Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

NCT ID: NCT05867992

Last Updated: 2024-09-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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)

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

This group enrolls patients with acute severe traumatic brain injury.

Type of trauma

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junfeng Feng

Director of Brain Injury Center

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenghui He, M.D.

Role: CONTACT

+8613585916217

Weiji Weng, Ph.D.

Role: CONTACT

+8613916673435

Facility Contacts

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Junfeng Feng, Ph.D.

Role: primary

+8613611860825

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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