NCT05035134Unknown不适用
Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The type and content of circulating exosomes
研究概览
简要总结
The purpose of this study is to observe the relationship between the changes of circulating exosomes and the development and outcome of the disease in patients with intracerebral hemorrhage, and to search for early serum markers and potential intervention targets for disease monitoring in patients with intracerebral hemorrhage
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
- 是
入选标准
- •No systematic treatment was given before admission;
- •The patients were diagnosed with cerebral hemorrhage, and had imaging evidence;
- •The age was more than 18 years old;
- •The patient or family member agrees to sign the informed consent.
排除标准
- •Hematoma is caused by secondary factors (intracranial tumor, arteriovenous malformation or aneurysm);
- •Bleeding into the ventricle;
- •Multiple cerebral hemorrhage;
- •The patient did not receive treatment in our hospital;
- •Severe disability, dementia, or organ dysfunction before onset
- •Coagulopathy or long-term use of anticoagulants
- •Hematoma affects brain stem
- •Subjects refused to participate
结局指标
主要结局
The type and content of circulating exosomes
时间窗: within 24 hours of ICH
After the exosomes were isolated, RNA sequencing and proteome sequencing were performed to identify the change of circulating exosomes
Modified Rankin scale (mRS) scores
时间窗: from onset to three months or six months
mRS scores was divided into seven grades (0-6). The higher the score, the more severe the symptoms
次要结局
- mortality(through study completion，an average of 1 year)
- hospital stay(From hospitalization to discharge，up to one month)
研究者
研究点 (1)
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