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出境医 / 临床实验 / 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

Study Description
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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Diagnostic Test: diagnostic of specific biomarkers

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Normal group
normal population
Brain injury group
patients with traumatic brain injury within 24 hours
Diagnostic Test: diagnostic 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.

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
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.

Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Fei Niu +86-18701075929 nf520621@163.com

Locations
Layout table for location information
China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China
Contact: Xiang Mao         
Sponsors and Collaborators
Baiyun Liu
The First Affiliated Hospital of Anhui Medical University
Tracking Information
First Submitted Date June 3, 2019
First Posted Date June 6, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date June 4, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury
Official Title The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population normal population, patients with brain injury within 24h combined with or without systemtic injuries.
Condition Traumatic Brain Injury
Intervention Diagnostic Test: diagnostic 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.
Study Groups/Cohorts
  • Normal group
    normal population
  • Brain injury group
    patients with traumatic brain injury within 24 hours
    Intervention: 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.
    Intervention: Diagnostic Test: diagnostic of specific biomarkers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2019)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Fei Niu +86-18701075929 nf520621@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03976492
Other Study ID Numbers BTHospital KY2019-012-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Published in the form of an article after the completion of the trail.
Responsible Party Baiyun Liu, Beijing Tiantan Hospital
Study Sponsor Baiyun Liu
Collaborators The First Affiliated Hospital of Anhui Medical University
Investigators Not Provided
PRS Account Beijing Tiantan Hospital
Verification Date June 2020