The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
Spontaneous intracranial 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 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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。
结局指标
主要结局
Mortality
时间窗: 12 month after onset
The mortality rate of patients undertook different treatments at 12 month.
Neurological Outcome Assessed by modified Rankin Scale (mRS) Score
时间窗: 1 month after onset
The neurological function state of patients undertook different treatments at 1 month.
Neurological Outcome Assessed by mRS Score
时间窗: 12 month after onset
The neurological function state of patients undertook different treatments at 12 month.
次要结局
未报告次要终点