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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a large bleed in the basal ganglia of the brain caused by high blood pressure, who can have surgery within 72 hours of onset.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Bleeding in the basal ganglia confirmed on imaging (CT, CTA, etc.). Blood clot volume of 30 mL or more. Glasgow Coma Scale score of 5 or higher.
- Earlier treatment
- Surgery must be possible within 72 hours after the bleed started. No blood thinner (anticoagulant) use in the 7 days before this bleed.
- Biomarker or test result
- Platelet count not below 100,000 and INR not above 1.4. Before this bleed, a Modified Rankin Scale score of 1 or less.
Main reasons for not taking part
- Blood clot reaching the thalamus (over 5 mL or over 2 cm (0.8 in)), midbrain or ventricles (Graeb score 3 or higher)
- Ruptured aneurysm, arteriovenous malformation (AVM) or Moyamoya disease
- Signs of impending herniation, such as midline shift over 1 cm (0.4 in) or pupil changes
- Known clotting disorder
- Current or probable pregnancy
Read by machine on 12 November 2026.
Where in China
- The Affiliated Drum Tower Hospital of Nanjing University Medical SchoolNanjing, ChinaContact: Chunhua HangTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.