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

Официальное название

Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage

Обзор

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.

Вмешательства

• Процедура 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
• Другое 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

Первичные конечные точки

• Survival rate [Срок оценки: 60 days]

Вторичные конечные точки (11)

• Ordinal shift in mRS scores at 60 days and 6 months [Срок оценки: 60 days and 6 months]
• Favorable functional outcome at 60 days and 6 months (mRS 0-1) [Срок оценки: 60 days and 6 months]
• Functional independence at 60 days and 6 months (mRS 0-2) [Срок оценки: 60 days and 6 months]
• Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire [Срок оценки: 60 days and 6 months]
• Utility-weighted mRS at 60 days and 6 months [Срок оценки: 60 days and 6 months]
• Cognitive function at 60 days and 6 months [Срок оценки: 60 days and 6 months]
• Total length of hospital stay [Срок оценки: 60 days]
• Costs during hospitalization [Срок оценки: 60 days]
• ICU length of stay [Срок оценки: 60 days]
• Brainstem hematoma clearance rate on postoperative days 1, 3, and 7 [Срок оценки: 1, 3, and 7 days]
• Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis [Срок оценки: 14 days]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

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

Публикации

• 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

Идентификаторы

NCT: NCT06459427 · 01084205031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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