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Prehospital Tranexamic Acid Use for Traumatic Brain Injury

Overview

Información sobre este estudio

Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12).

Primary hypothesis: The null hypothesis is that prehospital administration either of two dosing regimens of TXA in patients with moderate to severe TBI will not increase the proportion of patients with a favorable long-term neurologic outcome compared to placebo, based on the GOS-E at 6 months.

Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA:

  • Clinical outcomes: ICH progression, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days.
  • Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism.
  • Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG.

A multi-center double-blind randomized controlled trial with 3 treatment arms:

  • Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.
  • Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
  • Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20192462

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