Status:
COMPLETED
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Lead Sponsor:
Medicortex Finland Oy
Collaborating Sponsors:
Satasairaala
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
1-17 years
Phase:
NA
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 we...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04288167
Start Date
May 14 2020
End Date
April 14 2021
Last Update
May 3 2021
Active Locations (1)
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1
Satakunta Central Hospital
Pori, Finland, 28500