A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage
NCT ID: NCT04647162
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2022-01-01
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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medical group
Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
life support
The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。
surgical group
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
hematoma evacuation by craniotomy
The intervention method of hematoma evacuation is under craniotomy.
hematoma evacuation by stereotactic puncture
The intervention method of hematoma evacuation is under stereotactic puncture.
hematoma evacuation by neuroendoscopy
The intervention method of hematoma evacuation is under neuroendoscopy.
Interventions
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hematoma evacuation by craniotomy
The intervention method of hematoma evacuation is under craniotomy.
hematoma evacuation by stereotactic puncture
The intervention method of hematoma evacuation is under stereotactic puncture.
hematoma evacuation by neuroendoscopy
The intervention method of hematoma evacuation is under neuroendoscopy.
life support
The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。
Eligibility Criteria
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Inclusion Criteria
2. GCS 5\~7 and HV≥5ml on admission (the HV in intraventricular system being excluded).
3. Family members consenting to randomize and signing informed consent form (ICF).
4. Time from onset to admission less than 24 hours.
5. Age:18 years or older.
Exclusion Criteria
2. GCS≥8 and HV\<5ml.
3. Time from onset to admission over 24 hours.
4. Patients with platelet count \< 100,000, International Normalized Ratio (INR)\> 1.4, or an elevated prothrombin time (PT) and activated partial thromboplastin time (APTT).
5. Multiple ICH.
6. Accompanying hydrocephalus that requires surgical management
7. Irreversible brainstem failure (bilateral fixed, dilated pupils and extensor motor posturing, GCS≤4).
8. A previous history of ICH.
9. Any serious concurrent illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
10. Pregnant patients.
11. Patients' family members refuse HE.
12. Any other condition that the investigator believes would present a significant hazard to the subject if the investigational therapy were initiated.
13. Participating in another simultaneous trial of ICH treatment.
18 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Chao You, MD
former director of the department of neurosurgery, West China Hospital
Principal Investigators
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Chao You, MD
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine
Gaozhou, Guangdong, China
Guangdong Sanjiu Brain Hospital
Guangzhou, Guangdong, China
University of Chinese Academy of Sciences Shenzhen Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of South China University of Technology
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
General Hospital of the Eastern Theater
Nanjing, Jiangsu, China
Shanxi Bethune hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
The Third Hospital of the People's Liberation Army
Baoji, , China
The seventh medical center of the Army General Hospital
Beijing, , China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Huashan Hospital of Fudan University
Shanghai, , China
Shanghai No.10 hospital
Shanghai, , China
Xuhui Hospital of Zhongshan Hospital affiliated to Fudan
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Hongwei Cheng, MD
Role: primary
Dezhi Kang, MD
Role: primary
Jinhua Yang, MD
Role: primary
Linsen Mu, MD
Role: primary
Xuezheng Fan, MD
Role: primary
Jiangang Liu, MD
Role: primary
Gang Chen, MD
Role: primary
Hongsheng Liang, MD
Role: primary
Zhan Liu, MD
Role: primary
Chiyuan Ma, MD
Role: primary
Xinming Ding, MD
Role: primary
Chao You, MD
Role: primary
Zongping Li, MD
Role: primary
Xiaoping Tang, MD
Role: primary
Rongjun Zhang
Role: primary
Hongtian Zhang, MD
Role: primary
Fengqiang Liu
Role: primary
Jian Yu, MD
Role: primary
Liang Gao, MD
Role: primary
Shujie Sun, MD
Role: primary
References
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Ye Z, Huang X, Han Z, Shao B, Cheng J, Wang Z, Zhang Z, Xiao M. Three-year prognosis of first-ever primary pontine hemorrhage in a hospital-based registry. J Clin Neurosci. 2015 Jul;22(7):1133-8. doi: 10.1016/j.jocn.2014.12.024. Epub 2015 May 14.
Tao C, Li H, Wang J, You C. Predictors of Surgical Results in Patients with Primary Pontine Hemorrhage. Turk Neurosurg. 2016;26(1):77-83. doi: 10.5137/1019-5149.JTN.12634-14.1.
Huang K, Ji Z, Sun L, Gao X, Lin S, Liu T, Xie S, Zhang Q, Xian W, Zhou S, Gu Y, Wu Y, Wang S, Lin Z, Pan S. Development and Validation of a Grading Scale for Primary Pontine Hemorrhage. Stroke. 2017 Jan;48(1):63-69. doi: 10.1161/STROKEAHA.116.015326. Epub 2016 Dec 8.
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Ichimura S, Bertalanffy H, Nakaya M, Mochizuki Y, Moriwaki G, Sakamoto R, Fukuchi M, Fujii K. Surgical Treatment for Primary Brainstem Hemorrhage to Improve Postoperative Functional Outcomes. World Neurosurg. 2018 Dec;120:e1289-e1294. doi: 10.1016/j.wneu.2018.09.055. Epub 2018 Sep 19.
Mangiardi JR, Epstein FJ. Brainstem haematomas: review of the literature and presentation of five new cases. J Neurol Neurosurg Psychiatry. 1988 Jul;51(7):966-76. doi: 10.1136/jnnp.51.7.966.
Rohde V, Berns E, Rohde I, Gilsbach JM, Ryang YM. Experiences in the management of brainstem hematomas. Neurosurg Rev. 2007 Jul;30(3):219-23; discussion 223-4. doi: 10.1007/s10143-007-0081-9. Epub 2007 May 8.
Murata Y, Yamaguchi S, Kajikawa H, Yamamura K, Sumioka S, Nakamura S. Relationship between the clinical manifestations, computed tomographic findings and the outcome in 80 patients with primary pontine hemorrhage. J Neurol Sci. 1999 Aug 15;167(2):107-11. doi: 10.1016/s0022-510x(99)00150-1.
Cao S, Zheng M, Hua Y, Chen G, Keep RF, Xi G. Hematoma Changes During Clot Resolution After Experimental Intracerebral Hemorrhage. Stroke. 2016 Jun;47(6):1626-31. doi: 10.1161/STROKEAHA.116.013146. Epub 2016 Apr 28.
Wilkinson DA, Keep RF, Hua Y, Xi G. Hematoma clearance as a therapeutic target in intracerebral hemorrhage: From macro to micro. J Cereb Blood Flow Metab. 2018 Apr;38(4):741-745. doi: 10.1177/0271678X17753590. Epub 2018 Jan 19.
Parraga RG, Possatti LL, Alves RV, Ribas GC, Ture U, de Oliveira E. Microsurgical anatomy and internal architecture of the brainstem in 3D images: surgical considerations. J Neurosurg. 2016 May;124(5):1377-95. doi: 10.3171/2015.4.JNS132778. Epub 2015 Oct 30.
He Q, Wang J, Ma L, Li H, Tao C, You C. Safety of surgical Treatment In severe primary Pontine haemorrhage Evacuation (STIPE): study protocol for a multi-centre, randomised, controlled, open-label trial. BMJ Open. 2022 Aug 23;12(8):e062233. doi: 10.1136/bmjopen-2022-062233.
Other Identifiers
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STIPE
Identifier Type: -
Identifier Source: org_study_id