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

Study 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.

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

Conditions
-----------------
Brain Injuries, Traumatic

Intervention / Treatment
-----------------
* Diagnostic Test: Sample collection


Participation Criteria
=================
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 Exclusion Criteria: More than 6 hours elapsed from the injury, or unknown time of trauma Multi-trauma patient History of head injury, seizures or stroke within three preceding months Chronic neurodegenerative, metabolic or autoimmune disease Known existing neurological condition

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with suspected brain injury<br>This arm will consist of up to 30 pediatric patients who entered the Emergency Room and who are suspected of having mild traumatic brain injury. Two sample sets will be collected within the first 10 hours from the injury. | Diagnostic Test: Sample collection<br>* Samples of urine and saliva will be collected from participants using customary sample collection means.<br>|
| Active Comparator: Healthy controls<br>This arm will consist of up to 30 healthy control subjects, the samples of whom will be compared to the samples of brain injury patients (Arm 1). One sample set will be collected from healthy children without any known brain injury. | Diagnostic Test: Sample collection<br>* Samples of urine and saliva will be collected from participants using customary sample collection means.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker levels | Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay | 12 months | 
| Biomarker profiles | Characterization of different glycan structures present in the sample by mass spectrometry analysis | 12 months |