NCT06233851

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. 1.How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
  2. 2.How can blood biomarker predict post-concussion symptoms?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

3.7 years

First QC Date

January 16, 2024

Last Update Submit

November 5, 2024

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age0 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

paediatric patient suffering from a mild TBI within 24 hours

You may qualify if:

  • mTBI within 24 hours

You may not qualify if:

  • refusal of child or parents
  • evidence of intoxication with alcohol or other substances
  • history of TBI ( less than one month)
  • epilepsy, encephalitis, meningitis, melanoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUG

Geneva, Canton of Geneva, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Sergio Manzano, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 31, 2024

Study Start

October 6, 2020

Primary Completion

June 10, 2024

Study Completion

July 8, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)