Proteomic and Metabolomic Detection and Analysis of Serum From Patients With Acute Severe Traumatic Brain Injury: A Prospective, Multicentered Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of differently expressed proteins in patients' serum detected by proteomic
研究概览
简要总结
The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:
- Which proteins and metabolites are differently expressed in TBI patients' serum?
- Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.
详细描述
This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.
Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:
- Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)
- Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With traumatic brain injury in 12Hrs for case group, or with traumatic bone fracture in 12 hours for control group.
- •The Glasglow Coma Scale ranges in 3-8 for case group.
- •Need to have routine laboratory examination of blood sample.
- •Patients or agents sign the informed consent.
排除标准
- •With bone fracture for case group, or with brain injury for control group.
- •Have Orthopaedic history for case group, or have Neurological history for control group.
- •Death in 24 hours.
- •Immunosuppressed state.
- •Severe multiple organ dysfunction.
- •With infection.
- •Pregnant.
结局指标
主要结局
Number of differently expressed proteins in patients' serum detected by proteomic
时间窗: First 12 hours in the emergency room
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through proteomic mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in serum of severe TBI patients in acute phase.
Number of differently expressed metabolites in patients' serum detected by metabolomic
时间窗: First 12 hours in the emergency room
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in serum of severe TBI patients in acute phase.
次要结局
未报告次要终点
研究者
Junfeng Feng
Director of Brain Injury Center
RenJi Hospital