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

Not Applicable

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Diagnostic Test: Sample collection

• Registration Number: NCT04288167
• Lead Sponsor: Medicortex Finland Oy

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.

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-28
• Study Start: 2020-05-14
• Status Verified: 2021-04
• Primary Completion: 2021-04-14
• Study Completion: 2021-04-14
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with suspected brain injury	Sample collection	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.
Healthy controls	Sample collection	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Satakunta Central Hospital; 🇫🇮 Pori, Finland