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A Multicenter, RAndomIzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With AI-assisted Robotic guidanCe for Hemorrhagic Stroke

RecruitingNAAges 18 Years - anyAllYanbing Yu
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to observe the improvements in clinical symptoms and imaging outcomes for brainstem hemorrhage using robot-assisted stereotactic puncture, evaluate the clinical efficacy and safety of this treatment, and explore the development of a high-precision, intelligent, and individualized microsurgical diagnosis and treatment process for brainstem hemorrhage. The main questions it aims to address are: * Establish a multi-center clinical database for brainstem hemorrhage. * Clinically observe and evaluate the intervention effects of robot-assisted stereotactic puncture on brainstem hemorrhage, compare it with the traditional conservative treatment control group, and investigate its efficacy and impact on patient survival, motor evoked potentials, and the degree of neurological deficits. * Optimize the Artificial Intelligence (AI) algorithm-based robotic surgi

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📋 Eligibility rules (as published)
Participants must meet all of the following inclusion criteria: 1. Age ≥18 years at randomization; 2. Diagnosed with brainstem hemorrhage via imaging (CT, CTA, etc.); 3. Hematoma volume ≥3 mL; 4. Glasgow Coma Scale (GCS) score of 3-12; 5. Available for surgery within 48 hours after onset; 6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage; 7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements. Patients will be excluded if they meet any of the following criteria: 1. Hematoma involving other regions such as the supratentorial compartment, basal ganglia, thalamus, midbrain, or ventricles. 2. 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; 3. Any irreversible coagulation disorder or known coagulopathy; platelet count \<100,000/µL; INR \>1.4; or use of anticoagulant medication within 7 days before the current hemorrhage; 4. Current or probable pregnancy; 5. Patients with concurrent severe illness likely to influence outcome assessment; 6. Difficulty in follow-up or poor compliance due to any cause.
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What it tests

  • Robot-assisted minimally invasive puncture and aspiration surgery
  • Standard medical management
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Where

15 sites
China-Japan Friendship Hospital
Beijing, China
Aerospace Center Hospital
Beijing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Hebei Provincial People's Hospital
Shijiazhuang, China
Nanjing Drum Tower Hospital
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Huashan Hospital Fudan University
Shanghai, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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