{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T22:29:40Z","timestamp":1781821780714,"version":"3.54.5"},"reference-count":25,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2021,2,25]],"date-time":"2021-02-25T00:00:00Z","timestamp":1614211200000},"content-version":"unspecified","delay-in-days":24,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,1,25]]},"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>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\u201315 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\u2009week and 3 months after the trauma.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>ClinicalTrials.gov:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04032509\">NCT04032509<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2020-043635","type":"journal-article","created":{"date-parts":[[2021,2,25]],"date-time":"2021-02-25T16:59:51Z","timestamp":1614272391000},"page":"e043635","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":18,"title":["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"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04032509","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct03280485","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Marion","family":"Richard","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3996-0554","authenticated-orcid":false,"given":"Alfonso","family":"Lagares","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Bondanese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"de la Cruz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Odile","family":"Mejan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladislav","family":"Pavlov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Fran\u00e7ois","family":"Payen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,2,25]]},"reference":[{"key":"2024101905112973000_11.2.e043635.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)93219-8"},{"key":"2024101905112973000_11.2.e043635.2","doi-asserted-by":"crossref","first-page":"506","DOI":"10.1016\/S1474-4422(15)00002-2","article-title":"Diagnosis, prognosis, and clinical management of mild traumatic brain injury","volume":"14","author":"Levin","year":"2015","journal-title":"Lancet Neurol"},{"key":"2024101905112973000_11.2.e043635.3","first-page":"351","article-title":"Mild head injury in adults a review","volume":"11","author":"Gomez","year":"2000","journal-title":"Neurocirugia"},{"key":"2024101905112973000_11.2.e043635.4","doi-asserted-by":"publisher","DOI":"10.1080\/02688699647078"},{"key":"2024101905112973000_11.2.e043635.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200007133430204"},{"key":"2024101905112973000_11.2.e043635.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)04561-X"},{"key":"2024101905112973000_11.2.e043635.7","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1007\/s13341-012-0202-4","article-title":"Traumatisme cr\u00e2nien l\u00e9ger (score de Glasgow de 13 \u00e0 15) : triage, \u00e9valuation, examens compl\u00e9mentaires et prise en charge pr\u00e9coce chez le nouveau-n\u00e9, l\u2019enfant et l\u2019adulte","volume":"2","author":"Jehl\u00e9","year":"2012","journal-title":"Ann Fr Med Urgence"},{"key":"2024101905112973000_11.2.e043635.8","first-page":"483","article-title":"CT overuse for mild traumatic brain injury","volume":"38","author":"Melnick","year":"2012","journal-title":"Jt Comm J Qual Patient Saf"},{"key":"2024101905112973000_11.2.e043635.9","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-11-50"},{"key":"2024101905112973000_11.2.e043635.10","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1001\/jamaneurol.2016.0039","article-title":"Time course and diagnostic accuracy of glial and neuronal blood biomarkers GFAP and UCH-L1 in a large cohort of trauma patients with and without mild traumatic brain injury","volume":"73","author":"Papa","year":"2016","journal-title":"JAMA Neurol"},{"key":"2024101905112973000_11.2.e043635.11","doi-asserted-by":"publisher","DOI":"10.1089\/neu.2013.3040"},{"key":"2024101905112973000_11.2.e043635.12","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(18)30231-X"},{"key":"2024101905112973000_11.2.e043635.13","unstructured":"Banyan BTI\u2122 . 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