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

Official title

Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage

Overview

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.

Interventions

• 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
• 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

Primary outcome measures

• Survival rate [Time frame: 60 days]

Secondary outcome measures (11)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 3 centers

• China-Japan Friendship Hospital — Beijing
• Aerospace Center Hospital — Beijing
• Hebei Provincial People's Hospital — Shijiazhuang

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. PMID 3992454

Identifiers

NCT: NCT06459427 · 01084205031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗