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

NCT06459427 | Not Yet Recruiting DMC

• 1 other identifier: 01084205031
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Brain Stem Hemorrhage; Robotic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Survival rate

  60 days survival rate after follow-up

  60 days

Secondary Outcomes (11)

• Ordinal shift in mRS scores at 60 days and 6 months

  60 days and 6 months

• Favorable functional outcome at 60 days and 6 months (mRS 0-1)

  60 days and 6 months

• Functional independence at 60 days and 6 months (mRS 0-2)

  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

  60 days and 6 months

Study Arms (2)

Robot-assisted minimally invasive puncture and aspiration surgery

EXPERIMENTAL

The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage

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.

Other: Standard medical management

Interventions

Robot-assisted minimally invasive puncture and aspiration surgery PROCEDURE

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.

Also known as: Neurosurgical Robot

Robot-assisted minimally invasive puncture and aspiration surgery

Standard medical management OTHER

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.

Also known as: Medical therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Yanbing Yu: lead

Study Sites (3)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, 100190, China

Location

Related Publications (1)

• 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.

  PMID: 3992454 BACKGROUND

MeSH Terms

Interventions

Nutrition Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yanbing Yu, M.D.

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Yanbing Yu, M.D.

CONTACT

+86-13901114963; yuyanbing123@126.com

Yulian Zhang, M.D.

CONTACT

+86-13051581507; 398824625@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Neurosurgery

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 14, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)