Overview
Start/End Dates
Locations
Vancouver General Hospital
Name/Title
Barb Boychuk/Study Manager
Phone
Purpose of Study
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.
Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital IV or intraosseous (IO) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport to a participating trauma center.
Exclusion: GCS=3 with no reactive pupil, estimated time from injury to hospital arrival >2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity or known history of seizures, acute MI or stroke, CPR by EMS prior to randomization, burns > 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA given prior to randomization, subjects who have activated the "opt-out" process when required by the local regulatory board.
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.
Eligibility
For more information please click here.
Disclaimer
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.
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.
Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital IV or intraosseous (IO) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport to a participating trauma center.
Exclusion: GCS=3 with no reactive pupil, estimated time from injury to hospital arrival >2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity or known history of seizures, acute MI or stroke, CPR by EMS prior to randomization, burns > 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA given prior to randomization, subjects who have activated the "opt-out" process when required by the local regulatory board.
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.
For more information please click here.
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.
