Clinical trial NCT03976492: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
First posted: 2019-06-06
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal population, patients with brain injury within 24h combined with or without systemtic injuries.

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.


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.

Primary outcomes:
measure: Protein levels of GFAP、UCH-L1、H-FABP、Aβ40、Aβ42、IL-10、NF-L、S100B and tau
timeFrame: One year
measure: Discovery of metabolic biomarkers in plasma that will lead to the early detection of traumatic brain injury
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References: