Cirurgia Minimamente Invasiva Assistida por Robô para Hemorragia do Tronco Encefálico (RAINBOW-BSH)
Pesquisa sobre estratégias cirúrgicas minimamente invasivas para hemorragia do tronco cerebral assistida 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yanbing Yu, M.D.
- Número de telefone: +86-13901114963
- E-mail: yuyanbing123@126.com
Estude backup de contato
- Nome: Yulian Zhang, M.D.
- Número de telefone: +86-13051581507
- E-mail: 398824625@qq.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Recrutamento
- China-Japan Friendship Hospital
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Contato:
- Yulian Zhang, M.D.
- Número de telefone: +86-13051581507
- E-mail: 398824625@qq.com
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Contato:
- Yanbing Yu, M.D.
- Número de telefone: 13901114963
- E-mail: yuyanbing123@126.com
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Subinvestigador:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, China, 100049
- Recrutamento
- Aerospace Center Hospital
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Contato:
- Feng Yin, M.D.
- Número de telefone: +86-13381207600
- E-mail: yinf897@163.com
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Contato:
- Hui Chen, M.D.
- Número de telefone: +86-13810520648
- E-mail: 16564583@qq.com
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Guangxi
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Nanning, Guangxi, China, 530021
- Recrutamento
- The First Affiliated Hospital of Guangxi Medical University
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Contato:
- DAQIN FENG
- Número de telefone: +8619914884494
- E-mail: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, China, 100190
- Recrutamento
- Hebei Provincial People's Hospital
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Contato:
- Tao Qian, M.D.
- Número de telefone: +86-15931423666
- E-mail: qt1966a@163.com
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Contato:
- Yang Li, M.D.
- Número de telefone: +86-18632109423
- E-mail: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Recrutamento
- Nanjing Drum Tower Hospital
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Contato:
- CHUNHUA HANG
- Número de telefone: +8613813379309
- E-mail: hang1965@nju.edu.cn
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Nantong, Jiangsu, China, 226001
- Recrutamento
- Affiliated Hospital of Nantong University
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Contato:
- JIANHONG SHEN
- Número de telefone: +8613506287516
- E-mail: tysjh@163.com
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- Recrutamento
- The Second Affiliated Hospital of Nanchang University
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Contato:
- HUA GUO
- Número de telefone: +8613697081718
- E-mail: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200040
- Recrutamento
- Huashan Hospital Fudan University
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Contato:
- JIN HU
- Número de telefone: +8618930174565
- E-mail: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, China, 201199
- Recrutamento
- Shanghai Minhang District Central Hospital
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Contato:
- FULIN XU
- Número de telefone: +8618121270156
- E-mail: 18918169183@163.com
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Shanghai, Shanghai Municipality, China, 200120
- Recrutamento
- Shanghai East Hospital, Tongji University
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Contato:
- CHUNLONG ZHONG
- Número de telefone: +8613917920669
- E-mail: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, China, 201508
- Recrutamento
- Jinshan Hospital, Fudan University
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Contato:
- ERSONG WANG
- Número de telefone: wersong@aliyun +8618930815670
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300350
- Recrutamento
- Tianjin Huanhu Hospital
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Contato:
- JIE ZUO
- Número de telefone: +8618920195507
- E-mail: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recrutamento
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Contato:
- Gao Chen
- Número de telefone: +8613738194475
- E-mail: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, China, 321000
- Recrutamento
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Contato:
- MINFENG TONG
- Número de telefone: +8613646694178
- E-mail: Tmfhyj@sina.com
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Wenzhou, Zhejiang, China, 325000
- Recrutamento
- The First Affiliated Hospital of Wenzhou Medical University
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Contato:
- QUN LI
- Número de telefone: +8615858002900
- E-mail: garylina@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
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.
Outros nomes:
|
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Survival rate
Prazo: 60 days
|
60 days survival rate after follow-up |
60 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Prazo: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Prazo: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Prazo: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Prazo: 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
Prazo: 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
- Cadeira de estudo: Yanbing Yu, M.D., China-Japan Friendship Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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Última Atualização Postada (Real)
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Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01084205031
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The study has not yet begun; we will decide once recruitment starts.
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