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OpenTrials
Completed

NCT Number: NCT06233851

BLOOD BIOMARKERS in PAEDIATRIC MTBI

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. intracranial injuries on CT scan

    Time frame: Admission; within 24 hours

    Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus

  2. Post concussion symptoms

    Time frame: 3 months

    Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)

Sponsors and collaborators

Lead sponsor

Pediatric Clinical Research Platform

Other

Registry information

Official study title

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

Acronym: t-BIOMAP

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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