Clinical Trial Details
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NCT01990768 : Prehospital Tranexamic Acid Use for Traumatic Brain Injury
PhasePhase 2
AgesMin: 15 Years Max: N/A
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
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