Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH-L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study
Open Access
- 25 February 2021
- Vol. 11 (2), e043635
- https://doi.org/10.1136/bmjopen-2020-043635
Abstract
Introduction Mild traumatic brain injury (mTBI) is a common cause of clinical consultation in the emergency department. Patients with mTBI may undergo brain CT scans based on clinical criteria. However, the proportion of patients with brain lesions on CT is very low. Two serum biomarkers, glial fibrillar acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), have been shown to discriminate patients regarding the presence or absence of brain lesions on initial CT scan when assessed within the first 12 hours after TBI. However, the current technique for measuring serum concentrations of GFAP and UCH-L1 is manual and time consuming, which may hinder its use in routine clinical practice. This study assesses the diagnostic accuracy of an automated assay for the measurement of serum GFAP and UCH-L1 in a cohort of patients with mTBI who received a CT scan as the standard of care. Methods and analysis This is a prospective multicentre observational study of 1760 patients with mTBI recruited in France and Spain across 16 participating sites. Adult patients with an initial Glasgow Coma Scale score of 13–15 and a brain CT scan underwent blood sampling within 12 hours after TBI. The primary outcome measure is the diagnostic performance of an automated assay measuring serum concentrations of GFAP and UCH-L1 for discriminating between patients with positive and negative findings on brain CT-scans. Secondary outcome measures include the performance of these two biomarkers in predicting the neurological status and quality of life at 1 week and 3 months after the trauma. Ethics and dissemination Ethics approval was obtained by the Institutional Review Board of Sud-Ouest Outre Mer III in France (Re#2019-A01525-52) and Hospital 12 de Octubre in Spain (Re#19/322). The results will be presented at scientific meetings and published in peer-reviewed publications. Trial registration number ClinicalTrials.gov: NCT04032509.Keywords
This publication has 24 references indexed in Scilit:
- Acute Biomarkers of Traumatic Brain Injury: Relationship between Plasma Levels of Ubiquitin C-Terminal Hydrolase-L1 and Glial Fibrillary Acidic ProteinJournal of Neurotrauma, 2014
- Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults: an evidence and consensus-based updateBMC Medicine, 2013
- Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)Quality of Life Research, 2011
- Quality of Life after Brain Injury (QOLIBRI): Scale Validity and Correlates of Quality of LifeJournal of Neurotrauma, 2010
- Indications for Computed Tomography in Patients with Minor Head InjuryThe New England Journal of Medicine, 2000
- Structured Interviews for the Glasgow Outcome Scale and the Extended Glasgow Outcome Scale: Guidelines for Their UseJournal of Neurotrauma, 1998
- Analyzing Outcome of Treatment of Severe Head Injury: A Review and Update on Advancing the Use of the Glasgow Outcome ScaleJournal of Neurotrauma, 1998
- Mild head injury: differences in prognosis among patients with a Glasgow Coma Scale score of 13 to 15 and analysis of factors associated with abnormal CT findingsBritish Journal of Neurosurgery, 1996
- The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliabilityZeitschrift für Neurologie, 1995
- ASSESSMENT OF COMA AND IMPAIRED CONSCIOUSNESS: A Practical ScaleThe Lancet, 1974