NCT05413499: BRAINI2

Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury

Status unknown NA Last updated 24 August 2022

What this trial tests

NA trial testing Biomarkers research in Traumatic Brain Injury in 2,880 participants. Status unknown.

Timeline

2 August 2022

Primary endpoint
1 January 2025

1 April 2025

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	2,880
Start date	2 August 2022
Primary completion	1 January 2025
Estimated completion	1 April 2025
Sites	20 locations across France, Switzerland, Germany, Spain

Drugs / interventions tested

• Biomarkers research

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

Nantes University Hospital

Who can join

Adults 0 Days to 18, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4).

Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms.

One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Performance of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) biomarkers in predicting CT scan results and neurological outcomes in children with traumatic brain injury (BRAINI-2 paediatric study): protocol of a European prospective mu
   Lorton F, Lagares A, de la Cruz J, Méjan O, et al · · 2024 · cited 4× · PMID 38754888 · DOI 10.1136/bmjopen-2023-083531