Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents

Medicortex Finland Oy1 site in 1 country58 target enrollmentMay 14, 2020

ConditionsBrain Injuries, Traumatic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Injuries, Traumatic
Sponsor: Medicortex Finland Oy
Enrollment: 58
Locations: 1
Primary Endpoint: Biomarker profiles
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.

Detailed Description

The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.

Registry

clinicaltrials.gov

Start Date

May 14, 2020

End Date

April 14, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medicortex Finland Oy

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)
•No more that 6 hours elapsed from the incident of injury at the first sampling
•The patient is conscious
•Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures