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Clinical Trials/NCT05778123
NCT05778123
Recruiting
Not Applicable

Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

RenJi Hospital1 site in 1 country10 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
RenJi Hospital
Enrollment
10
Locations
1
Primary Endpoint
Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Junfeng Feng

Director of Brain Injury Center

RenJi Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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