Safety and Efficacy of Hospital Utilization of Tranexamic Acid in Civilian Adult Trauma Resuscitation.

INTRODUCTION: Patients with trauma-induced coagulopathies may benefit from the use of antifibrinolytic agents, such as tranexamic acid (TXA). This study evaluated the safety and efficacy of TXA in civilian adults hospitalized with traumatic hemorrhagic shock. METHODS: Patients who sustained blunt or penetrating trauma with signs of hemorrhagic shock from June 2014 through July 2018 were considered for TXA treatment. A retrospective control group was formed from patients seen in the same past five years who were not administered TXA and matched based on age, gender, Injury Severity Score (ISS), and mechanism of injury (blunt vs penetrating trauma). The primary outcome of this study was mortality measured at 24 hours, 48 hours, and 28 days. Secondary outcomes included total blood products transfused, hospital length of stay (LOS), intensive care unit LOS, and adverse events. We conducted three pre-specified subgroup analyses to assess outcomes of patients, including (1) those who were severely injured (ISS >15), (2) those who sustained significant blood loss (≥10 units of total blood products transfused), and (3) those who sustained blunt vs penetrating trauma. RESULTS: Propensity matching yielded two cohorts: the hospital TXA group (n = 280) and a control group (n = 280). The hospital TXA group had statistically lower mortality at 28 days (1.1% vs 5%, odds ratio [OR] [0.21], (95% confidence interval [CI], 0.06, 0.72)) and used fewer units of blood products (median = 4 units, interquartile range (IQR) = [1, 10] vs median=7 units, IQR = [2, 12.5] for the hospital TXA and control groups, respectively, (95% CI for the difference in median, -3 to -1). There were no statistically significant differences between groups with regard to 24-hour mortality (1.1% vs 1.1%, OR = 1, 95% CI, 0.20, 5.00), 48-hour mortality (1.1% vs 1.4%, OR [0.74], 95% CI, 0.17, 3.37), hospital LOS (median= 9 days, IQR = (5, 16) vs median =12 days IQR = (6, 22.5) for the hospital TXA and control groups, respectively, 95% CI for the difference in median = (-5 to 0)), and incidence of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism) during hospital stay (0.7% vs 0.7% for the hospital TXA and control group, respectively, OR [1], 95% CI, 0.14 to 7.15). We conducted subgroup analyses on patients with ISS>15, patients transfused with ≥10 units of blood products, and blunt vs penetrating trauma. The results indicated lower 28-day mortality for ISS>15 (1.8% vs 7.1%, OR [0.23], 95% CI, 0.06 to 0.81) and blunt trauma (0.6% vs 6.3%, OR [0.09], 95% CI, 0.01 to 0.75); fewer units of blood products for penetrating trauma (median = 2 units, IQR = (1, 8) vs median = 8 units, IQR = (5, 15) for the hospital TXA and control groups, respectively, 95% CI for the difference in median = (-6 to -3)), and ISS>15 (median = 7 units, IQR = (2, 14) vs median = 8.5 units, IQR = (4, 16) for the hospital TXA and control groups, respectively, 95% CI for the difference in median, -3 to 0). CONCLUSION: The current study demonstrates a statistically significant reduction in mortality after TXA administration at 28 days, but not at 24 and 48 hours, in patients with traumatic hemorrhagic shock.

Tranexamic Acid in Civilian Trauma Care in the California Prehospital Antifibrinolytic Therapy Study.

INTRODUCTION: Hemorrhage 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. METHODS: The 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. RESULTS: We 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. CONCLUSION: Findings 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.

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

INTRODUCTION: The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to assess the safety and impact on patient mortality of tranexamic acid (TXA) administration in cases of trauma-induced hemorrhagic shock. The current study further aimed to assess the feasibility of prehospital TXA administration by 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 retrospective chart-review comparison. Trauma patients identified in the prehospital setting with signs of hemorrhagic shock by first responders were administered one gram of TXA followed by an optional second one-gram dose upon arrival to the hospital, if the patient still met inclusion criteria. Patients administered TXA make up the prehospital intervention group. Control group patients met the same inclusion criteria as TXA candidates and were 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. Secondary outcomes measured included the total blood products transfused and any known adverse events associated with 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-hour mortality 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% for intervention and control, respectively, p=0.23). There was no significant difference observed in known adverse events associated with TXA administration in the prehospital intervention group and control group. A reduction 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 in the prehospital setting with no significant change in adverse events observed and an associated decreased use of blood products in cases of trauma-induced hemorrhagic shock. Given the current sample size, a statistically significant decrease in mortality was not observed. Additionally, this study demonstrates that it may be feasible for paramedics to identify and safely administer TXA in the prehospital setting.

Alternative Destination Transport? The Role of Paramedics in Optimal Use of the Emergency Department.

INTRODUCTION: Alternative destination transportation by emergency medical services (EMS) is a subject of hot debate between those favoring all patients being evaluated by an emergency physician (EP) and those recognizing the need to reduce emergency department (ED) crowding. This study aimed to determine whether paramedics could accurately assess a patient's acuity level to determine the need to transport to an ED. METHODS: We performed a prospective double-blinded analysis of responses recorded by paramedics and EPs of arriving patients' acuity level in a large Level II trauma center between April 2015 and November 2015. Under-triage was defined as lower acuity assessed by paramedics but higher acuity by EPs. Over-triage was defined as higher acuity assessed by paramedics but lower acuity by EPs. The degree of agreement between the paramedics and EPs' evaluations of patient's acuity level was compared using Chi-square test. RESULTS: We included a total of 503 patients in the final analysis. For paramedics, 2 51 (49.9%) patients were assessed to be emergent, 178 (35.4%) assessed as urgent, and 74 (14.7%) assessed as non-emergent/non-urgent. In comparison, the EPs assessed 296 (58.9%) patients as emergent, 148 (29.4%) assessed as urgent, and 59 (11.7%) assessed as non-emergent/non-urgent. Paramedics agreed with EPs regarding the acuity level assessment on 71.8% of the cases. The overall under- and over-triage were 19.3% and 8.9%, respectively. A moderate Kappa=0.5174 indicated moderate inter-rater agreement between paramedics' and EPs' assessment on the same cohort of patients. CONCLUSION: There is a significant difference in paramedic and physician assessment of patients into emergent, urgent, or non-emergent/non-urgent categories. The field triage of a patient to an alternative destination by paramedics under their current scope of practice and training cannot be supported.

Accuracy of Perceived Estimated Travel Time by EMS to a Trauma Center in San Bernardino County, California.

INTRODUCTION: Mobilization of trauma resources has the potential to cause ripple effects throughout hospital operations. One major factor affecting efficient utilization of trauma resources is a discrepancy between the prehospital estimated time of arrival (ETA) as communicated by emergency medical services (EMS) personnel and their actual time of arrival (TOA). The current study aimed to assess the accuracy of the perceived prehospital estimated arrival time by EMS personnel in comparison to their actual arrival time at a Level II trauma center in San Bernardino County, California. METHODS: This retrospective study included traumas classified as alerts or activations that were transported to Arrowhead Regional Medical Center in 2013. We obtained estimated arrival time and actual arrival time for each transport from the Surgery Department Trauma Registry. The difference between the median of ETA and actual TOA by EMS crews to the trauma center was calculated for these transports. Additional variables assessed included time of day and month during which the transport took place. RESULTS: A total of 2,454 patients classified as traumas were identified in the Surgery Department Trauma Registry. After exclusion of trauma consults, walk-ins, handoffs between agencies, downgraded traumas, traumas missing information, and traumas transported by agencies other than American Medical Response, Ontario Fire, Rialto Fire or San Bernardino County Fire, we included a final sample size of 555 alert and activation classified traumas in the final analysis. When combining all transports by the included EMS agencies, the median of the ETA was 10 minutes and the median of the actual TOA was 22 minutes (median of difference=9 minutes, p<0.0001). Furthermore, when comparing the difference between trauma alerts and activations, trauma activations demonstrated an equal or larger difference in the median of the estimated and actual time of arrival (p<0.0001). We also found month and time of day to be associated with variability in the difference between the median of the estimated and actual arrival time (p=0.0082 and p=0.0005 for month and time of the day, respectively). CONCLUSION: EMS personnel underestimate their travel time by a median of nine minutes, which may cause the trauma team to abandon other important activities in order to respond to the emergency department prematurely. The discrepancy between ETA and TOA is unpredictable, varying by month and time of day. As such, a better method of estimating patient arrival time is needed.