BLOOD BIOMARKERS in PAEDIATRIC MTBI

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT06233851
• Lead Sponsor: Pediatric Clinical Research Platform

Brief Summary

The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:

1. How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?

2. How can blood biomarker predict post-concussion symptoms?

Participants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.

Detailed Description

Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome.

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-01-31
• Primary Completion: 2024-06-10
• Study Completion: 2024-07-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• mTBI within 24 hours

Exclusion Criteria

• refusal of child or parents
• evidence of intoxication with alcohol or other substances
• history of TBI ( less than one month)
• epilepsy, encephalitis, meningitis, melanoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intracranial injuries on CT scan	Admission; within 24 hours	Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus
Post concussion symptoms	3 months	Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)

Trial Locations

Locations (1)

HUG; 🇨🇭 Geneve, Switzerland