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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04288167

Enrollment

Registered

2020-02-28

Start date

2020-05-14

Completion date

2021-04-14

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic

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.

Interventions

DIAGNOSTIC_TESTSample collection

Samples of urine and saliva will be collected from participants using customary sample collection means.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Masking description

The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026