Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Not Applicable
Completed
- Conditions
- Brain Injuries, Traumatic
- 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.
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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Satakunta Central Hospital
🇫🇮Pori, Finland
Satakunta Central Hospital🇫🇮Pori, Finland