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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

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