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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03976492
Enrollment
450
Registered
2019-06-06
Start date
2020-12-31
Completion date
2023-12-31
Last updated
2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief 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.

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.

Sponsors

The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
Baiyun Liu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tauOne yearThe 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.
Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injuryOne yearMetabolic 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.

Countries

China

Contacts

Primary ContactFei Niu
nf520621@163.com+86-18701075929

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026