PMID- 33632753
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 2
DP  - 2021 Feb 25
TI  - 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.
PG  - e043635
LID - 10.1136/bmjopen-2020-043635 [doi]
LID - e043635
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published 
      by BMJ.
FAU - Richard, Marion
AU  - Richard M
AD  - Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre 
      Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, 
      INSERM, U1216, Grenoble, France.
FAU - Lagares, Alfonso
AU  - Lagares A
AUID- ORCID: 0000-0003-3996-0554
AD  - Servicio de Neurocirugia, Hospital Universitario 12 de Octubre, Universidad 
      Complutense de Madrid, Instituto de Investigacion imas12, Madrid, Spain 
      alfonlag@ucm.es.
FAU - Bondanese, Victor
AU  - Bondanese V
AD  - bioMerieux, Clinical Unit, Chemin de l'Orme, Marcy l'Etoile, Spain.
FAU - de la Cruz, Javier
AU  - de la Cruz J
AD  - Instituto de Investigacion imas12, Hospital Universitario 12 de Octubre, SAMID, 
      Madrid, France.
FAU - Mejan, Odile
AU  - Mejan O
AD  - bioMerieux, Clinical Unit, Chemin de l'Orme, Marcy l'Etoile, Spain.
FAU - Pavlov, Vladislav
AU  - Pavlov V
AD  - bioMerieux, Medical Affairs, Chemin de l'Orme, Marcy-l'Etoile, France.
FAU - Payen, Jean-Francois
AU  - Payen JF
AD  - Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre 
      Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, 
      INSERM, U1216, Grenoble, France.
CN  - BRAINI investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT04032509
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210225
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Biomarkers)
RN  - EC 3.4.19.12 (Ubiquitin Thiolesterase)
SB  - IM
MH  - Adult
MH  - Biomarkers
MH  - *Brain Concussion/diagnostic imaging
MH  - *Brain Injuries, Traumatic/diagnostic imaging
MH  - France
MH  - Hematologic Tests
MH  - Humans
MH  - Observational Studies as Topic
MH  - Prospective Studies
MH  - Quality of Life
MH  - Spain
MH  - Ubiquitin Thiolesterase
PMC - PMC7908910
OTO - NOTNLM
OT  - accident & emergency medicine
OT  - computed tomography
OT  - neurosurgery
OT  - trauma management
COIS- Competing interests: VB, OM and VP are employees of bioMerieux.
FIR - Maignan, Maxime
IR  - Maignan M
FIR - Jacquin, Laurent
IR  - Jacquin L
FIR - Douplat, Marion
IR  - Douplat M
FIR - Laribi, Said
IR  - Laribi S
FIR - Pes, Philippe
IR  - Pes P
FIR - Ray, Patrick
IR  - Ray P
FIR - Guenezan, Jeremy
IR  - Guenezan J
FIR - Sebbane, Mustapha
IR  - Sebbane M
FIR - Balen, Frederic
IR  - Balen F
FIR - Durand, Guillaume
IR  - Durand G
FIR - Abric, Cordelia
IR  - Abric C
FIR - Gil-Jardine, Cedric
IR  - Gil-Jardine C
FIR - Mihai, Podaru
IR  - Mihai P
FIR - Morales, Julian
IR  - Morales J
FIR - Castuera, Ana
IR  - Castuera A
FIR - Garcia Ponce, Mariana
IR  - Garcia Ponce M
FIR - Cuesta, Maite
IR  - Cuesta M
FIR - Alen, Jose A F
IR  - Alen JAF
EDAT- 2021/02/27 06:00
MHDA- 2021/05/15 06:00
PMCR- 2021/02/25
CRDT- 2021/02/26 05:53
PHST- 2021/02/26 05:53 [entrez]
PHST- 2021/02/27 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2021/02/25 00:00 [pmc-release]
AID - bmjopen-2020-043635 [pii]
AID - 10.1136/bmjopen-2020-043635 [doi]
PST - epublish
SO  - BMJ Open. 2021 Feb 25;11(2):e043635. doi: 10.1136/bmjopen-2020-043635.