NCT05867992

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. 1.Which proteins and metabolites are differently expressed in TBI patients' serum?
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 5, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

May 2, 2023

Last Update Submit

September 1, 2024

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injuryBiomarkerMultiomic analysisDiagnosis

Outcome Measures

Primary Outcomes (2)

  • Number of differently expressed proteins in patients' serum detected by proteomic

    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.

    First 12 hours in the emergency room

  • Number of differently expressed metabolites in patients' serum detected by metabolomic

    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.

    First 12 hours in the emergency room

Study Arms (2)

Case group

This group enrolls patients with acute severe traumatic brain injury.

Other: Type of trauma

Control group

This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury.

Other: Type of trauma

Interventions

Type of traumaOTHER

Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.

Case groupControl group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 201114, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples from patients with acute severe traumatic brain injury.

MeSH Terms

Conditions

Brain Injuries, TraumaticDisease

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Junfeng Feng, Ph.D.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenghui He, M.D.

CONTACT

+8613585916217hezhenghui8@qq.com

Weiji Weng, Ph.D.

CONTACT

+8613916673435zigzagweng@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Brain Injury Center

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 22, 2023

Study Start

June 1, 2024

Primary Completion

May 31, 2025

Study Completion

December 31, 2025

Last Updated

September 5, 2024

Record last verified: 2024-01

Locations

CN(1)