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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT04641767
Eligibility Criteria:
BIOTRABIS\>18 (adult patients)
Inclusion Criteria:
* Patients over 18 years old
* Mild TBI patients the first 24 hours after trauma with GCS of 14-15 points.
* Presence of any of the following symptoms:
* Loss of consciousness less than 30 minutes, the first 20 minutes after trauma
* Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:
* Persistent headache
* Nausea / vomiting
* Vertigo / dizziness
* Confusion / disorientation
Exclusion Criteria:
* Recent history (\<1 month) of TBI
* Refusal to participate in the study
* Evidence of alcohol or other substance intoxication
* Epilepsy
* Schizophrenia
BIOTRABIS\<18 (paediatric patients)
Inclusion Criteria:
* Patients between 0 and 17 years old.
* Mild TBI (GCS 14-15) and moderate TBI (GCS 9-13) patients the first 24 hours after trauma.
* Presence of any of the following symptoms:
* Loss of consciousness less than 30 minutes, the first 20 minutes after trauma
* Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:
* Persistent headache
* Nausea / vomiting
* Vertigo / dizziness
* Confusion / disorientation
Exclusion Criteria:
* Recent history (\<1 month) of TBI
* Refusal to participate in the study
* Evidence of alcohol or other substance intoxication
* Epilepsy
* Schizophrenia
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04641767
Study Brief:
Protocol Section:
NCT04641767