AI Article Synopsis
- Two blood biomarkers, GFAP and UCH-L1, are being studied for their ability to indicate if elderly patients with mild traumatic brain injury (mTBI) have intracranial lesions, particularly when tested within the first 12 hours.
- The study involves a large cohort of over 2,300 elderly patients with mTBI and aims to evaluate the effectiveness of an automated test to predict brain CT scan outcomes, and establish reference values for these biomarkers in a non-TBI elderly population.
- Ethical approval has been secured for the research, and results will be shared at scientific meetings in the future.*
Article Abstract
Introduction: Two blood brain-derived biomarkers, glial fibrillar acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), can rule out intracranial lesions in patients with mild traumatic brain injury (mTBI) when assessed within the first 12 hours. Most elderly patients were excluded from previous studies due to comorbidities. Biomarker use in elderly population could be affected by increased basal levels. This study will assess the performance of an automated test for measuring serum GFAP and UCH-L1 in elderly patients to predict the absence of intracranial lesions on head CT scans after mTBI, and determine both biomarkers reference values in a non-TBI elderly population.
Methods And Analysis: This is a prospective multicentre observational study on elderly patients (≥65 years) that will be performed in Spain, France and Germany. Two patient groups will be included in two independent substudies. (1) A cohort of 2370 elderly patients (1185<80 years and 1185≥80 years; BRAINI2-ELDERLY DIAGNOSTIC AND PROGNOSTIC STUDY) with mTBI and a brain CT scan that will undergo blood sampling within 12 hours after mTBI. The primary outcome measure is the diagnostic performance of GFAP and UCH-L1 measured using an automated assay for discriminating between patients with positive and negative findings on brain CT scans. Secondary outcome measures include the performance of both biomarkers in predicting early (1 week) and midterm (3 months) neurological status and quality of life after trauma. (2) A cohort of 480 elderly reference participants (BRAINI2-ELDERLY REFERENCE STUDY) in whom reference values for GFAP and UCHL1 will be determined.
Ethics And Dissemination: Ethical approval was obtained from the Institutional Review Boards of Hospital 12 de Octubre in Spain (Re#22/027) and Southeast VI (Clermont Ferrand Hospital) (Re# 22.01782.000095) in France. The study's results will be presented at scientific meetings and published in peer-review publications.
Trial Registration Number: NCT05425251.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10357305 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2022-071467 | DOI Listing |
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