Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04288167
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
17 Years
Study:
NCT04288167
Study Brief:
Protocol Section:
NCT04288167