Cirugía mínimamente invasiva asistida por robot para la hemorragia del tronco encefálico (RAINBOW-BSH)
Investigación sobre estrategias quirúrgicas mínimamente invasivas para la hemorragia del tronco encefálico asistidas por robótica
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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanbing Yu, M.D.
- Número de teléfono: +86-13901114963
- Correo electrónico: yuyanbing123@126.com
Copia de seguridad de contactos de estudio
- Nombre: Yulian Zhang, M.D.
- Número de teléfono: +86-13051581507
- Correo electrónico: 398824625@qq.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Reclutamiento
- China-Japan Friendship Hospital
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Contacto:
- Yulian Zhang, M.D.
- Número de teléfono: +86-13051581507
- Correo electrónico: 398824625@qq.com
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Contacto:
- Yanbing Yu, M.D.
- Número de teléfono: 13901114963
- Correo electrónico: yuyanbing123@126.com
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Sub-Investigador:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, Porcelana, 100049
- Reclutamiento
- Aerospace Center Hospital
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Contacto:
- Feng Yin, M.D.
- Número de teléfono: +86-13381207600
- Correo electrónico: yinf897@163.com
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Contacto:
- Hui Chen, M.D.
- Número de teléfono: +86-13810520648
- Correo electrónico: 16564583@qq.com
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Guangxi
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Nanning, Guangxi, Porcelana, 530021
- Reclutamiento
- The First Affiliated Hospital of Guangxi Medical University
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Contacto:
- DAQIN FENG
- Número de teléfono: +8619914884494
- Correo electrónico: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, Porcelana, 100190
- Reclutamiento
- Hebei Provincial People's Hospital
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Contacto:
- Tao Qian, M.D.
- Número de teléfono: +86-15931423666
- Correo electrónico: qt1966a@163.com
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Contacto:
- Yang Li, M.D.
- Número de teléfono: +86-18632109423
- Correo electrónico: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210008
- Reclutamiento
- Nanjing Drum Tower Hospital
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Contacto:
- CHUNHUA HANG
- Número de teléfono: +8613813379309
- Correo electrónico: hang1965@nju.edu.cn
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Nantong, Jiangsu, Porcelana, 226001
- Reclutamiento
- Affiliated Hospital of Nantong University
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Contacto:
- JIANHONG SHEN
- Número de teléfono: +8613506287516
- Correo electrónico: tysjh@163.com
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- Reclutamiento
- The Second Affiliated Hospital of Nanchang University
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Contacto:
- HUA GUO
- Número de teléfono: +8613697081718
- Correo electrónico: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200040
- Reclutamiento
- Huashan Hospital Fudan University
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Contacto:
- JIN HU
- Número de teléfono: +8618930174565
- Correo electrónico: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, Porcelana, 201199
- Reclutamiento
- Shanghai Minhang District Central Hospital
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Contacto:
- FULIN XU
- Número de teléfono: +8618121270156
- Correo electrónico: 18918169183@163.com
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Shanghai, Shanghai Municipality, Porcelana, 200120
- Reclutamiento
- Shanghai East Hospital, Tongji University
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Contacto:
- CHUNLONG ZHONG
- Número de teléfono: +8613917920669
- Correo electrónico: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, Porcelana, 201508
- Reclutamiento
- Jinshan Hospital, Fudan University
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Contacto:
- ERSONG WANG
- Número de teléfono: wersong@aliyun +8618930815670
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300350
- Reclutamiento
- Tianjin Huanhu Hospital
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Contacto:
- JIE ZUO
- Número de teléfono: +8618920195507
- Correo electrónico: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- Reclutamiento
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Contacto:
- Gao Chen
- Número de teléfono: +8613738194475
- Correo electrónico: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, Porcelana, 321000
- Reclutamiento
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Contacto:
- MINFENG TONG
- Número de teléfono: +8613646694178
- Correo electrónico: Tmfhyj@sina.com
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Wenzhou, Zhejiang, Porcelana, 325000
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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Contacto:
- QUN LI
- Número de teléfono: +8615858002900
- Correo electrónico: garylina@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Robot-assisted minimally invasive puncture and aspiration surgery
The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage |
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.
Otros nombres:
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.
Otros nombres:
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Comparador activo: Standard medical management
The control group will undergo conventional medical conservative 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Survival rate
Periodo de tiempo: 60 days
|
60 days survival rate after follow-up |
60 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Periodo de tiempo: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Periodo de tiempo: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Periodo de tiempo: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Periodo de tiempo: 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
Periodo de tiempo: 14 days
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis |
14 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Yanbing Yu, M.D., China-Japan Friendship Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01084205031
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The study has not yet begun; we will decide once recruitment starts.
Información sobre medicamentos y dispositivos, documentos del estudio
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