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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04171960
Eligibility Criteria:
Acute Blood Biomarker Branch Subject Inclusion Criteria:
1. 18 years of age or older.
2. Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
3. Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury.
4. Subject has a CT scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head CT scan sent from the originating facility.
5. As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following.
1. Any period of loss of consciousness
2. Any loss of memory for events immediately before or after the injury
3. Any alteration of mental state at the time of the injury
4. Focal neurological deficits that may or may not be transient
Acute Blood Biomarker Branch Subject Exclusion Criteria.
1. Previous enrollment in this study
2. Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
3. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
4. Time of injury is unknown and cannot be estimated
5. Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association \[ASIA\] score of C or worse) at the enrolling facility
6. Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
7. Prisoners or patients in custody
8. Patients on psychiatric hold
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04171960
Study Brief:
Protocol Section:
NCT04171960