Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
NCT ID: NCT05867992
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2024-06-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Case group
This group enrolls patients with acute severe traumatic brain injury.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Junfeng Feng
Director of Brain Injury Center
Principal Investigators
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Junfeng Feng, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Junfeng Feng, Ph.D.
Role: backup
Jiyuan Hui, Ph.D.
Role: backup
Ru Gong, Ph.D.
Role: backup
Weiji Weng, Ph.D.
Role: backup
Weiyuan Xiao, Ph.D.
Role: backup
Other Identifiers
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LY2024-006
Identifier Type: -
Identifier Source: org_study_id
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