A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Recruiting now · Not applicable
Conditions studied: Hematoma Brain, Large Basal Ganglia Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT06484374
- Run by
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- People needed
- 198
- Starts
- 2025-12-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Current or probable pregnancy;
- Patients with concurrent severe illness likely to influence outcome assessment;
- Difficulty in follow-up or poor compliance due to any cause.
Where it is running
- The Affiliated Drum Tower Hospital of Nanjing University Medical School — Nanjing, China (enrolling)
Full record on ClinicalTrials.gov
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