NCT06670456招募中不适用
Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage
De-zhi Kang6 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- Neurological Function
研究概览
简要总结
The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.
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
- •Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
- •Underwent no surgical intervention;
排除标准
- •Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
- •Pre-stroke life expectancy < 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure [NYHA: III-IV], severe chronic obstructive pulmonary disease [III-IV], chronic kidney disease requiring hemodialysis)
- •Severe dependency or incorporation to interview (e.g., pre-stroke mRS>3, severe dementia, intractable mental disease)
- •Unsuitable for inclusion in the study in the opinion of the investigator
结局指标
主要结局
Neurological Function
时间窗: Discharge; 3, 6, 12 months after enrollment
Assessed with modified Rankin Scale (0-6)
Mortality
时间窗: Discharge; 3, 6, 12 months after enrollment
次要结局
- Complications(Admission period; the 3, 6, 12 months after enrollment)
- Cognitive Status(The 3, 6, 12 months after enrollment)
研究者
De-zhi Kang
Prof.
First Affiliated Hospital of Fujian Medical University
研究点 (6)
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