Status:
COMPLETED
Rapid Biochemical Diagnostics of Traumatic Brain Injury
Lead Sponsor:
Medicortex Finland Oy
Conditions:
Traumatic Brain Injury
Concussion, Mild
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients...
Detailed Description
The study will analyze and compare the levels of certain biomolecules and cellular degradation products which are released upon a brain injury and which become detectable in the body fluids. Patients ...
Eligibility Criteria
Inclusion
- Signed written informed consent form (Finnish or Swedish)
- Age 18 - 75 years (Male or Female)
- For patients with a suspected TBI: Presenting to the ED within 4 hours after the injury, and no orthopedic trauma (fractures of long bones) present.
- For patients with a suspected TBI: Deemed to have a computed tomography (CT) scan as a part of their intended medical diagnosis and treatment.
- For patients with orthopedic injuries: Presentation with a bone fracture, but without any suspicion of any TBI.
Exclusion
- Unknown time of trauma (uncertainty more than 1 hour).
- More than 4 hours from the injury.
- Known or suspected pre-existing neurological condition that can cause the observed symptoms
- For women of child-bearing age: known to be or suspected to be pregnant.
- History of seizures within the last three months.
- History of infection with HIV or hepatitis B, or diagnosed to be positive in the concomitant screening.
- Patients where the presence of TBI cannot be assessed reliably because of alcohol or drugs, especially current use of anti-psychotic or anxiolytic medication.
- History of stroke within three months.
- The subject has a chronic neurodegenerative, metabolic (e.g. diabetes), or an autoimmune disease.
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03306563
Start Date
December 28 2017
End Date
June 7 2021
Last Update
June 8 2021
Active Locations (3)
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1
Satakunta Central Hospital
Pori, Finland, 28500
2
Turku University Hospital (Tyks)
Turku, Finland
3
Vaasa Central Hospital
Vaasa, Finland, 65130