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Clinical Trials/NCT05867992
NCT05867992
Not yet recruiting
Not Applicable

Proteomic and Metabolomic Detection and Analysis of Serum From Patients With Acute Severe Traumatic Brain Injury: A Prospective, Multicentered Study

RenJi Hospital1 site in 1 country80 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
RenJi Hospital
Enrollment
80
Locations
1
Primary Endpoint
Number of differently expressed proteins in patients' serum detected by proteomic
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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:

  1. Which proteins and metabolites are differently expressed in TBI patients' serum?
  2. 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.

Detailed Description

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: 1. Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI) 2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
June 30, 2025
Last Updated
2 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

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Number of differently expressed proteins in patients' serum detected by proteomic

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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