The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Cerebral Hemorrhage
Study Details
Study Description
Brief Summary
Spontaneous intracerebral hemorrhage is an important type of cerebrovascular disease. The disease has an acute onset, a serious condition, and a high mortality rate. Besides, the survivors always live with severe neurological dysfunction. It is essential to determine the influencing factors of poor prognosis, estimate patient's condition and predict the prognosis timely.
This study consists of two parts. The first part establishes a cohort of spontaneous intracerebral hemorrhage, analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested cohort is 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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Mortality [1 month after onset]
The mortality rate of spontaneous intracerebral hemorrhage (sICH) patients undertook different treatments at 1 month.
- Mortality [6 month after onset]
The mortality rate of sICH patients undertook different treatments at 6 month.
- Mortality [12 month after onset]
The mortality rate of sICH patients undertook different treatments at 12 month.
- Neurological Outcome Assessed by modified Rankin Scale (mRS) Score [1 month after onset]
The neurological function state of sICH patients undertook different treatments at 1 month.
- Neurological Outcome Assessed by mRS Score [6 month after onset]
The neurological function state of sICH patients undertook different treatments at 6 month.
- Neurological Outcome Assessed by mRS Score [12 month after onset]
The neurological function state of sICH patients undertook different treatments at 12 month.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-80;
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Diagnosed with sICH by Computed Tomography;
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Admitted within 24h of ictus;
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Did not undertake treatment before enrollment;
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Informed consent to participate in the study.
Exclusion Criteria:
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Intracerebral hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy;
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Concurrent traumatic brain injury;
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Multiple intracerebral hemorrhage;
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Undertake any surgery after onset in other hospital;
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Refuse the treatment after admission;
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History of craniocerebral surgery;
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Known advanced demential or disability before onset;
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Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
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Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
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Concurrent serious infectious disease (HIV, tuberculosis etc.)
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Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
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With indications of terminal brain hernia
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Pregnant or lactating females;
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Participation in another simultaneous trial of intracerebral hemorrhage treatment;
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Patients/relatives refuse to be followed up。
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tandu Hospital, Fourth Military Medical University | Xi'an | Shaanxi | China | 710038 |
Sponsors and Collaborators
- Tang-Du Hospital
Investigators
- Study Chair: Yan Qu, Tang-Du Hospital
- Study Director: Wei Guo, Tang-Du Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Erratum in: Lancet. 2019 Apr 20;393(10181):1596.
- 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.
- 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.
- TDSJWKICH