Study protocol for investigating the clinical performance of an automated blood test for glial fibrillary acidic protein and ubiquitin carboxy-terminal hydrolase L1 blood concentrations in elderly patients with mild traumatic BRAIN Injury and reference values (BRAINI-2 Elderly European study): a prospective multicentre observational study

Autor: Vincent Sapin, Jean-François Payen, Javier de la Cruz, Alfonso Lagares, Juan Sahuquillo, Marion Douplat, Laurent Jacquin, Odile Mejan, Vladislav Pavlov, Julian Morales, Maite Cuesta, Tamara Garcia, Peter Biberthaler, M Antonia Poca, Damien Viglino, Aurora Lassaletta, Ana María Castaño–León, Andreea Baciu, Monica Maldonado, Guillermo García Posadas, Olga Esteban, Luis Miguel Moreno, Elena Salvador, Elena Sanchez Trillo, Mercedes García Gámiz, Alejandro Yañez Anchústegui, Jorge Sánchez-Tembleque Sánchez, Joliette Maybe Martínez Barquero Santelices, Jose A Fernández Alén, Guillermo Blasco García de Andoain, Davide Luordo, Francisco García Sánchez, Sergio Gámez Diez, Gonzalo Latorre Barcenilla, Juan Antonio Blanco Cabello, Maria Elena Pacios, Katiusca Rosas, Helena Calvo, Diego López–Bermeo, Andrés Cabrera, Margarita Figueroa, Judith Sánchez–Raya, Ana León, Eladi–Madalina Petriman, Noelia Montoya, Marta Peris, Paula Duch, Angel Sánchez-Mancheño, Aasma Sahuquillo, Juan Perez Barcena, Maria Clara Pascual, Jean baptiste Bouillon
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMJ Open, Vol 13, Iss 7 (2023)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2022-071467
Popis: 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
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