Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,374
- 试验地点
- 1
- 主要终点
- hematoma expansion
研究概览
简要总结
The purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.
详细描述
This is a investigator-initiated, multi-center, prospective, registered cohort study. The study is intended to enroll 4000 patients with intracerebral hemorrhage from 50 hospital in China. Clinical and imaging data, as well as the results of laboratory examination will be collected to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spontaneous intracerebral hemorrhage(sICH)
- •Admission within 24 hours of symptom onset
- •CT available at 24 hours
- •Informed consent obtained
排除标准
- •Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc.
- •Deep coma at admission (GCS≤8)
- •Intended to have a surgery within 24 hours
- •Congenital coagulation dysfunction
- •Previous intracerebral hematoma have not been absorbed
结局指标
主要结局
hematoma expansion
时间窗: 24-48 hours from symptom onset
non-contrast CT scan: the enlargement of hematoma ≥6ml
Functional dependence
时间窗: 3 months
modified Rankin Scale score ≥3 (a global measure of disability on a seven-level scale, with scores ranging from 0 (no symptoms) to 6 (death), higher scores mean a better or worse outcome )
Cerebrovascular death
时间窗: 3 months
Death due to one of the following events: ischemic stroke or hemorrhagic stroke
Recurrence of intracerebral hemorrhage
时间窗: 90 days from symptom onset
non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma
Cardiovascular death
时间窗: 3 months
Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure
次要结局
- New ischemic stroke(3 months)
- New subarachnoid hemorrhage(3 months)
- Other cardiovascular events(3 months)
研究者
Xingquan Zhao
Professor of Neurology and Stroke Center
Beijing Tiantan Hospital