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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.