CompletedNot Applicable

BLOOD BIOMARKERS in PAEDIATRIC MTBI

Switzerland600 participantsStarted 2020-10-06

Plain-language 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.

Who can participate

Age range

0 Months – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial specifically studied blood biomarkers in children with mild traumatic brain injury — can you explain what blood biomarkers are and whether testing for them could be useful in my child's care right now?
2Since the trial looked at whether blood biomarkers could predict which children needed a CT scan, does that mean there might be a way to reduce radiation exposure from CT scans for kids with mild TBI, and is that something worth considering in our situation?
3The trial also tracked post-concussion symptoms as a key outcome — what symptoms should we be watching for after a mild TBI, and how long do they typically last in children?
4Now that this trial is completed, has any of its findings about blood biomarkers or post-concussion symptoms changed how doctors like you approach diagnosing or monitoring mild TBI in kids?
5Are there any current standard-of-care approaches or other completed studies you'd recommend we look at alongside this trial's results to help us make the most informed decisions about my child's follow-up care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

intracranial injuries on CT scan

Timeframe: Admission; within 24 hours

Post concussion symptoms

Timeframe: 3 months

Trial details

NCT IDNCT06233851

SponsorPediatric Clinical Research Platform

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-10

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials