Actively Recruiting
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-02-17
198
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at randomization
- Diagnosed with hypertensive basal ganglia hemorrhage by imaging (CT, CTA, etc.)
- Hematoma volume 30 mL or more prior to randomization
- Glasgow Coma Scale score 5 or higher
- Surgery available within 72 hours after hemorrhage onset
- Modified Rankin Scale score 1 or less before this hemorrhage
- Informed consent obtained according to laws and ethics requirements
You will not qualify if you...
- Hematoma involving thalamus (volume over 5 mL or diameter over 2 cm), midbrain, or ventricles (Graeb score 3 or higher), or other locations
- Cerebral vascular abnormalities such as ruptured aneurysms, arteriovenous malformations, or Moyamoya disease
- Hemorrhagic transformation of ischemic infarcts or recent (within 1 year) recurrence of intracerebral hemorrhage
- Signs of impending brain herniation like midline shift over 1 cm or changes in pupil size on the same side
- Irreversible coagulation disorders, platelet count below 100,000, INR over 1.4, or anticoagulant medication use within 7 days before hemorrhage
- Current or probable pregnancy
- Severe illness likely to affect outcome assessment
- Difficulty in follow-up or poor compliance for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
Actively Recruiting
Research Team
C
Chun-Hua Hang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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