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NCT04288167 Clinical Trial

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

Brain Injuries, Traumatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04288167
Other study ID # T257/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2020
Est. completion date April 14, 2021

Study information
Verified date April 2021
Source Medicortex Finland Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date April 14, 2021
Est. primary completion date April 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Sample collection
Samples of urine and saliva will be collected from participants using customary sample collection means.

Locations
Country Name City State
Finland Satakunta Central Hospital Pori

Sponsors (2)
Lead Sponsor Collaborator
Medicortex Finland Oy Satasairaala

Country where clinical trial is conducted

Finland, 

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