About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
- Patients will be managed with guideline-based medications
Treatment groups
Sponsors and collaborators
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