A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al… (NCT06484374) | Clinical Trial Compass
RecruitingNot Applicable
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
China198 participantsStarted 2025-12-20
Plain-language 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
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. Hematoma involving the thalamus (volume \>5 mL or diameter \>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
✕. 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;
✕. Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
✕. 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;
✕
What they're measuring
1
Modified Rankin Scale (mRS) score at 6 months
Timeframe: up to 6 months
Trial details
NCT IDNCT06484374
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School