Minimalnie inwazyjna chirurgia krwotoku z pnia mózgu z udziałem robota (RAINBOW-BSH)
Badania nad małoinwazyjnymi strategiami chirurgicznymi krwotoku z pnia mózgu wspomaganymi robotyką
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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Yanbing Yu, M.D.
- Numer telefonu: +86-13901114963
- E-mail: yuyanbing123@126.com
Kopia zapasowa kontaktu do badania
- Nazwa: Yulian Zhang, M.D.
- Numer telefonu: +86-13051581507
- E-mail: 398824625@qq.com
Lokalizacje studiów
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100029
- Rekrutacyjny
- China-Japan Friendship Hospital
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Kontakt:
- Yulian Zhang, M.D.
- Numer telefonu: +86-13051581507
- E-mail: 398824625@qq.com
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Kontakt:
- Yanbing Yu, M.D.
- Numer telefonu: 13901114963
- E-mail: yuyanbing123@126.com
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Pod-śledczy:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, Chiny, 100049
- Rekrutacyjny
- Aerospace Center Hospital
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Kontakt:
- Feng Yin, M.D.
- Numer telefonu: +86-13381207600
- E-mail: yinf897@163.com
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Kontakt:
- Hui Chen, M.D.
- Numer telefonu: +86-13810520648
- E-mail: 16564583@qq.com
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Guangxi
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Nanning, Guangxi, Chiny, 530021
- Rekrutacyjny
- The First Affiliated Hospital of Guangxi Medical University
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Kontakt:
- DAQIN FENG
- Numer telefonu: +8619914884494
- E-mail: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, Chiny, 100190
- Rekrutacyjny
- Hebei Provincial People's Hospital
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Kontakt:
- Tao Qian, M.D.
- Numer telefonu: +86-15931423666
- E-mail: qt1966a@163.com
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Kontakt:
- Yang Li, M.D.
- Numer telefonu: +86-18632109423
- E-mail: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, Chiny, 210008
- Rekrutacyjny
- Nanjing Drum Tower Hospital
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Kontakt:
- CHUNHUA HANG
- Numer telefonu: +8613813379309
- E-mail: hang1965@nju.edu.cn
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Nantong, Jiangsu, Chiny, 226001
- Rekrutacyjny
- Affiliated Hospital of Nantong University
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Kontakt:
- JIANHONG SHEN
- Numer telefonu: +8613506287516
- E-mail: tysjh@163.com
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Jiangxi
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Nanchang, Jiangxi, Chiny, 330006
- Rekrutacyjny
- The Second Affiliated Hospital of Nanchang University
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Kontakt:
- HUA GUO
- Numer telefonu: +8613697081718
- E-mail: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200040
- Rekrutacyjny
- Huashan Hospital Fudan University
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Kontakt:
- JIN HU
- Numer telefonu: +8618930174565
- E-mail: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, Chiny, 201199
- Rekrutacyjny
- Shanghai Minhang District Central Hospital
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Kontakt:
- FULIN XU
- Numer telefonu: +8618121270156
- E-mail: 18918169183@163.com
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Shanghai, Shanghai Municipality, Chiny, 200120
- Rekrutacyjny
- Shanghai East Hospital, Tongji University
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Kontakt:
- CHUNLONG ZHONG
- Numer telefonu: +8613917920669
- E-mail: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, Chiny, 201508
- Rekrutacyjny
- Jinshan Hospital, Fudan University
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Kontakt:
- ERSONG WANG
- Numer telefonu: wersong@aliyun +8618930815670
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chiny, 300350
- Rekrutacyjny
- Tianjin Huanhu Hospital
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Kontakt:
- JIE ZUO
- Numer telefonu: +8618920195507
- E-mail: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, Chiny, 310009
- Rekrutacyjny
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Kontakt:
- Gao Chen
- Numer telefonu: +8613738194475
- E-mail: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, Chiny, 321000
- Rekrutacyjny
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Kontakt:
- MINFENG TONG
- Numer telefonu: +8613646694178
- E-mail: Tmfhyj@sina.com
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Wenzhou, Zhejiang, Chiny, 325000
- Rekrutacyjny
- The First Affiliated Hospital of Wenzhou Medical University
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Kontakt:
- QUN LI
- Numer telefonu: +8615858002900
- E-mail: garylina@126.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
Inne nazwy:
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.
Inne nazwy:
|
|
Aktywny komparator: 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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Survival rate
Ramy czasowe: 60 days
|
60 days survival rate after follow-up |
60 days
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Ramy czasowe: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Ramy czasowe: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Ramy czasowe: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Ramy czasowe: 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
Ramy czasowe: 14 days
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis |
14 days
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Yanbing Yu, M.D., China-Japan Friendship Hospital
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 01084205031
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
The study has not yet begun; we will decide once recruitment starts.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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