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RecruitingNCT03976492Updated Aug 8, 2023

The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury

An observational study in Traumatic Brain Injury, sponsored by Baiyun Liu. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by Baiyun Liu · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2020; still recruiting 5 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
450
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Traumatic brain injury (TBI) is the most common type of nerve injury and it severely endangers the public health. It is necessary to accurately measure the early neurological function of brain injury for monitoring its prognosis and therapeutic interventions. Glasgow Coma Score (GCS) and Computed Tomography (CT) are often used to diagnose the severity of TBI. However, GCS has its drawbacks in the observation of prognosis, because it is interfered by analgesics, sedatives and relaxants in the evaluation of neurological function. CT may miss the diagnosis of diffuse axonal injury (DAI) and the monitoring of intracranial pressure (ICP). Secondary injuries after TBI, such as oxidative stress, inflammatory damage, and abnormal metabolism, can destroy cerebral blood vessels and structures, which also affect the diagnosis of injury. Therefore, there is an urgent need for new methods to quickly identify which patients are likely to suffer brain injury or even cause persistent disability. Detection of brain injury biomarkers based on blood and brain tissue has long been used to assess the severity of TBI, but no biomarkers have been found for early diagnosis of mTBI and prognosis of different degrees of brain injury. Protein and metabolic product differences were detected from blood or the lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform, and diagnostic markers of potential traumatic brain injury were found, and their differential and diagnostic values were discussed.

02

Conditions studied

03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 450 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Baiyun Liu is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

normal population, patients with brain injury within 24h combined with or without systemtic injuries.

Inclusion criteria

  1. Male and Female, aged from 18 to 65.
  2. Patients with brain injury within 24 hours after injury
  3. Non-brain injury group refers to patients with limb injury or systemic injury except brain injury.
  4. The subject reads and fully understands the instructions of the patients and signs the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Male or female, aged below 18.
  2. Patients with definite history of central nervous system or cardiovascular system or taking drugs affecting the central nervous system.
  3. Patients with severe metabolic diseases.
  4. Pregnancy.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normal group

    normal population

  • Brain injury group

    patients with traumatic brain injury within 24 hours

    Diagnostic Test: diagnostic of specific biomarkers

  • Non-brain injury group

    Non-brain injury group refers to patients with limb injury or systemic injury except brain injury.

    Diagnostic Test: diagnostic of specific biomarkers

Interventions

  • Diagnostic testdiagnostic of specific biomarkers

    Protein and metabolic product differences will be detected from blood or lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform. Diagnostic markers of potential traumatic brain injury will be found, and their differential diagnostic values were discussed.

06

What researchers measure

Primary outcomes

  1. Protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tau

    The difference protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tau assessed by the proteomics of the one year after traumatic brain injury.

    Time frame: One year

  2. Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury

    Metabolic biomarkers in plasma, such as methionine、glycine、cysteine、gamma-glutamylleucine、5-oxoproline、alpha-ketobutyrate、2-hydroxybutyrate, etal.. assessed by the metabolomics of the one year after traumatic brain injury.

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
    • Xiang Mao · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Published in the form of an article after the completion of the trail.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03976492
Lead sponsor
Baiyun Liu
Collaborators
The First Affiliated Hospital of Anhui Medical University
Responsible party
Baiyun Liu (professor, Beijing Tiantan Hospital) — Sponsor-investigator
First posted
Jun 6, 2019
Start date
Dec 31, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 8, 2023

Study contacts

Fei Niu
Contact
nf520621@163.com
+86-18701075929

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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