t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI

Mild Traumatic Brain Injury Clinical Trial

— t-BIOMAP  

Official title:

Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233851
• Other study ID #: 2020-01533
• Status: Recruiting
• Start date: October 6, 2020
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Pediatric Clinical Research Platform
• Contact: Anne-Cécile CHIOLLAZ, PharmD
• Phone: +41223795894
• Email: anne-cecile.chiollaz[@]unige.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Locations

Country	Name	City	State
Switzerland	HUG	Geneve

Sponsors (1)

Lead Sponsor	Collaborator
Pediatric Clinical Research Platform

Country where clinical trial is conducted

Switzerland, 

Outcome

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