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Efficacy and Safety of Tranexamic Acid in Prehospital Traumatic Hemorrhagic Shock: Outcomes of the Cal-PAT Study

Abstract

Introduction: The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to assess thesafety and impact on patient mortality of tranexamic acid (TXA) administration in cases of trauma-inducedhemorrhagic shock. The current study further aimed to assess the feasibility of prehospital TXA administrationby paramedics within the framework of North American emergency medicine standards and protocols.

Methods: This is an ongoing multi-centered, prospective, observational cohort study with a retrospectivechart-review comparison. Trauma patients identified in the prehospital setting with signs of hemorrhagicshock by first responders were administered one gram of TXA followed by an optional second one-gram doseupon arrival to the hospital, if the patient still met inclusion criteria. Patients administered TXA make up theprehospital intervention group. Control group patients met the same inclusion criteria as TXA candidates andwere matched with the prehospital intervention patients based on mechanism of injury, injury severity score,and age. The primary outcomes were mortality, measured at 24 hours, 48 hours, and 28 days. Secondaryoutcomes measured included the total blood products transfused and any known adverse events associatedwith TXA administration.

Results: We included 128 patients in the prehospital intervention group and 125 in the control group.Although not statistically significant, the prehospital intervention group trended toward a lower 24-hourmortality rate (3.9% vs 7.2% for intervention and control, respectively, p=0.25), 48-hour mortality rate (6.3%vs 7.2% for intervention and control, respectively, p=0.76), and 28-day mortality rate (6.3% vs 10.4% forintervention and control, respectively, p=0.23). There was no significant difference observed in knownadverse events associated with TXA administration in the prehospital intervention group and control group. Areduction in total blood product usage was observed following the administration of TXA (control: 6.95 units;intervention: 4.09 units; p=0.01).

Conclusion: Preliminary evidence from the Cal-PAT study suggests that TXA administration may be safe inthe prehospital setting with no significant change in adverse events observed and an associated decreaseduse of blood products in cases of trauma-induced hemorrhagic shock. Given the current sample size, astatistically significant decrease in mortality was not observed. Additionally, this study demonstrates thatit may be feasible for paramedics to identify and safely administer TXA in the prehospital setting.

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