Application of Circulating Extracellular Vesicles in Early Disease Assessment and Prognosis After Traumatic Brain Injury
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
- Neurological deterioration in patients with traumatic brain injury
研究概览
简要总结
The purpose of this study was to observe the relationship between the changes of circulating extracellular vesicles and disease development and outcome in patients with traumatic brain injury, and to find early serum markers and potential intervention targets for disease monitoring in patients with traumatic brain injury. In addition, explore the source of extracellular vesicles as much as possible to prepare for subsequent basic experiments.
详细描述
To compare the changes of molecular markers and circulating-related cell phenotype molecules in the serum of patients with traumatic brain injury, to observe the relationship between the changes of circulating extracellular vesicles and the development and outcome of the disease in patients with traumatic brain injury, and to search for early serum markers of patients with traumatic brain injury and potential interventions.
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 before admission;
- •The patient is diagnosed with traumatic brain injury with imaging evidence;
- •Age > 18 years old;
- •The patient or family members agree to sign the informed consent.
排除标准
- •Infectious diseases within the past 1 month;
- •Past head trauma, history of neurological diseases;
- •Non-isolated traumatic brain injury;
- •The patient is not receiving treatment in this hospital;
- •Severe disability, dementia, or organ dysfunction before the onset of the disease;
- •Subject refuses to participate.
结局指标
主要结局
Neurological deterioration in patients with traumatic brain injury
时间窗: within 7 days after injury
Neurological deterioration (ND) was defined as the occurrence of one or more of the following criteria within 7 days after injury: (a) a decrease in GCS score of 2 points or more from the initial GCS score with no pharmacological sedation; (b) a deterioration in neurological status being sufficient to neurosurgical intervention.
The type and content of circulating extracellular vesicles
时间窗: within 24 hours of TBI
After isolation of circulating extracellular vesicles, RNA sequencing was performed to determine noncoding RNA changes in circulating extracellular vesicles. Screening criteria were based on logFC and P value, generally with \|logFC\|\>2 and AP value \<0.05 to define whether there was a difference.
次要结局
- GOSE score(three months or six months)
- hospital stay(From hospitalization to discharge，up to one month)