
| AD8 Dementia Screening | 6 months | The AD8 (Eight-item Interview to Differentiate Aging and Dementia) is a brief screening tool designed to distinguish normal aging from possible dementia. The AD8 focuses on changes in memory, orientation, judgment, and daily activities. A greater number of Yes responses indicates higher likelihood of cognitive impairment or dementia, warranting further diagnostic evaluation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 6 months | Mortality status equals to death which will be collected at all visits during the trial period |
| Serious Adverse Events (SAEs) | 6 months | The reporting and notification of SAEs follows ICH-GCP guidelines. According to the WHO International Drug Monitoring Centre (1994), an SAE is any adverse medical event that: Leading to death; Life-threatening; Requires hospitalization or prolongs existing hospitalization; Results in persistent or significant disability/incapacity; Congenital anomaly/birth defect; etc. |
Countries
China
Contacts
Primary ContactGao Chen
Outcome results
None listed