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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976492
• Other study ID #: BTHospital KY2019-012-04
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Beijing Tiantan Hospital
• Contact: Fei Niu
• Phone: +86-18701075929
• Email: nf520621[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
Baiyun Liu	The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein levels of GFAP?UCH-L1?H-FABP?Aß40?Aß42?IL-10?NF-L?S100B and tau	The difference protein levels of GFAP?UCH-L1?H-FABP?Aß40?Aß42?IL-10?NF-L?S100B and tau assessed by the proteomics of the one year after traumatic brain injury.	One year
Primary	Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury	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.	One year