Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Interventions
- Other: Type of trauma
- Registration Number
- NCT05867992
- Lead Sponsor
- RenJi Hospital
- 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)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case group Type of trauma This group enrolls patients with acute severe traumatic brain injury. Control group Type of trauma This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury.
- Primary Outcome Measures
Name Time Method Number of differently expressed proteins in patients' serum detected by proteomic 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China