Brain Stem HemorrhageRAINBOW-BSHNCT06459427
A Multicenter, RAndomIzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With AI-assisted Robotic guidanCe for Hemorrhagic Stroke
A study testing Robot-assisted minimally invasive puncture and aspiration surgery and Standard medical management in people with Brain Stem Hemorrhage and Robotic Surgical Procedures, run by Yanbing Yu at 15 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Stem Hemorrhage, Robotic Surgical Procedures
- What is being tested?
- Robot-assisted minimally invasive puncture and aspiration surgery and Standard medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 15 sitesChina
- Study dates
- 23 May 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Yanbing Yu, M.D., 13901114963, yuyanbing123@126.com
Yulian Zhang, M.D., +86-13051581507, 398824625@qq.com
- Recruiting
Aerospace Center Hospital
Beijing, Beijing Municipality, 100049
Feng Yin, M.D., +86-13381207600, yinf897@163.com
Hui Chen, M.D., +86-13810520648, 16564583@qq.com
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Gao Chen, +8613738194475, d-chengao@zju.edu.cn
- Recruiting
Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
Jinhua, Zhejiang, 321000
MINFENG TONG, +8613646694178, Tmfhyj@sina.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
HUA GUO, +8613697081718, ndefy02014@ncu.edu.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
CHUNHUA HANG, +8613813379309, hang1965@nju.edu.cn
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
DAQIN FENG, +8619914884494, 13807713918@163.com
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
JIANHONG SHEN, +8613506287516, tysjh@163.com
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
JIN HU, +8618930174565, hujin@fudan.edu.cn
- Recruiting
Shanghai East Hospital, Tongji University
Shanghai, Shanghai Municipality, 200120
CHUNLONG ZHONG, +8613917920669, drchunlongzhong@tongji.edu.cn
- Recruiting
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality, 201199
FULIN XU, +8618121270156, 18918169183@163.com
- Recruiting
Jinshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201508
ERSONG WANG, +8618930815670 ext. wersong@aliyun
- Recruiting
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, 100190
Tao Qian, M.D., +86-15931423666, qt1966a@163.com
Yang Li, M.D., +86-18632109423, 772355464@qq.com
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300350
JIE ZUO, +8618920195507, luckywhg@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
QUN LI, +8615858002900, garylina@126.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Brain Stem Hemorrhage, Robotic Surgical Procedures
- Being tested
- Robot-assisted minimally invasive puncture and aspiration surgery, Standard medical management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted minimally invasive puncture and aspiration surgeryProcedure or surgery
Also called Neurosurgical Robot
Positioning and surgical operation will be performed according to the robot navigation system protocols. Preoperative imaging data will be used for precise surgical planning, including the construction of a three-dimensional (3D) preoperative visualization model. The 3D reconstruction and CT data will be imported into the AI robot-assisted stereotactic system, which, after mapping to the patient's skull, automatically designs the surgical target, calculates coordinate values, plans the puncture trajectory, and determines the cranial entry point. Different surgical approaches will be selected based on the location and shape of the hematoma, and individualized parameters, including puncture direction and trajectory length, will be generated for each patient. During the procedure, the robot will assist with stereotactic puncture, while the patient's heart rate and blood pressure are closely monitored.
Standard medical managementOther
Also called Medical therapy
According to the "Chinese Neurosurgical Expert Consensus on the Diagnosis and Treatment of Primary Brainstem Hemorrhage", conventional medical treatment includes oxygen therapy, specialized nursing care, blood pressure control (maintaining BP at ≤140/90 mmHg), sedation, intracranial pressure reduction, arousal promotion, gastric protection, maintenance of internal homeostasis, infection prevention, neuro-nutrition, brain function support, nutritional support, and overall systemic management; For comatose patients, ensure a patent airway, provide nebulization and sputum clearance, prevent respiratory depression, and improve respiratory function. Closely monitor the patient's condition and provide active symptomatic treatment as needed. Regular cranial CT scans are performed to evaluate intracranial status, and in cases of ventricular hemorrhage or obstructive hydrocephalus, lateral ventricular puncture and drainage may be performed.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted minimally invasive puncture and aspiration surgery | Experimental | The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage Receives: Procedure: Robot-assisted minimally invasive puncture and aspiration surgery; Other: Standard medical management |
| Standard medical management | Active comparator | The control group will undergo conventional medical conservative management. Receives: Other: Standard medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
60 days survival rate after follow-up
Measured: 60 days
Secondary outcomes (11)
Ordinal shift in mRS scores at 60 days and 6 months
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions.
Measured: 60 days and 6 months
Favorable functional outcome at 60 days and 6 months (mRS 0-1)
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions.
Measured: 60 days and 6 months
Functional independence at 60 days and 6 months (mRS 0-2)
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions.
Measured: 60 days and 6 months
Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire
Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire
Measured: 60 days and 6 months
Utility-weighted mRS at 60 days and 6 months
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions.
Measured: 60 days and 6 months
Cognitive function at 60 days and 6 months
Cognitive function at 60 days and 6 months
Measured: 60 days and 6 months
Total length of hospital stay
Total length of hospital stay
Measured: 60 days
Costs during hospitalization
Costs during hospitalization
Measured: 60 days
ICU length of stay
ICU length of stay
Measured: 60 days
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
The change in hematoma volume compared to the preoperative CT scan was assessed 1, 3, and 7 days postoperatively.
Measured: 1, 3, and 7 days
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start23 May 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Stem HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanbing Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbing Yu, China-Japan Friendship Hospital
- Investigators
- Yanbing Yu, M.D., Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459427
- Sponsor's protocol ID
- 01084205031
- Acronym
- RAINBOW-BSH
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study has not yet begun; we will decide once recruitment starts.
Publications
Lui TN, Fairholm DJ, Shu TF, Chang CN, Lee ST, Chen HR. Surgical treatment of spontaneous cerebellar hemorrhage. Surg Neurol. 1985 Jun;23(6):555-8. doi: 10.1016/0090-3019(85)90002-3.
PubMed 3992454
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage
- ClinicalTrials.gov ID
- NCT06459427
- Acronym / sponsor ID
- RAINBOW-BSH / 01084205031
- Conditions
- Brain Stem Hemorrhage, Robotic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Yanbing YuUniversity, hospital or other
- Study start
- 23 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted minimally invasive puncture and aspiration surgery | Experimental | Procedure: Robot-assisted minimally invasive puncture and aspiration surgery, Other: Standard medical managementThe intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage |
| Standard medical management | Active comparator | Other: Standard medical managementThe control group will undergo conventional medical conservative management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted minimally invasive puncture and aspiration surgeryAlso: Neurosurgical RobotPositioning and surgical operation will be performed according to the robot navigation system protocols. Preoperative imaging data will be used for precise surgical planning, including the construction of a three-dimensional (3D) preoperative visualization model. The 3D reconstruction and CT data will be imported into the AI robot-assisted stereotactic system, which, after mapping to the patient's skull, automatically designs the surgical target, calculates coordinate values, plans the puncture trajectory, and determines the cranial entry point. Different surgical approaches will be selected based on the location and shape of the hematoma, and individualized parameters, including puncture direction and trajectory length, will be generated for each patient. During the procedure, the robot will assist with stereotactic puncture, while the patient's heart rate and blood pressure are closely monitored. | Procedure or surgery | Robot-assisted minimally invasive puncture and aspiration surgery |
| Standard medical managementAlso: Medical therapyAccording to the "Chinese Neurosurgical Expert Consensus on the Diagnosis and Treatment of Primary Brainstem Hemorrhage", conventional medical treatment includes oxygen therapy, specialized nursing care, blood pressure control (maintaining BP at ≤140/90 mmHg), sedation, intracranial pressure reduction, arousal promotion, gastric protection, maintenance of internal homeostasis, infection prevention, neuro-nutrition, brain function support, nutritional support, and overall systemic management; For comatose patients, ensure a patent airway, provide nebulization and sputum clearance, prevent respiratory depression, and improve respiratory function. Closely monitor the patient's condition and provide active symptomatic treatment as needed. Regular cranial CT scans are performed to evaluate intracranial status, and in cases of ventricular hemorrhage or obstructive hydrocephalus, lateral ventricular puncture and drainage may be performed. | Other | Robot-assisted minimally invasive puncture and aspiration surgery, Standard medical management |
Primary outcome
Survival rate
Time frame: 60 days
60 days survival rate after follow-up
11 secondary outcomes
Ordinal shift in mRS scores at 60 days and 6 months
Time frame: 60 days and 6 months
Favorable functional outcome at 60 days and 6 months (mRS 0-1)
Time frame: 60 days and 6 months
Functional independence at 60 days and 6 months (mRS 0-2)
Time frame: 60 days and 6 months
Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire
Time frame: 60 days and 6 months
Utility-weighted mRS at 60 days and 6 months
Time frame: 60 days and 6 months
Cognitive function at 60 days and 6 months
Time frame: 60 days and 6 months
Total length of hospital stay
Time frame: 60 days
Costs during hospitalization
Time frame: 60 days
ICU length of stay
Time frame: 60 days
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Time frame: 1, 3, and 7 days
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 3992454Lui TN, Fairholm DJ, Shu TF, Chang CN, Lee ST, Chen HR. Surgical treatment of spontaneous cerebellar hemorrhage. Surg Neurol. 1985 Jun;23(6):555-8. doi: 10.1016/0090-3019(85)90002-3.
- Individual participant dataSharing planned: No. The study has not yet begun; we will decide once recruitment starts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanbing Yu, M.D. study chair
China-Japan Friendship Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted minimally invasive puncture and aspiration surgery and Standard medical management in people with Brain Stem Hemorrhage and Robotic Surgical Procedures, run by Yanbing Yu at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanbing Yu, M.D. (+86-13901114963, yuyanbing123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06459427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.