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BLOOD BIOMARKERS in PAEDIATRIC MTBI

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06233851
Acronym
t-BIOMAP
Enrollment
600
Registered
2024-01-31
Start date
2020-10-06
Completion date
2024-07-08
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury

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.

Interventions

None listed

Sponsors

Pediatric Clinical Research Platform
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Months to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post concussion symptoms3 monthsSuch as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)
intracranial injuries on CT scanAdmission; within 24 hoursHemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026