Abstract

IntroductionHemorrhage is one of the leading causes of death in trauma victims. Historically, paramedics have not had access to medications that specifically target the reversal of trauma-induced coagulopathies. The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the safety and efficacy of tranexamic acid (TXA) use in the civilian prehospital setting in cases of traumatic hemorrhagic shock.MethodsThe Cal-PAT study is a multi-centered, prospective, observational cohort study with a retrospective comparison. From March 2015 to July 2017, patients ≥ 18 years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified by first responders in the prehospital setting were considered for TXA treatment. A control group was formed of patients seen in the five years prior to data collection cessation (June 2012 to July 2017) at each receiving center who were not administered TXA. Control group patients were selected through propensity score matching based on gender, age, Injury Severity Scores, and mechanism of injury. The primary outcome assessed was mortality recorded at 24 hours, 48 hours, and 28 days. Additional variables assessed included total blood products transfused, the hospital and intensive care unit length of stay, systolic blood pressure taken prior to TXA administration, Glasgow Coma Score observed prior to TXA administration, and the incidence of known adverse events associated with TXA administration.ResultsWe included 724 patients in the final analysis, with 362 patients in the TXA group and 362 in the control group. Reduced mortality was noted at 28 days in the TXA group in comparison to the control group (3.6% vs. 8.3% for TXA and control, respectively, odds ratio [OR]=0.41 with 95% confidence interval [CI] [0.21 to 0.8]). This mortality difference was greatest in severely injured patients with ISS >15 (6% vs 14.5% for TXA and control, respectively, OR=0.37 with 95% CI [0.17 to 0.8]). Furthermore, a significant reduction in total blood product transfused was observed after TXA administration in the total cohort as well as in severely injured patients. No significant increase in known adverse events following TXA administration were observed.ConclusionFindings from the Cal-PAT study suggest that TXA use in the civilian prehospital setting may safely improve survival outcomes in patients who have sustained traumatic injury with signs of hemorrhagic shock.

Highlights

  • Hemorrhage is one of the leading causes of death in trauma victims

  • Reduced mortality was noted at 28 days in the tranexamic acid (TXA) group in comparison to the control group (3.6% vs. 8.3% for TXA and control, respectively, odds ratio [OR]=0.41 with 95% confidence interval [CI] [0.21 to 0.8])

  • This mortality difference was greatest in severely injured patients with Injury Severity Score (ISS) >15 (6% vs 14.5% for TXA and control, respectively, OR=0.37 with 95% CI [0.17 to 0.8])

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Summary

Introduction

Hemorrhage is one of the leading causes of death in trauma victims. Historically, paramedics have not had access to medications that target the reversal of trauma-induced coagulopathies. In the United States (U.S.), traumatic injury is the leading cause of death and disability among those aged 1 to 44 years old.[1] Among trauma victims, hemorrhage accounts for 30% to 40% of the mortality.[2,3,4] Within the prehospital setting, hemorrhage is one of the top causes of death and comprises the largest portion of preventable deaths.[2,3] Significant blood volume loss leads to the depletion of coagulation factors and dysregulation of the coagulation system. The burden of trauma-induced coagulopathies (TIC) has been demonstrated in more than half of trauma patients following arrival to trauma centers and has been associated with a significant increase in the risk of trauma-induced mortality.[5,6,7,8,9] Historically, paramedics have not had access to medications that target the reversal of TIC.[3,4] As biotechnological advances enable better detection and understanding of TIC, a group of patients has been identified that may benefit from early reversal of traumatic coagulopathies, leading to a possible reduction in associated mortality.[8,10,11,12]

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