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:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT01990768
Eligibility Criteria:
Inclusion Criteria:
1. Blunt or penetrating traumatic mechanism consistent with traumatic brain injury
2. Prehospital Glasgow Coma Score (GCS) score ≤ 12 at any time prior to randomization and administration of sedative and/or paralytic agents
3. Prehospital systolic blood pressure (SBP) ≥ 90 mmHg prior to randomization
4. Prehospital intravenous (IV) or intraosseous (IO) access
5. Estimated Age ≥ 15 (or estimated weight \> 50 kg if age is unknown)
6. Emergency Medicine System (EMS) transport to a participating trauma center
Exclusion Criteria:
1. Prehospital GCS=3 with no reactive pupil
2. Estimated time from injury to hospital arrival \> 2 hours
3. Unknown time of injury - no known reference times to support estimation
4. Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke
5. Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization
6. Burns \> 20% total body surface area (TBSA)
7. Suspected or known prisoners
8. Suspected or known pregnancy
9. Prehospital TXA given prior to randomization
10. Subjects who have activated the "opt-out" process when required by the local regulatory board
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT01990768
Study Brief:
Protocol Section:
NCT01990768