NCT05778123

Brief Summary

The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:

  • Which RNA, protein and metabolites are differently expressed in lesion tissues?
  • What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

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

February 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

February 5, 2023

Last Update Submit

May 1, 2023

Conditions

Brain Injuries, Traumatic

Keywords

Traumatic brain injuryBody fluidBiomarkerMultiomic analysis

Outcome Measures

Primary Outcomes (3)

  • RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis

    Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through transcriptome sequencing. The results of transcriptome sequencing will be further analyzed and compared with control group to filter potential RNA biomarkers in blood and cerebrospinal fluid of severe TBI patients.

    Immediately after collecting blood & cerebrospinal fluid

  • Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis

    Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through proteomics mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in blood and cerebrospinal fluid of severe TBI patients.

    Immediately after collecting blood & cerebrospinal fluid

  • Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis

    Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to 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 blood and cerebrospinal fluid of severe TBI patients.

    Immediately after collecting blood & cerebrospinal fluid

Study Arms (2)

TBI

Patients with traumatic brain injury.

Other: Type of disease

Control

Patients with hydrocephalus.

Other: Type of disease

Interventions

Type of diseaseOTHER

Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.

ControlTBI

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe traumatic brain injury or hydrocephalus.

You may qualify if:

  • Age \>18 and \<65
  • Within 12 hours after brain injury
  • Control group is hydrocephalus
  • GCS ≥3 and ≤8
  • Closed brain injury with frontotemporal contusion
  • Need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation
  • Patient's agents are informed and consent the research

You may not qualify if:

  • With TBI, stroke, ICH or intracranial tumor history
  • Death within 24 hours
  • Immunosuppression state
  • Severe organ dysfunction
  • Complicated infective disease
  • 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, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Zhenghui He

CONTACT

+8613585916217hezhenghui8@hotmail.com

Study Design

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

Study Record Dates

First Submitted

February 5, 2023

First Posted

March 21, 2023

Study Start

April 1, 2023

Primary Completion

March 31, 2024

Study Completion

December 31, 2024

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)