BLOOD BIOMARKERS in PAEDIATRIC MTBI

NCT ID: NCT06233851

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2024-07-08

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mTBI patient

Children \<16 years-old who suffered a head trauma in the last 24 hours with signs of mild traumatic brain injury

No interventions assigned to this group

control

Children \<16 years-old who have a scheduled blood test for any reason

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Clinical Research Platform

OTHER

Sponsor Role: lead

Responsible Party

Sergio MANZANO

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Manzano, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

HUG

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

2020-01533

Identifier Type: -

Identifier Source: org_study_id