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

Recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Diagnostic Test: diagnostic of specific biomarkers

• Registration Number: NCT03976492
• Lead Sponsor: Baiyun Liu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2020-12-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain injury group	diagnostic of specific biomarkers	patients with traumatic brain injury within 24 hours
Non-brain injury group	diagnostic of specific biomarkers	Non-brain injury group refers to patients with limb injury or systemic injury except brain injury.

Primary Outcome Measures

Name	Time	Method
Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury	One year	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.
Protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tau	One year	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China