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

P

Pediatric Clinical Research Platform

Status

Enrolling

Conditions

Mild Traumatic Brain Injury

Study type

Observational

Funder types

Other

Identifiers

NCT06233851
2020-01533

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

mTBI patient
Description:
Children <16 years-old who suffered a head trauma in the last 24 hours with signs of mild traumatic brain injury
control
Description:
Children <16 years-old who have a scheduled blood test for any reason

Trial contacts and locations

1

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Central trial contact

Sergio Manzano, MD; Anne-Cécile CHIOLLAZ, PharmD

Data sourced from clinicaltrials.gov

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