NCT05413499

Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury

BRAINI2-Paediatric : Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury: a European, Prospective, Multicentre Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,880 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Biomarkers research	For a part of the included population, the children with a mTBI and without indication of CT scan, a non-routine blood sample will be planned

Timeline

• Start date: 2022-08-02
• Primary completion: 2025-01-01
• Completion: 2025-04-01
• First posted: 2022-06-10
• Last updated: 2022-08-24

Locations

20 sites across 4 countries: France, Germany, Spain, Switzerland