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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Anne-Cécile CHIOLLAZ, PharmD; Phone Number: +41223795894; Email: anne-cecile.chiollaz@unige.ch
• Study Contact Backup: Name: Sergio Manzano, MD; Email: sergio.manzano@hcuge.ch

Study Locations

• Switzerland
  • Geneve, Switzerland, 1211
    • Recruiting
    • HUG
    • Contact: Anne-Cécile CHIOLLAZ, PharmD; Phone Number: +41223795894; Email: sergio.manzano@hcuge.ch
    • Principal Investigator: Sergio MANZANO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

paediatric patient suffering from a mild TBI within 24 hours

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intracranial injuries on CT scan	Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus	Admission; within 24 hours
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

Collaborators and Investigators

• Sponsor: Pediatric Clinical Research Platform
• Investigators: Principal Investigator: Sergio Manzano, MD, Hôpitaux universitaires de Genève

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 2020-01533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No