Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Proteomic and Metabolomic Detection and Analysis of Serum From Patients With Acute Severe Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: Type of trauma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With traumatic brain injury in 12Hrs for case group, or with traumatic bone fracture in 12Hrs 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 24Hrs. Immunosuppressed state. Severe multiple organ dysfunction. With infection. Pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>This group enrolls patients with acute severe traumatic brain injury. | Other: Type of trauma<br>* Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.<br>|
| Control group<br>This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury. | Other: Type of trauma<br>* Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of differently expressed proteins in patients' serum detected by proteomic | 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. | First 12Hr in the emergency room | 
| Number of differently expressed metabolites in patients' serum detected by metabolomic | 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. | First 12Hr in the emergency room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, Biomarker, Multiomic analysis, Diagnosis