Clinical trial NCT05108909: Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury
Official title: Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MTBI - Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury
Keywords: mild to moderate traumatic brain injury
biomarkers
magnetic resonance image
CT
diagnosis
Prognostic identification
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Central South University
name: Xijing Hospital
First posted: 2021-11-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: TBI patients will be recruited from the emergency department of hospital.

Brief summary: The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Detailed description: Traumatic brain injury (TBI) is a complex disorder that comprises a spectrum of intracranial pathologies, many of which present diagnostic challenges. Detection of intracranial injuries after TBI relies on head CT, which is overused and resource intensive. Prior studies have shown the potential for blood-based brain injury biomarkers to predict the absence of intracranial injury after TBI and aid in reducing unnecessary head CT use. Furthermore, plasma biomarker concentrations in the acute phase after TBI identified patients with a suspected TBI and normal head CT who had detectable pathology on MRI. However, most of the current studies are based on the European and American population, and whether the research results are applicable to the Chinese population remains to be studied. Therefore, the investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Eligibility criteria: Inclusion Criteria:

* age 18-75 years at time of recruitment.
* Glasgow Coma Scale (GCS) score of 9-15 at the time of informed consent.
* non-penetrating TBI resulting from an external force.
* diagnosed within 1 week after onset of TBI.
* provision of informed written consent.

Exclusion Criteria:

* acute suspected stroke, neurosurgery, stroke or TIA within the last 30 days.
* neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors.
* a history of a previous brain injury, or a history of concurrent substance or alcohol abuse;
* the manifestation of TBI caused by medications, alcohol, drugs for other injuries (such as systemic injuries, facial injuries, or intubation).
* pregnancy or breastfeeding.
* Patients with contraindications to MRI scanning (such as patients with metal implants in their bodies, cardiac pacemakers, dentures, etc.)
* participation in a clinical research study with potential to affect the results of this study

Primary outcomes:
measure: The concentration of serum biomarkers.
timeFrame: baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.
measure: Score of Extended Glasgow Outcome Scale.
timeFrame: post-traumatic for 3 months
measure: Score of Extended Glasgow Outcome Scale.
timeFrame: post-traumatic for 6 months
measure: Score of Extended Glasgow Outcome Scale.
timeFrame: post-traumatic for 12 months
measure: Number of participants with positive head CT scan
timeFrame: baseline (early injury)
measure: Number of participants with MRI abnormalities
timeFrame: baseline (early injury)
Secondary outcomes:
measure: Change from baseline brain structure measures at 3 months
timeFrame: baseline (early injury), post-traumatic for 3 months.
measure: Change from baseline brain structure measures at 6 months
timeFrame: baseline (early injury), post-traumatic for 6 months.
measure: Change from baseline brain structure measures at 12 months
timeFrame: baseline (early injury), post-traumatic for 12 months.
measure: White matter integrity at baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
timeFrame: baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Ming Zhang, phD
role: PRINCIPAL_INVESTIGATOR
References: