Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-02 @ 7:46 AM
Study NCT ID:
NCT05867992
Status:
RECRUITING
Last Update Posted:
2024-09-05
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MASTER-TBI
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.
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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: