Robotassistert minimalt invasiv kirurgi for hjernestammeblødning (RAINBOW-BSH)
Forskning på minimalt invasive kirurgiske strategier for hjernestammeblødning assistert av robotikk
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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Yanbing Yu, M.D.
- Telefonnummer: +86-13901114963
- E-post: yuyanbing123@126.com
Studer Kontakt Backup
- Navn: Yulian Zhang, M.D.
- Telefonnummer: +86-13051581507
- E-post: 398824625@qq.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100029
- Rekruttering
- China-Japan Friendship Hospital
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Ta kontakt med:
- Yulian Zhang, M.D.
- Telefonnummer: +86-13051581507
- E-post: 398824625@qq.com
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Ta kontakt med:
- Yanbing Yu, M.D.
- Telefonnummer: 13901114963
- E-post: yuyanbing123@126.com
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Underetterforsker:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, Kina, 100049
- Rekruttering
- Aerospace Center Hospital
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Ta kontakt med:
- Feng Yin, M.D.
- Telefonnummer: +86-13381207600
- E-post: yinf897@163.com
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Ta kontakt med:
- Hui Chen, M.D.
- Telefonnummer: +86-13810520648
- E-post: 16564583@qq.com
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Rekruttering
- The First Affiliated Hospital of Guangxi Medical University
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Ta kontakt med:
- DAQIN FENG
- Telefonnummer: +8619914884494
- E-post: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, Kina, 100190
- Rekruttering
- Hebei Provincial People's Hospital
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Ta kontakt med:
- Tao Qian, M.D.
- Telefonnummer: +86-15931423666
- E-post: qt1966a@163.com
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Ta kontakt med:
- Yang Li, M.D.
- Telefonnummer: +86-18632109423
- E-post: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital
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Ta kontakt med:
- CHUNHUA HANG
- Telefonnummer: +8613813379309
- E-post: hang1965@nju.edu.cn
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Nantong, Jiangsu, Kina, 226001
- Rekruttering
- Affiliated Hospital of Nantong University
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Ta kontakt med:
- JIANHONG SHEN
- Telefonnummer: +8613506287516
- E-post: tysjh@163.com
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
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Ta kontakt med:
- HUA GUO
- Telefonnummer: +8613697081718
- E-post: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200040
- Rekruttering
- Huashan Hospital Fudan University
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Ta kontakt med:
- JIN HU
- Telefonnummer: +8618930174565
- E-post: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, Kina, 201199
- Rekruttering
- Shanghai Minhang District Central Hospital
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Ta kontakt med:
- FULIN XU
- Telefonnummer: +8618121270156
- E-post: 18918169183@163.com
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Shanghai, Shanghai Municipality, Kina, 200120
- Rekruttering
- Shanghai East Hospital, Tongji University
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Ta kontakt med:
- CHUNLONG ZHONG
- Telefonnummer: +8613917920669
- E-post: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, Kina, 201508
- Rekruttering
- Jinshan Hospital, Fudan University
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Ta kontakt med:
- ERSONG WANG
- Telefonnummer: wersong@aliyun +8618930815670
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300350
- Rekruttering
- Tianjin Huanhu Hospital
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Ta kontakt med:
- JIE ZUO
- Telefonnummer: +8618920195507
- E-post: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310009
- Rekruttering
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Ta kontakt med:
- Gao Chen
- Telefonnummer: +8613738194475
- E-post: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, Kina, 321000
- Rekruttering
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Ta kontakt med:
- MINFENG TONG
- Telefonnummer: +8613646694178
- E-post: Tmfhyj@sina.com
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Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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Ta kontakt med:
- QUN LI
- Telefonnummer: +8615858002900
- E-post: garylina@126.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
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.
Andre navn:
|
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Aktiv 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Survival rate
Tidsramme: 60 days
|
60 days survival rate after follow-up |
60 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Tidsramme: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Tidsramme: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Tidsramme: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Tidsramme: 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
Tidsramme: 14 days
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis |
14 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Yanbing Yu, M.D., China-Japan Friendship Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 01084205031
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The study has not yet begun; we will decide once recruitment starts.
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