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Clinical Trials/NCT03976492
NCT03976492
Recruiting
Not Applicable

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

Baiyun Liu1 site in 1 country450 target enrollmentDecember 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Baiyun Liu
Enrollment
450
Locations
1
Primary Endpoint
Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 31, 2020
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Baiyun Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Baiyun Liu

professor

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

  • Male and Female, aged from 18 to
  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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