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

February 10, 2026 updated by: Yanbing Yu

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yulian Zhang, M.D.
  • Phone Number: +86-13051581507
  • Email: 398824625@qq.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xu Yang, M.D.
      • Beijing, Beijing Municipality, China, 100049
        • Aerospace Center Hospital
        • Contact:
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 100190
        • Hebei Provincial People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted minimally invasive puncture and aspiration surgery
The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage
Procedure: Robot-assisted minimally invasive puncture and aspiration surgery
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.
Other Names:
  • Neurosurgical Robot
Other: Standard medical management
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.
Other Names:
  • Medical therapy
Active Comparator: Standard medical management
The control group will undergo conventional medical conservative management.
Other: Standard medical management
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.
Other Names:
  • Medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 60 days
60 days survival rate after follow-up
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordinal shift in mRS scores at 60 days and 6 months
Time Frame: 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.
60 days and 6 months
Favorable functional outcome at 60 days and 6 months (mRS 0-1)
Time Frame: 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.
60 days and 6 months
Functional independence at 60 days and 6 months (mRS 0-2)
Time Frame: 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.
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
Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire
60 days and 6 months
Utility-weighted mRS at 60 days and 6 months
Time Frame: 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.
60 days and 6 months
Cognitive function at 60 days and 6 months
Time Frame: 60 days and 6 months
Cognitive function at 60 days and 6 months
60 days and 6 months
Total length of hospital stay
Time Frame: 60 days
Total length of hospital stay
60 days
Costs during hospitalization
Time Frame: 60 days
Costs during hospitalization
60 days
ICU length of stay
Time Frame: 60 days
ICU length of stay
60 days
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Time Frame: 1, 3, and 7 days
The change in hematoma volume compared to the preoperative CT scan was assessed 1, 3, and 7 days postoperatively.
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
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanbing Yu

Investigators

  • Study Chair: Yanbing Yu, M.D., China-Japan Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01084205031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study has not yet begun; we will decide once recruitment starts.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Robotic Surgical Procedures

Clinical Trials on Robot-assisted minimally invasive puncture and aspiration surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe