BMJ Open (Jul 2023)

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

  • ,
  • 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

DOI
https://doi.org/10.1136/bmjopen-2022-071467
Journal volume & issue
Vol. 13, no. 7

Abstract

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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.