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

NCT03976492 | Unknown

• 1 other identifier: BTHospital KY2019-012-04
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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.

  One year

• 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.

  One year

Study Arms (3)

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 of specific biomarkers DIAGNOSTIC_TEST

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.

Brain injury group; Non-brain injury group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baiyun Liu: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Fei Niu

CONTACT

+86-18701075929; nf520621@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: December 31, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)