Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock.

BACKGROUND: After a person has been injured, prehospital administration of plasma in addition to the initiation of standard resuscitation procedures in the prehospital environment may reduce the risk of downstream complications from hemorrhage and shock. Data from large clinical trials are lacking to show either the efficacy or the risks associated with plasma transfusion in the prehospital setting. METHODS: To determine the efficacy and safety of prehospital administration of thawed plasma in injured patients who are at risk for hemorrhagic shock, we conducted a pragmatic, multicenter, cluster-randomized, phase 3 superiority trial that compared the administration of thawed plasma with standard-care resuscitation during air medical transport. The primary outcome was mortality at 30 days. RESULTS: A total of 501 patients were evaluated: 230 patients received plasma (plasma group) and 271 received standard-care resuscitation (standard-care group). Mortality at 30 days was significantly lower in the plasma group than in the standard-care group (23.2% vs. 33.0%; difference, -9.8 percentage points; 95% confidence interval, -18.6 to -1.0%; P=0.03). A similar treatment effect was observed across nine prespecified subgroups (heterogeneity chi-square test, 12.21; P=0.79). Kaplan-Meier curves showed an early separation of the two treatment groups that began 3 hours after randomization and persisted until 30 days after randomization (log-rank chi-square test, 5.70; P=0.02). The median prothrombin-time ratio was lower in the plasma group than in the standard-care group (1.2 [interquartile range, 1.1 to 1.4] vs. 1.3 [interquartile range, 1.1 to 1.6], P<0.001) after the patients' arrival at the trauma center. No significant differences between the two groups were noted with respect to multiorgan failure, acute lung injury-acute respiratory distress syndrome, nosocomial infections, or allergic or transfusion-related reactions. CONCLUSIONS: In injured patients at risk for hemorrhagic shock, the prehospital administration of thawed plasma was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation. (Funded by the U.S. Army Medical Research and Materiel Command; PAMPer ClinicalTrials.gov number, NCT01818427 .).

Perceived performance and impact of a non-physician-led interprofessional team in a trauma clinic setting.

Faced with the challenge of meeting the wide degree of post-discharge needs in their trauma population, the University of Pittsburgh Medical Center (UPMC) developed a non-physician-led interprofessional team to provide follow-up care at its UPMC Falk Trauma Clinic. We assessed this model of care using a survey to gauge team member perceptions of this model, and used clinic visit documentation to apply a novel approach to assessing how this model improves the care received by clinic patients. The high level of perceived team performance and cohesion suggests that this model has been successful thus far from a provider perspective. Patients are seen most frequently by audiologists, while approximately half of physical therapy and speech language therapy consults generate a new therapy referral, which is interpreted as a potential change in the patient's care trajectory. The broader message of this analysis is that a collaborative, non-hierarchical team model incorporating rehabilitative specialists, who often operate independently of one another, can be successful in this setting, where patients appear to have a strong and previously under-attended need for rehabilitative intervention.

Development and Validation of the Air Medical Prehospital Triage Score for Helicopter Transport of Trauma Patients.

OBJECTIVE: The aim of this study was to develop and internally validate a triage score that can identify trauma patients at the scene who would potentially benefit from helicopter emergency medical services (HEMS). SUMMARY BACKGROUND DATA: Although survival benefits have been shown at the population level, identification of patients most likely to benefit from HEMS transport is imperative to justify the risks and cost of this intervention. METHODS: Retrospective cohort study of subjects undergoing scene HEMS or ground emergency medical services (GEMS) in the National Trauma Databank (2007-2012). Data were split into training and validation sets. Subjects were grouped by triage criteria in the training set and regression used to determine which criteria had a survival benefit associated with HEMS. Points were assigned to these criteria to develop the Air Medical Prehospital Triage (AMPT) score. The score was applied in the validation set to determine whether subjects triaged to HEMS had a survival benefit when actually transported by helicopter. RESULTS: There were 2,086,137 subjects included. Criteria identified for inclusion in the AMPT score included GCS <14, respiratory rate <10 or >29, flail chest, hemo/pneumothorax, paralysis, and multisystem trauma. The optimal cutoff for triage to HEMS was ≥2 points. In subjects triaged to HEMS, actual transport by HEMS was associated with an increased odds of survival (AOR 1.28; 95% confidence interval [CI] 1.21-1.36, P < 0.01). In subjects triaged to GEMS, actual transport mode was not associated with survival (AOR 1.04; 95% CI 0.97-1.11, P = 0.20). CONCLUSIONS: The AMPT score identifies patients with improved survival following HEMS transport and should be considered in air medical triage protocols.

Geographic Variation in Outcome Benefits of Helicopter Transport for Trauma in the United States: A Retrospective Cohort Study.

OBJECTIVE: Evaluate the effect of US geographic region on outcomes of helicopter transport (HT) for trauma. BACKGROUND: HT is an integral component of trauma systems. Evidence suggests that HT is associated with improved outcomes; however, no studies examine the impact of geographic variation on outcomes for HT. METHODS: Retrospective cohort study of patients undergoing scene HT or ground transport in the National Trauma Databank (2009-2012). Subjects were divided by US census region. HT and ground transport subjects were propensity-score matched based on prehospital physiology and injury severity. Conditional logistic regression was used to evaluate the effect of HT on survival and discharge to home in each region. Region-level characteristics were assessed as potential explanatory factors. RESULTS: A total of 193,629 pairs were matched. HT was associated with increased odds of survival and discharge to home; however, the magnitude of these effects varied significantly across regions (P < 0.01). The South had the greatest survival benefit (odds ratio: 1.44; 95% confidence interval: 1.39-1.49, P < 0.01) and the Northeast had the greatest discharge to home benefit (odds ratio: 1.29; 95% confidence interval: 1.18-1.41, P < 0.01). A subset of region-level characteristics influenced the effect of HT on each outcome, including helicopter utilization, injury severity, trauma center and helicopter distribution, trauma center access, traffic congestion, and urbanicity (P < 0.05). CONCLUSIONS: Geographic region impacts the benefits of HT in trauma. Variations in resource allocation partially account for outcome differences. Policy makers should consider regional factors to better assess and allocate resources within trauma systems to optimize the role of HT.

Surgical Site Infection 18 Months Following Intrathecal Pump Placement Secondary to an Asymptomatic Bowel Injury.

Surgical site infections following the implantation of intrathecal drug delivery systems typically present during the first 1 to 2 months following surgery. Surgical site infections occurring outside of this window are rare entities and require special attention to identify the source or underlying cause. In this report, we present a case of pump pocket infection 18 months following implantation due to an asymptomatic and unrecognized bowel injury associated with the catheter. This case highlights the need for a thorough evaluation in a patient with suspected infections more than 2 months after surgery to ensure adequate treatment.

Preinjury Frailty Predicts 1-Year Mortality in Older Adults With Traumatic Spine Fractures.

BACKGROUND AND OBJECTIVES: Nearly 30% of older adults presenting with isolated spine fractures will die within 1 year. Attempts to ameliorate this alarming statistic are hindered by our inability to identify relevant risk factors. The primary objective of this study was to develop a prediction model that identifies feasible targets to limit 1-year mortality. METHODS: This retrospective cohort study included 703 older adults (65 years or older) admitted to a level I trauma center with isolated spine fractures, without neural deficit, from January 2013 to January 2018. Multivariable analysis was used to select for independently significant patient demographics, frailty variables, injury metrics, and management decisions to incorporate into distinct logistic regression models predicting 1-year mortality. Variables were considered significant, if P < .05. RESULTS: Of the 703 older adults, 199 (28.3%) died after hospital discharge, but within 1 year of index trauma. Risk Analysis Index (RAI; odds ratio [OR]: 1.116; 95% CI: 1.087-1.149; P < .001) and ambulation requiring a cane (OR: 2.601; 95% CI: 1.151-5.799; P = .02) or walker (OR: 4.942; 95% CI: 2.698-9.196; P < .001), ie, frailty variables, were associated with increased odds of 1-year mortality. Spine trauma scales were not associated with 1-year mortality. Longer hospital stays (OR: 1.112; 95% CI: 1.034-1.196; P = .004) and nursing home discharge (OR: 3.881; 95% CI: 2.070-7.378; P < .001) were associated with increased odds, while discharge to rehab (OR: 0.361; 95% CI: 0.155-0.799; P = .014) decreased 1-year mortality odds. A "preinjury" regression model incorporating Risk Analysis Index and ambulation status resulted in an area under receiver operating characteristic curve (AUROCC) of 0.914 (95% CI: 0.863-0.965). A "postinjury" model incorporating Glasgow Coma Scale, hospital stay duration, and discharge disposition resulted in AUROCC of 0.746 (95% CI: 0.642-0.849). Combining elements of the preinjury and postinjury models into an "integrated model" produced an AUROCC of 0.908 (95% CI: 0.852-0.965). CONCLUSION: Preinjury frailty measures are most strongly associated with 1-year mortality outcomes in older adults with isolated spine fractures. Incorporating injury metrics or management decisions did not enhance predictive accuracy. Further work is needed to understand how targeting frailty may reduce mortality.

The association between air ambulance distribution and trauma mortality.

OBJECTIVE: To determine whether increasing distance between helicopter ambulance airbase and either home residence or referring facility is associated with an increased risk of injury-related mortality. BACKGROUND: A dramatic increase in the absolute number and utilization of Helicopter Emergency Medical Services transports has occurred in the management of the critically injured patients. HEMS are resource intensive, and the most efficient geographic distribution of airbases necessary to improve patient outcomes is unknown. METHODS: We performed a retrospective analysis of 244,293 adult trauma patients who were treated at a designated trauma center (TC) in Pennsylvania during the period 1997 to 2007, using the Pennsylvania Trauma Outcomes Study data set. We performed a multivariate analysis, adjusting for differences in case mix, to determine whether airbase proximity to either residence or referring facility is associated with injury-related mortality. RESULTS: For patients residing distant (>20 miles) from a TC, increasing distance from an airbase is associated with an increased risk of death; for each mile, the risk of mortality increases by approximately 1% (adjusted odds ratio, 1.011; 95% confidence interval, 1.002-1.018; P = 0.02). There is no additional benefit to living close (<25 miles) to more than 1 airbase. However, most airbases are positioned near TC and other airbases. Despite the proliferation of helicopter ambulances, 18.1% of patients who did not live near a TC also did not live near airbase. CONCLUSIONS: For individuals residing distant from a TC, proximity to 1 airbase is associated with reduced risk of death. No additional benefit is observed when airbases are positioned close to a TC or other airbases.

Testing a Novel Deliberate Practice Intervention to Improve Diagnostic Reasoning in Trauma Triage: A Pilot Randomized Clinical Trial.

Importance: Diagnostic errors made during triage at nontrauma centers contribute to preventable morbidity and mortality after injury. Objective: To test the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to improve diagnostic reasoning in trauma triage. Design, Setting, and Participants: This pilot randomized clinical trial was conducted online in a national convenience sample of 72 emergency physicians between January 1 and March 31, 2022, without follow-up. Interventions: Participants were randomly assigned to receive either usual care (ie, passive control) or a deliberate practice intervention, consisting of 3 weekly, 30-minute, video-conferenced sessions during which physicians played a customized, theory-based video game while being observed by content experts (coaches) who provided immediate, personalized feedback on diagnostic reasoning. Main Outcomes and Measures: Using the Proctor framework of outcomes for implementation research, the feasibility, fidelity, acceptability, adoption, and appropriateness of the intervention was assessed by reviewing videos of the coaching sessions and conducting debriefing interviews with participants. A validated online simulation was used to assess the intervention's effect on behavior, and triage among control and intervention physicians was compared using mixed-effects logistic regression. Implementation outcomes were analyzed using an intention-to-treat approach, but participants who did not use the simulation were excluded from the efficacy analysis. Results: The study enrolled 72 physicians (mean [SD] age, 43.3 [9.4] years; 44 men [61%]) but limited registration of physicians in the intervention group to 30 because of the availability of the coaches. Physicians worked in 20 states; 62 (86%) were board certified in emergency medicine. The intervention was delivered with high fidelity, with 28 of 30 physicians (93%) completing 3 coaching sessions and with coaches delivering 95% of session components (642 of 674). A total of 21 of 36 physicians (58%) in the control group participated in outcome assessment; 28 of 30 physicians (93%) in the intervention group participated in semistructured interviews, and 26 of 30 physicians (87%) in the intervention group participated in outcome assessment. Most physicians in the intervention group (93% [26 of 28]) described the sessions as entertaining and valuable; most (88% [22 of 25]) affirmed the intention to adopt the principles discussed. Suggestions for refinement included providing more time with the coach and addressing contextual barriers to triage. During the simulation, the triage decisions of physicians in the intervention group were more likely to adhere to clinical practice guidelines than those in the control group (odds ratio; 13.8, 95% CI, 2.8-69.6; P = .001). Conclusions and Relevance: In this pilot randomized clinical trial, coaching was feasible and acceptable and had a large effect on simulated trauma triage decisions, setting the stage for a phase 3 trial. Trial Registration: ClinicalTrials.gov Identifier: NCT05168579.

Testing the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to reduce diagnostic error in trauma triage: a study protocol for a randomized pilot trial.

BACKGROUND: Non-compliance with clinical practice guidelines in trauma remains common, in part because physicians make diagnostic errors when triaging injured patients. Deliberate practice, purposeful participation in a training task under the oversight of a coach, effectively changes behavior in procedural domains of medicine but has rarely been used to improve diagnostic skill. We plan a pilot parallel randomized trial to test the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to reduce physician diagnostic errors in trauma triage. METHODS: We will randomize a national convenience sample of physicians who work at non-trauma centers (n = 60) in a 1:1 ratio to a deliberate practice intervention or to a passive control. We will use a customized, theory-based serious video game as the basis of our training task, selected based on its behavior change techniques and game mechanics, along with a coaching manual to standardize the fidelity of the intervention delivery. The intervention consists of three 30-min sessions with content experts (coaches), conducted remotely, during which physicians (trainees) play the game and receive feedback on their diagnostic processes. We will assess (a) the fidelity with which the intervention is delivered by reviewing video recordings of the coaching sessions; (b) the acceptability of the intervention through surveys and semi-structured interviews, and (c) the effect of the intervention by comparing the performance of trainees and a control group of physicians on a validated virtual simulation. We hypothesize that trainees will make ≥ 25% fewer diagnostic errors on the simulation than control physicians, a large effect size. We additionally hypothesize that ≥ 90% of trainees will receive their intervention as planned. CONCLUSIONS: The results of the trial will inform the decision to proceed with a future hybrid effectiveness-implementation trial of the intervention. It will also provide a deeper understanding of the challenges of using deliberate practice to modify the diagnostic skill of physicians. TRIAL REGISTRATION: Clinical trials.gov ( NCT05168579 ); 23 December 2021.

Prehospital low titer group O whole blood is feasible and safe: Results of a prospective randomized pilot trial.

INTRODUCTION: Low titer group O whole blood (LTOWB) resuscitation is increasingly common in both military and civilian settings. Data regarding the safety and efficacy of prehospital LTOWB remain limited. METHODS: We performed a single-center, prospective, cluster randomized, prehospital through in-hospital whole blood pilot trial for injured air medical patients. We compared standard prehospital air medical care including red cell transfusion and crystalloids followed by in-hospital component transfusion to prehospital and in-hospital LTOWB resuscitation. Prehospital vital signs were used as inclusion criteria (systolic blood pressure ≤90 mm Hg and heart rate ≥108 beats per minute or systolic blood pressure ≤70 mm Hg for patients at risk of hemorrhage). Primary outcome was feasibility. Secondary outcomes included 28-day and 24-hour mortality, multiple organ failure, nosocomial infection, 24-hour transfusion requirements, and arrival coagulation parameters. RESULTS: Between November 2018 and October 2020, 86 injured patients were cluster randomized by helicopter base. The trial has halted early at 77% enrollment. Overall, 28-day mortality for the cohort was 26%. Injured patients randomized to prehospital LTOWB (n = 40) relative to standard care (n = 46) were similar in demographics and injury characteristics. Intent-to-treat Kaplan-Meier survival analysis demonstrated no statistical mortality benefit at 28 days (25.0% vs. 26.1%, p = 0.85). Patients randomized to prehospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours (p < 0.01) and a lower incidence of abnormal thromboelastographic measurements. No transfusion reactions during the prehospital or in-hospital phase of care were documented. CONCLUSION: Prehospital through in-hospital LTOWB resuscitation is safe and may be associated with hemostatic benefits. A large-scale clinical trial is feasible with protocol adjustment and would allow the effects of prehospital LTOWB on survival and other pertinent clinical outcomes to be appropriately characterized. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level II.

Over reliance on computed tomography imaging in patients with severe abdominal injury: is the delay worth the risk?

BACKGROUND: Computed tomography (CT) has a high sensitivity and specificity for detecting abdominal injuries. Expeditious abdominal imaging in "quasi-stable" patients may prevent negative laparotomy. However, the significance of potential delay to laparotomy secondary to abdominal imaging remains unknown. We sought to analyze whether the use of abdominal CT (ABD CT) in patients with abdominal injury requiring laparotomy results in a significant delay and a higher risk of poor outcome. METHODS: A retrospective analysis of data from the National Trauma Data Bank (version 7.1) was performed. Inclusion criteria were adult patients (age>14 years), a scene admission (nontransfer), hypotension on arrival (emergency department systolic blood pressure<90 mm Hg), an abdominal Abbreviated Injury Scale (AIS) score>3, and undergoing a laparotomy within 90 minutes of arrival. Patients with severe brain injury (head AIS score>3) were excluded. The independent mortality risk associated with a preoperative ABD CT was determined using logistic regression after controlling important confounders. RESULTS: This cohort of patients (n=3,218) was significantly injured with a median Injury Severity Score of 25 ([interquartile range, 16-34]). Patients who underwent ABD CT had similar Glasgow Coma Scale scores, a lower head AIS, longer time delays to the operating room, and a higher crude mortality (45% vs. 30%; p=0.001). Logistic regression revealed that ABD CT was independently associated with more than a 70% higher risk of mortality (odds ratios, 1.71; 95% CI, 1.2-2.2; p<0.001). When stratified by injury mechanism, intubation status and whether or not a head CT was performed, the mortality risk remained significantly increased for each subgroup. When the laparotomy was able to occur within 30 minutes of arrival, an ABD CT was independently associated with more than a sevenfold higher risk of mortality (odds ratios, 7.6; p=0.038). CONCLUSION: Delay secondary to abdominal imaging in patients who require operative intervention results in an independent higher risk of mortality. ABD CT imaging is an important and useful tool after injury; however, these results suggest that delay caused by overreliance on ABD CT may result in poor outcome in specific patients. Clinicians who take care of critically injured patients should be aware of and understand these potential risks.

Early lower extremity fracture fixation and the risk of early pulmonary embolus: filter before fixation?

BACKGROUND: Venous thromboembolism is a major cause of morbidity and mortality after injury. Prophylactic anticoagulation is often delayed as a result of injuries or required procedures. Those patients at highest risk in this early vulnerable window postinjury are not well characterized. We sought to determine those patients at highest risk for an early pulmonary embolism (PE) after injury. METHODS: A retrospective analysis using data derived from a large state wide trauma registry (1997-2007) was performed. Patients with a documented PE and time of occurrence were selected (n = 712). Patients with fat emboli and lower extremity vascular injuries were excluded. Patients with a PE within the first 72 hours of admission (EARLY, n = 122) were compared with those with DELAYED presentation. Kaplan-Meier survival analysis was used to characterize the timing of death between the two groups. Backward stepwise logistic regression was used to determine independent risk factors for EARLY PE relative to those with DELAYED PE. RESULTS: EARLY and DELAYED groups were similar in age, gender, Glasgow Coma Scale, emergency department systolic blood pressure, and injury mechanism. The EARLY PE group had a lower Injury Severity Score but injuries more commonly included femur fracture. Kaplan-Meier analysis revealed that EARLY PE patients have a significantly higher risk of early mortality relative to DELAYED PE patients (p = 0.012). Regression analysis revealed that the only independent risk factor for EARLY PE was lower extremity/pelvic orthopedic fixation (<48 hours from injury). The risk of EARLY PE was more than threefold higher (odds ratios, 3.85; 95% CI, 1.9-7.6; p < 0.001) for those who underwent early lower extremity orthopedic fixation versus those who did not. CONCLUSION: Early lower extremity/pelvis orthopedic fixation is the single independent predictor of EARLY PE in this patient cohort. Venous thromboembolism/PE prevention strategies should be made a priority in this group of patients, including early preoperative institution of anticoagulation prophylaxis. These results suggest that those with contraindications to early anticoagulation may benefit from insertion of retrievable inferior vena cava filters preoperatively.

Impact of Coronavirus Disease 2019 Shutdown on Neurotrauma Volume in Pennsylvania.

OBJECTIVE: The 2020 coronavirus disease 2019 (COVID-19) pandemic resulted in state-specific quarantine protocols and introduced the concept of social distancing into modern parlance. We assess the impact of the COVID-19 pandemic on neurotrauma presentations in the first 3 months after shutdown throughout Pennsylvania. METHODS: The Pennsylvania Trauma Systems Foundation was queried for registry data from the Pennsylvania Trauma Outcomes Study between March 12 and June 5 in each year from 2017 to 2020. RESULTS: After the COVID-19 shutdown, there was a 27% reduction in neurotrauma volume, from 2680 cases in 2017 to 2018 cases in 2020, and a 28.8% reduction in traumatic brain injury volume. There was no significant difference in neurotrauma phenotype incurred relative to total cases. Injury mechanism was less likely to be motor vehicle collision and more likely caused by falls, gunshot wound, and recreational vehicle accidents (P < 0.05). Location of injury was less likely on roads and public locations and more likely at indoor private locations (P < 0.05). The proportion of patients with neurotrauma with blood alcohol concentration >0.08 g/dL was reduced in 2020 (11.4% vs. 9.0%; P < 0.05). Mortality was higher during 2020 compared with pre-COVID years (7.7% vs. 6.4%; P < 0.05). CONCLUSIONS: During statewide shutdown, neurotrauma volume and alcohol-related trauma decreased and low-impact traumas and gunshot wounds increased, with a shift toward injuries occurring in private, indoor locations. These changes increased mortality. However, there was not a change in the types of injuries sustained.

Development and validation of a five-factor score for prediction of pathologic pneumatosis.

BACKGROUND: The significance of pneumatosis intestinalis (PI) remains challenging. While certain clinical scenarios are predictive of transmural ischemia, risk models to assess the presence of pathologic PI are needed. The aim of this study was to determine what patient factors at the time of radiographic diagnosis of PI predict the risk for pathologic PI. METHODS: We conducted a retrospective cohort study examining patients with PI from 2010 to 2016 at a multicenter hospital network. Multivariate logistic regression was used to develop a predictive model for pathologic PI in a derivation cohort. Using regression-coefficient-based methods, the final multivariate model was converted into a five-factor-based score. Calibration and discrimination of the score were then assessed in a validation cohort. RESULTS: Of 305 patients analyzed, 102 (33.4%) had pathologic PI. We identified five factors associated with pathologic PI at the time of radiographic diagnosis: small bowel PI, age 70 years or older, heart rate 110 bpm or greater, lactate of 2 mmol/L or greater, and neutrophil-lymphocyte ratio 10 or greater. Using this model, patients in the validation cohort were assigned risk scores ranging from 0 to 11. Low-risk patients were categorized when scores are 0 to 4; intermediate, score of 5 to 6; high, score of 7 to 8; and very high risk, 9+. In the validation cohort, very high-risk patients (n = 17; 18.1%) had predicted rates of pathologic pneumatosis of 88.9% and an observed rate of 82.4%. In contrast, patients labeled as low risk (n = 37; 39.4%) had expected rates of pathologic pneumatosis of 1.3% and an observed rate of 0%. The model showed excellent discrimination (area under the curve, 0.90) and good calibration (Hosmer-Lemeshow goodness-of-fit, p = 0.37). CONCLUSION: Our score accurately stratifies patient risk of pathologic pneumatosis. This score has the potential to target high-risk individuals for expedient operation and spare low-risk individuals invasive interventions. LEVEL OF EVIDENCE: Prognostic Study, Level III.

Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial.

IMPORTANCE: In-hospital administration of tranexamic acid after injury improves outcomes in patients at risk for hemorrhage. Data demonstrating the benefit and safety of the pragmatic use of tranexamic acid in the prehospital phase of care are lacking for these patients. OBJECTIVE: To assess the effectiveness and safety of tranexamic acid administered before hospitalization compared with placebo in injured patients at risk for hemorrhage. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, phase 3, multicenter, double-blind, placebo-controlled, superiority randomized clinical trial included injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019. INTERVENTIONS: Patients received 1 g of tranexamic acid before hospitalization (447 patients) or placebo (456 patients) infused for 10 minutes in 100 mL of saline. The randomization scheme used prehospital and in-hospital phase assignments, and patients administered tranexamic acid were allocated to abbreviated, standard, and repeat bolus dosing regimens on trauma center arrival. MAIN OUTCOMES AND MEASURES: The primary outcome was 30-day all-cause mortality. RESULTS: In all, 927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to tranexamic acid intervention; 467 to placebo intervention). After exclusions, the intention-to-treat study cohort comprised 903 patients: 447 in the tranexamic acid arm and 456 in the placebo arm. Mortality at 30 days was 8.1% in patients receiving tranexamic acid compared with 9.9% in patients receiving placebo (difference, -1.8%; 95% CI, -5.6% to 1.9%; P = .17). Results of Cox proportional hazards regression analysis, accounting for site, verified that randomization to tranexamic acid was not associated with a significant reduction in 30-day mortality (hazard ratio, 0.81; 95% CI, 0.59-1.11, P = .18). Prespecified dosing regimens and post-hoc subgroup analyses found that prehospital tranexamic acid were associated with significantly lower 30-day mortality. When comparing tranexamic acid effect stratified by time to treatment and qualifying shock severity in a post hoc comparison, 30-day mortality was lower when tranexamic acid was administered within 1 hour of injury (4.6% vs 7.6%; difference, -3.0%; 95% CI, -5.7% to -0.3%; P < .002). Patients with severe shock (systolic blood pressure ≤70 mm Hg) who received tranexamic acid demonstrated lower 30-day mortality compared with placebo (18.5% vs 35.5%; difference, -17%; 95% CI, -25.8% to -8.1%; P < .003). CONCLUSIONS AND RELEVANCE: In injured patients at risk for hemorrhage, tranexamic acid administered before hospitalization did not result in significantly lower 30-day mortality. The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events. Tranexamic acid given to injured patients at risk for hemorrhage in the prehospital setting is safe and associated with survival benefit in specific subgroups of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02086500.

The morbidity of trauma nephrectomy.

Mortality has been shown to be high in patients after trauma nephrectomy (TN). However, there are little data regarding morbidity in survivors. The objective of this study was to determine the morbidity rates associated with TN with attention directed to renal failure (RF) and formation of intra-abdominal abscess (IAA). Patients who underwent TN over a 9-year period (1996 to 2004) were identified from the trauma registry. Records were reviewed for all complications after TN in patients surviving at least 48 hours. Eighty-nine patients were identified with TN; 61 per cent resulted after penetrating trauma. Overall mortality was 34 per cent. Seventy-one patients survived greater than 48 hours; 51 (72%) experienced at least one morbidity. There was no difference in morbidity rates between patients undergoing blunt trauma and those undergoing penetrating trama. Patients with morbidities were significantly older, more severely injured, and had higher mortality rates and longer hospital courses. Infectious complications were seen in 52 per cent, respiratory in 48 per cent, gastrointestinal in 30 per cent, coagulopathy in 25 per cent, and RF and IAA were each seen in 14 per cent of patients. Patients undergoing TN are severely injured with significant morbidity. The results from this study allow us to establish benchmarks to assess complication rates for patients who undergo TN, which can provide prognostic information and goals to improve patient outcomes.

Predisposed to failure? The challenge of rescue in the medical intensive care unit.

BACKGROUND: Medical intensive care unit (MICU) patients develop acute surgical processes that require operative intervention. There are limited data addressing outcomes of emergency general surgery (EGS) in this population. The aim of our study was to characterize the breadth of surgical consults from the MICU and assess mortality after abdominal EGS cases. METHODS: All MICU patients with an EGS consult in an academic medical center between January 2010 and 2016 were identified from an electronic medical record-based registry. Charts were reviewed to determine reason for consult, procedures performed, and to obtain additional clinical data. A multivariate logistic regression was used to determine patient factors associated with patient mortality. RESULTS: Of 911 MICU patients seen by our service, 411(45%) required operative intervention, with 186 patients undergoing an abdominal operation. The postoperative mortality rate after abdominal operations was 37% (69/186), significantly higher than the mortality of 16% (1833/11192) for all patients admitted to the MICU over the same period (p < 0.05). Damage-control procedures were performed in 64 (34%) patients, with 46% mortality in this group. The most common procedures were bowel resections, with mortality of 42% (28/66) and procedures for severe clostridium difficile, mortality of 38% (9/24). Twenty-seven patients met our definition of surgical rescue, requiring intervention for complications of prior procedures, with mortality of 48%. Need for surgical rescue was associated with increased admission mortality (odds ratio, 13.07; 95% confidence interval, 2.86-59.77). Twenty-six patients had pathology amenable to surgical intervention but did not undergo operation, with 100% mortality. In patients with abdominal pathology at the time of operation, in-hospital delay was associated with increased mortality (odds ratio, 5.13; 95% confidence interval, 1.11-23.77). CONCLUSION: Twenty percent of EGS consults from the MICU had an abdominal process requiring an operative intervention. While the MICU population as a whole has a high baseline mortality, patients requiring abdominal surgical intervention are an even higher risk. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Parenteral calcium for intensive care unit patients.

BACKGROUND: Hypocalcemia is prevalent among critically ill patients requiring intensive care. Several epidemiological studies highlight a direct association between hypocalcemia and mortality. These data provide the impetus for current guidelines recommending parenteral calcium administration to normalize serum calcium. However, in light of the considerable variation in the threshold for calcium replacement, the lack of evidence to support a causal role of hypocalcemia in mortality, and animal studies illustrating that calcium supplementation may worsen outcomes, a systematic review is essential to evaluate whether or not the practice of calcium supplementation for intensive care unit (ICU) patients provides any benefit. OBJECTIVES: To assess the effects of parenteral calcium administration in ICU patients on the following outcomes: mortality, multiple organ dysfunction, ICU and hospital length of stay, costs, serum ionized calcium concentration, and complications of parenteral calcium administration. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, Current Controlled Trials, and the National Research Register. We hand-searched conference abstracts from the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, the American Thoracic Surgery, the American College of Surgeons, the American College of Chest Physicians, the American College of Physicians, and the International Consensus Conference in Intensive Care Medicine. We checked references of publications and attempted to contact authors to identify additional published or unpublished data. SELECTION CRITERIA: Randomised controlled and controlled clinical trials of ICU patients comparing parenteral calcium chloride or calcium gluconate administration with no treatment or placebo. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied eligibility criteria to trial reports for inclusion and extracted data. MAIN RESULTS: There are no identifiable studies that have evaluated the association between parenteral calcium supplementation in critically ill ICU patients and the following outcomes: mortality, multiple organ dysfunction, ICU and hospital length of stay, costs, and complications of calcium administration. Serum ionized calcium concentration was reported in 5 studies (12 trial arms, 159 participants). These trials showed a small but significant increase in serum ionized calcium concentration after calcium administration. These trials showed considerable statistical heterogeneity and differed extensively in the population studied (adult versus neonate), the indication (hypocalcemia versus prophylaxis) and threshold of hypocalcemia for which parenteral calcium was administered, and the timing of subsequent measurement of serum ionized calcium concentration to the extent that we consider a pooled estimate almost inappropriate. AUTHORS' CONCLUSIONS: There is no clear evidence that parenteral calcium supplementation impacts the outcome of critically ill patients.

Design and implementation of the Western Pennsylvania regional Stop the Bleed initiative.

BACKGROUND: Hemorrhage is the leading cause of preventable death in trauma, and nearly 40% of prehospital deaths can be attributed to blood loss. The Stop the Bleed program provides a structured curriculum for teaching hemorrhage control and the use of bleeding control kits. To overcome implementation barriers and to achieve the goal of making education on bleeding control as common as cardiopulmonary resuscitation, widespread implementation with outreach to the public and law enforcement is necessary. METHODS: We provide a description and analysis of the implementation of a regional Stop the Bleed program, which includes a step-by-step guide to the design of this program provided as a template to guide attempts at large-scale Stop the Bleed program development. RESULTS: Combining the efforts of regional trauma and nontrauma centers as a hub-and-spoke design, a region covering four states, 72 counties, and 30,000 square miles was targeted. A total of 27,291 individuals were trained in a 21-month period including 3,172 trainers, 19,310 lay public, and 4,809 law enforcement officers. A total of 436 bleeding control kits were distributed to 102 public schools, and tourniquets were provided to 4,809 law enforcement officers. Program development and community outreach resulted in official recognition of the program by the Pennsylvania State Senate. CONCLUSIONS: With the use of a multicenter outreach program design with emphasis on law enforcement and public education while developing a train-the-trainer program, widespread and rapid dissemination of Stop the Bleed teaching is feasible. The general steps described in this manuscript may serve as a template for new or developing programs in other areas to increase the national exposure to Stop the Bleed. LEVEL OF EVIDENCE: Economic/Decision study, level IV.

Defining the contribution of renal dysfunction to outcome after traumatic injury.

Renal failure is frequently considered an ominous development after injury, but its impact on outcome is poorly understood. Renal dysfunction or failure can be defined in many ways, such as elevated serum creatinine or the need for dialysis. The best method to characterize renal dysfunction however, is not known. To determine which definition of renal dysfunction correlates best with outcome, we retrospectively analyzed all injured patients from 1994 to 2000 who had an Injury Severity Score > or =14 and a hospital length of stay >2 days for the development of renal impairment. One hundred sixty-seven patients (4%) developed a serum creatinine > or =2.0 mg/dL and 49 patients required dialysis. Patients with renal dysfunction were older, suffered from more comorbid medical problems, were more seriously injured, and were more likely to have been in shock. A serum creatinine > or =2.0 mg/dL, the maximum creatinine level, and need for dialysis, were highly correlated with death, and the total number of dialysis treatments was not. All measures of renal dysfunction correlated relatively poorly with length of stay. These data demonstrate that the simple measure of serum creatinine > or =2.0 mg/dL is associated with a significantly increased likelihood of death in injured patients and is a stronger predictor than other common indicators of renal impairment.