BLOOD BIOMARKERS in PAEDIATRIC MTBI | NCT06233851

Studies
BLOOD BIOMARKERS in PAEDIATRIC MTBI

NCT06233851

Sponsor

Pediatric Clinical Research Platform

Status

Completed

Last Update Posted

Nov 7, 2024Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Mild Traumatic Brain Injury

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2020Actual

Primary Completion Date

Jun 10, 2024Actual

Completion Date

Jul 8, 2024Actual

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Jan 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2024

Last Update Posted Date

Nov 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sergio MANZANO, professor, Pediatric Clinical Research PlatformPrincipal Investigator

Lead Sponsor

Pediatric Clinical Research PlatformOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

paediatric patient suffering from a mild TBI within 24 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergio Manzano, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HUG		Geneva	Canton of Geneva	1211	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001924	Brain Concussion

Ancestor Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases

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Browse Branches

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