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

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ClinicalTrials.gov Identifier: NCT03976492
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Baiyun Liu, Beijing Tiantan Hospital

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

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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
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal group
normal population
Brain injury group 1
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.

Brain injury group 2
patients with traumatic brain injury combined with systemic 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.

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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976492


Contacts
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Contact: Fei Niu +86 18701075929 nf520621@163.com

Sponsors and Collaborators
Baiyun Liu

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Responsible Party: Baiyun Liu, professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03976492     History of Changes
Other Study ID Numbers: BTHospital KY2019-012-03
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Published in the form of an article after the completion of the trail.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System