Clinical trial NCT05867992: Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
Official title: Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Biomarker
Multiomic analysis
Diagnosis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the case group are these with brain injury, caused by trauma and are severe (GCS 3-8) and in acute period (within 12 hours). Meanwhile, these patients should not have acute bone fracture or other orthopaedic diseases, to avoid any biological detecting bias to control group.

Patients in the control group are these with bone fracture, caused by trauma and in acute period (within 12 hours). Also, these patients should not have acute brain injury or other neurological diseases to avoid the same bias in biological detection.

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)

Eligibility criteria: Inclusion Criteria:

* With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs 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.

Primary outcomes:
measure: Number of differently expressed proteins in patients' serum detected by proteomic
timeFrame: First 12 hours in the emergency room
measure: Number of differently expressed metabolites in patients' serum detected by metabolomic
timeFrame: First 12 hours in the emergency room
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Junfeng Feng, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: