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.
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)
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;
Parallel
Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
Procedure/SurgeryBasal 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
DrugPatients will be managed with guideline-based medications without surgery
Utility-weighted modified Rankin Scale (UW-mRS)
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.
Ordinal shift in modified Rankin Scale
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
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
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
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.
Mortality
Mortality status equals to death which will be collected at all visits during the trial period
Serious Adverse Events (SAEs)
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.
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Huashan Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
China-Japan Friendship Hospital
Collaborator
