MASTER-TBI: Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05867992

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Other: Type of trauma

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:

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Case group

This group enrolls patients with acute severe traumatic brain injury.

Other: Type of trauma

Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.

Control group

This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury.

Other: Type of trauma

Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.

Outcome Measures

Primary Outcome Measures

Number of differently expressed proteins in patients' serum detected by proteomic [First 12Hr 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 [First 12Hr 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.