A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery
This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracra
| Condition(s) | Hematoma Brain, Large Basal Ganglia Hemorrhage |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation. |
| Who can participate | Inclusion Criteria: 1. Age ≥18 years at randomization; 2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.); 3. Hematoma volume ≥30 mL prior to randomization; 4. Glasgow Coma Scale (GCS) score ≥ 5; 5. Available for surgery within 72 hours after onset; 6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage; 7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements. Exclusion Criteria: 1. Hematoma involving the thalamus (volume \>5 mL or diameter \>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations; 2. Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation o |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Locations | Nanjing, China |
| Start date | 2025-12-20 |
| NCT ID | NCT06484374 |
| Official listing | https://clinicaltrials.gov/study/NCT06484374 |