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The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Cerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT03899350
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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
Intracerebral Hemorrhage Other: No intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 552 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Cerebral Hemorrhage
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 month after onset ]
    The mortality rate of spontaneous intracerebral hemorrhage (sICH) patients undertook different treatments at 1 month.

  2. Mortality [ Time Frame: 6 month after onset ]
    The mortality rate of sICH patients undertook different treatments at 6 month.

  3. Mortality [ Time Frame: 12 month after onset ]
    The mortality rate of sICH patients undertook different treatments at 12 month.

  4. Neurological Outcome Assessed by modified Rankin Scale (mRS) Score [ Time Frame: 1 month after onset ]
    The neurological function state of sICH patients undertook different treatments at 1 month.

  5. Neurological Outcome Assessed by mRS Score [ Time Frame: 6 month after onset ]
    The neurological function state of sICH patients undertook different treatments at 6 month.

  6. Neurological Outcome Assessed by mRS Score [ Time Frame: 12 month after onset ]
    The neurological function state of sICH patients undertook different treatments at 12 month.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All of the spontaneous intracerebral hemorrhage patients receiving treatment in Tangdu Hospital during 2019-2022.
Criteria

Inclusion Criteria:

  1. Age 18-80;
  2. Diagnosed with sICH 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:

  1. Intracerebral hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy;
  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。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899350


Contacts
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Contact: Wei Guo, M.D, Ph.D 86-18729985168 18729985168@163.com
Contact: Haixiao Liu, M.D 86-15929315407 56761311@qq.com

Locations
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China, Shaanxi
Tandu Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Wei Guo, M.D Ph.D    86-18729985168    18729985168@163.com   
Contact: Haixiao Liu, M.D    86-15929315407    56761311@qq.com   
Principal Investigator: Yan Qu, M.D, Ph.D         
Principal Investigator: Wei Guo, M.D Ph.D         
Sub-Investigator: Haixiao Liu, M.D         
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Chair: Yan Qu Tang-Du Hospital
Study Director: Wei Guo Tang-Du Hospital

Additional Information:

Publications:
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.

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT03899350     History of Changes
Other Study ID Numbers: TDSJWKICH
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tang-Du Hospital:
Treatment Efficacy
Intracerebral Hemorrhage
Surgery
Outcome
Prediction Model

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases