Tests robot-guided endoscopic surgery for large brain bleeds in the basal ganglia
Compares robot-assisted endoscopic surgery with traditional surgery in adults with large basal ganglia bleeds.
Plain-language title generated from the registry record
Registry title: A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Key facts
- Where
- Nanjing, ChinaSee the site
Where in China
- The Affiliated Drum Tower Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Trial code
- NCT06484374
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
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.
Inclusion: Age ≥18 years at randomization; Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.); Hematoma volume ≥30 mL prior to randomization; Glasgow Coma Scale (GCS) score ≥ 5; Available for surgery within 72 hours after onset; Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage; Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
Exclusion: Patients with concurrent severe illness likely to influence outcome assessment; Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage; Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage; Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations; Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes; Current or probable pregnancy; Difficulty in follow-up or poor compliance due to any cause.