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

Sponsor

Tang-Du Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03899350

Collaborator

(none)

552

Enrollment

Location

53.6

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

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
Intracerebral Hemorrhage	Other: No intervention

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

552 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

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

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80；
Diagnosed with sICH by Computed Tomography;
Admitted within 24h of ictus；
Did not undertake treatment before enrollment;
Informed consent to participate in the study.

Exclusion Criteria:

Intracerebral 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。