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

• Sponsor: Baiyun Liu (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03976492
• Collaborator: The First Affiliated Hospital of Anhui Medical University (Other)
• Enrollment: 450
• Location: 1
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 14.6

Study Details

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	Phase
Traumatic Brain Injury	Diagnostic Test: diagnostic of specific biomarkers

Study Design

• Study Type: Observational
• Anticipated 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: Jun 4, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China

Sponsors and Collaborators

• Baiyun Liu
• The First Affiliated Hospital of Anhui Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baiyun Liu, professor, Beijing Tiantan Hospital
• ClinicalTrials.gov Identifier: NCT03976492
• Other Study ID Numbers: BTHospital KY2019-012-04
• First Posted: Jun 6, 2019
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries

Study Results

No Results Posted as of Jun 11, 2020