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

NCT03899350 | Unknown

• 1 other identifier: TDSJWKICH
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzing the correlation between collected variables and patients' outcomes.

Conditions

Spontaneous Intracranial Hemorrhage; Spontaneous Intraparenchymal Cerebral Hemorrhage; Spontaneous Cerebellar Haemorrhage

Keywords

Treatment Efficacy; Intraparenchymal Hemorrhage; Surgery; Outcome; Prediction Model

Outcome Measures

Primary Outcomes (6)

• Mortality

  The mortality rate of patients undertook different treatments at 1 month.

  1 month after onset

• Mortality

  The mortality rate of patients undertook different treatments at 6 month.

  6 month after onset

• Mortality

  The mortality rate of patients undertook different treatments at 12 month.

  12 month after onset

• Neurological Outcome Assessed by modified Rankin Scale (mRS) Score

  The neurological function state of patients undertook different treatments at 1 month.

  1 month after onset

• Neurological Outcome Assessed by mRS Score

  The neurological function state of patients undertook different treatments at 6 month.

  6 month after onset

• Neurological Outcome Assessed by mRS Score

  The neurological function state of patients undertook different treatments at 12 month.

  12 month after onset

Study Arms (2)

Spontaneous Supratentorial Intracerebral Haemorrhage

Participants with spontaneous supratentorial intracerebral haemorrhage.

Other: No intervention

Spontaneous Intracerebellar Hemorrhage

Participants with spontaneous intracerebellar hemorrhage.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Spontaneous Intracerebellar Hemorrhage; Spontaneous Supratentorial Intracerebral Haemorrhage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All of the spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) patients receiving treatment in four clinical centers (Tangdu Hospital, Ankang Central Hospital, 987 Hospital of PLA Joint Logistic Support Force, and Nuclear Industry 215 Hospital of Shaanxi Province) who meet the screening criteria were invited to participate in this cohort study.

You may qualify if:

• Age 18-80；
• Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
• Admitted within 24h of ictus；
• Did not undertake treatment before enrollment;
• Informed consent to participate in the study.

You may not qualify if:

• The hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy；
• Concurrent traumatic brain injury；
• Multiple intracerebral hemorrhage；
• Undertake any surgery after onset in other hospital；
• Refuse the treatment after admission;
• History of craniocerebral surgery；
• Known advanced demential or disability before onset；
• Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
• Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
• Concurrent serious infectious disease (HIV, tuberculosis etc.)
• Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
• With indications of terminal brain hernia
• Pregnant or lactating females；
• Participation in another simultaneous trial of intracerebral hemorrhage treatment；
• Patients/relatives refuse to be followed up。

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 27636179 BACKGROUND

• 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.

  PMID: 17938297 BACKGROUND

• 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.

  PMID: 26022637 BACKGROUND

• 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.

  PMID: 30739747 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Yan Qu

  Tang-Du Hospital

  STUDY CHAIR

• Wei Guo

  Tang-Du Hospital

  STUDY DIRECTOR

Central Study Contacts

Wei Guo, M.D, Ph.D

CONTACT

86-18729985168; 18729985168@163.com

Haixiao Liu, M.D

CONTACT

86-15929315407; 56761311@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: April 2, 2019
• Study Start: July 15, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)