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临床试验/NCT05778123
NCT05778123招募中不适用

Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis

研究概览

简要总结

The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:

  • Which RNA, protein and metabolites are differently expressed in lesion tissues?
  • What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 and <65
  • Within 12 hours after brain injury
  • Control group is hydrocephalus
  • GCS ≥3 and ≤8
  • Closed brain injury with frontotemporal contusion
  • Need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation
  • Patient's agents are informed and consent the research

排除标准

  • With TBI, stroke, ICH or intracranial tumor history
  • Death within 24 hours
  • Immunosuppression state
  • Severe organ dysfunction
  • Complicated infective disease

结局指标

主要结局

Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis

时间窗: Immediately after collecting blood & cerebrospinal fluid

Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to 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 blood and cerebrospinal fluid of severe TBI patients.

RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis

时间窗: Immediately after collecting blood & cerebrospinal fluid

Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through transcriptome sequencing. The results of transcriptome sequencing will be further analyzed and compared with control group to filter potential RNA biomarkers in blood and cerebrospinal fluid of severe TBI patients.

Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis

时间窗: Immediately after collecting blood & cerebrospinal fluid

Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through proteomics mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in blood and cerebrospinal fluid of severe TBI patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junfeng Feng

Director of Brain Injury Center

RenJi Hospital

研究点 (1)

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