The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage
NCT ID: NCT03899350
Last Updated: 2023-09-22
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
1000 participants
OBSERVATIONAL
2019-07-15
2025-12-31
Brief Summary
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Detailed Description
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This study consists of two parts. The first part establishes a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested case-control study nested in this cohort will be established to analyse the influence of some other factors. The biological specimens are tested. The collected data were analysed to find out the risk factors of poor prognosis and establish a predictive model.
Recruitment and follow-up of the participants is expected to continue after the initial goal is achieved. As a large sample database of intracranial hemorrhage, this cohort will provide more research data for the future exploration of more clinical problems.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Spontaneous Supratentorial Intracerebral Haemorrhage
Participants with spontaneous supratentorial intracerebral haemorrhage.
No intervention
No intervention
Spontaneous Intracerebellar Hemorrhage
Participants with spontaneous intracerebellar hemorrhage.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
3. Admitted within 24h of ictus;
4. Did not undertake treatment before enrollment;
5. Informed consent to participate in the study.
Exclusion Criteria
2. Concurrent traumatic brain injury;
3. Multiple intracerebral hemorrhage;
4. Undertake any surgery after onset in other hospital;
5. Refuse the treatment after admission;
6. History of craniocerebral surgery;
7. Known advanced demential or disability before onset;
8. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
9. Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
10. Concurrent serious infectious disease (HIV, tuberculosis etc.)
11. Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
12. With indications of terminal brain hernia
13. Pregnant or lactating females;
14. Participation in another simultaneous trial of intracerebral hemorrhage treatment;
15. Patients/relatives refuse to be followed up。
18 Years
80 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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Yan Qu
Role: STUDY_CHAIR
Tang-Du Hospital
Wei Guo
Role: STUDY_DIRECTOR
Tang-Du Hospital
Locations
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Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Sun GC, Chen XL, Hou YZ, Yu XG, Ma XD, Liu G, Liu L, Zhang JS, Tang H, Zhu RY, Zhou DB, Xu BN. Image-guided endoscopic surgery for spontaneous supratentorial intracerebral hematoma. J Neurosurg. 2017 Sep;127(3):537-542. doi: 10.3171/2016.7.JNS16932. Epub 2016 Sep 16.
Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association/American Stroke Association Stroke Council; American Heart Association/American Stroke Association High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Circulation. 2007 Oct 16;116(16):e391-413. doi: 10.1161/CIRCULATIONAHA.107.183689.
Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
Other Identifiers
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TDSJWKICH
Identifier Type: -
Identifier Source: org_study_id
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