Tests robot-assisted surgery for bleeding in the brainstem
Compares robot-guided minimally invasive surgery with standard care in adults with brainstem bleeding.
Plain-language title generated from the registry record
Registry title: A Multicenter, RAndomIzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With AI-assisted Robotic guidanCe for Hemorrhagic Stroke
Key facts
- Where
- Beijing, Hangzhou, Jinhua, Nanchang, Nanjing, Nanning, Nantong, Shanghai, Shijiazhuang, Tianjin, and Wenzhou, ChinaSee the 15 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a brainstem bleed (brainstem hemorrhage) who can have surgery within 48 hours of onset. It compares robot-assisted minimally invasive surgery with standard non-surgical care.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Brainstem hemorrhage shown on a scan (CT, CTA, etc.). Hematoma volume of 3 mL or more. Glasgow Coma Scale score of 3 to 12. Surgery possible within 48 hours after onset.
- Earlier treatment
- No anticoagulant (blood-thinning) medication within 7 days before this hemorrhage.
- Biomarker or test result
- Platelet count not below 100,000/µL and INR not above 1.4.
Main reasons for not taking part
- Bleeding that also involves other brain areas such as the basal ganglia, thalamus, midbrain or ventricles
- Brain blood vessel problems such as ruptured aneurysm, AVM or Moyamoya disease, or a brain bleed within the past year
- Known coagulation (blood clotting) disorder
- Current or probable pregnancy
- Other severe illness likely to affect the results, or difficulty with follow-up
Read by machine on 9 November 2026.
Where in China
- Aerospace center hospitalBeijing, ChinaTaking people
- China-Japan Friendship HospitalBeijing, ChinaTaking people
- The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of MedicineJinhua, ChinaTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTaking people
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
- Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Jinshan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Shanghai East Hospital, Tongji UniversityShanghai, ChinaTaking people
- Shanghai Minhang District Central HospitalShanghai, ChinaTaking people
- Hebei Provincial People's HospitalShijiazhuang, ChinaTaking people
- Tianjin Huanhu HospitalTianjin, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yanbing Yu
- Trial code
- NCT06459427
- Record updated
- 23 September 2026
- Original description
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:Read full original descriptionShow less
Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage
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 surgical assistance system, and explore the prediction of preoperative brainstem hematoma stability and hematoma path planning.
Participants in the experimental group will:
* Undergo robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture * Receive conservative non-surgical treatment.
If there is a control group: the researchers will compare the conservative non-surgical treatment group to evaluate the effectiveness of robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture.
Participants must meet all of the following inclusion criteria:; Age ≥18 years at randomization；; Diagnosed with brainstem hemorrhage via imaging (CT, CTA, etc.)；; Hematoma volume ≥3 mL；; Glasgow Coma Scale (GCS) score of 3-12；; Available for surgery within 48 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; Patients will be excluded if they meet any of the following criteria:; Hematoma involving other regions such as the supratentorial compartment, basal ganglia, thalamus, midbrain, or ventricles; 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；; 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；; 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.