Robot-assisted minimally invasive puncture for brainstem hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares robot-assisted stereotactic puncture and aspiration to standard medical management for brainstem hemorrhage. It aims to build a multi-center database, evaluate clinical and imaging outcomes, and refine an AI-assisted robotic guidance system to predict hematoma stability and guide microsurgical treatment. The study will measure survival, motor evoked potentials, and neurological deficits to determine potential benefits and safety. Eligibility includes adults with significant brainstem hemorrhage suitable for surgery within 48 hours and no widespread hemorrhagic involvement. Exclusion criteria focus on other brain regions affected, certain vascular abnormalities, recent recurrences, and coagulation disorders.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• Aerospace Center Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Hebei Provincial People's Hospital
  Shijiazhuang, Hebei, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yanbing Yu, M.D.
• Email: yuyanbing123@126.com
• Phone: +86-13901114963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.