PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.

INTRODUCTION: Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients. METHODS AND ANALYSIS: PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections. ETHICS AND DISSEMINATION: The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients. TRIAL REGISTRATION NUMBER: NCT02984384.

Removal of the Prehospital Tourniquet in the Emergency Department.

BACKGROUND: Life-threatening hemorrhage from extremity injuries can be effectively controlled in the prehospital environment through direct pressure, wound packing, and the use of tourniquets. Early tourniquet application has been prioritized for rapid control of severe extremity hemorrhage and is a cornerstone of prehospital trauma resuscitation guidelines. Emergency physicians must be knowledgeable regarding the initial assessment and appropriate management of patients who present with a prehospital tourniquet in place. DISCUSSION: An interdisciplinary group of experts including emergency physicians, trauma surgeons, and tactical and Emergency Medical Services physicians collaborated to develop a stepwise approach to the assessment and removal (discontinuation) of an extremity tourniquet in the emergency department after being placed in the prehospital setting. We have developed a best-practices guideline to serve as a resource to aid the emergency physician in how to safely remove a tourniquet. The guideline contains five steps that include: 1) Determine how long the tourniquet has been in place; 2) Evaluate for contraindications to tourniquet removal; 3) Prepare for tourniquet removal; 4) Release the tourniquet; and 5) Monitor and reassess the patient. CONCLUSION: These steps outlined will help emergency medicine clinicians appropriately evaluate and manage patients presenting with tourniquets in place. Tourniquet removal should be performed in a systematic manner with plans in place to immediately address complications.

The role of the American Society of anesthesiologists physical status classification in predicting trauma mortality and outcomes.

BACKGROUND: Trauma prediction scores such as Revised Trauma Score (RTS) and Trauma and Injury Severity Score (TRISS)) are used to predict mortality, but do not include comorbidities. We analyzed the American Society of Anesthesiologists physical status (ASA PS) for predicting mortality in trauma patients undergoing surgery. METHODS: This multicenter, retrospective study compared the mortality predictive ability of ASA PS, RTS, Injury Severity Score (ISS), and TRISS using a complete case analysis with mixed effects logistic regression. Associations with mortality and AROC were calculated for each measure alone and tested for differences using chi-square. RESULTS: Of 3,042 patients, 230 (8%) died. The AROC for mortality for TRISS was 0.938 (95%CI 0.921, 0.954), RTS 0.845 (95%CI 0.815, 0.875), and ASA PS 0.886 (95%CI 0.864, 0.908). ASA PS + TRISS did not improve mortality predictive ability (p = 0.18). CONCLUSIONS: ASA PS was a good predictor of mortality in trauma patients, although combined with TRISS it did not improve predictive ability.

Impact of the Affordable Care Act on trauma and emergency general surgery: An Eastern Association for the Surgery of Trauma systematic review and meta-analysis.

BACKGROUND: Trauma and emergency general surgery (EGS) patients who are uninsured have worse outcomes as compared with insured patients. Partially modeled after the 2006 Massachusetts Healthcare Reform (MHR), the Patient Protection and Affordable Care Act was passed in 2010 with the goal of expanding health insurance coverage, primarily through state-based Medicaid expansion (ME). We evaluated the impact of ME and MHR on outcomes for trauma patients, EGS patients, and trauma systems. METHODS: This study was approved by the Eastern Association for the Surgery of Trauma Guidelines Committee. Using Grading of Recommendations Assessment, Development and Evaluation methodology, we defined three populations of interest (trauma patients, EGS patients, and trauma systems) and identified the critical outcomes (mortality, access to care, change in insurance status, reimbursement, funding). We performed a systematic review of the literature. Random effect meta-analyses and meta-regression analyses were calculated for outcomes with sufficient data. RESULTS: From 4,593 citations, we found 18 studies addressing all seven predefined outcomes of interest for trauma patients, three studies addressing six of seven outcomes for EGS patients, and three studies addressing three of eight outcomes for trauma systems. On meta-analysis, trauma patients were less likely to be uninsured after ME or MHR (odds ratio, 0.49; 95% confidence interval, 0.37-0.66). These coverage expansion policies were not associated with a change in the odds of inpatient mortality for trauma (odds ratio, 0.96; 95% confidence interval, 0.88-1.05). Emergency general surgery patients also experienced a significant insurance coverage gains and no change in inpatient mortality. Insurance expansion was often associated with increased access to postacute care at discharge. The evidence for trauma systems was heterogeneous. CONCLUSION: Given the evidence quality, we conditionally recommend ME/MHR to improve insurance coverage and access to postacute care for trauma and EGS patients. We have no specific recommendation with respect to the impact of ME/MHR on trauma systems. Additional research into these questions is needed. LEVEL OF EVIDENCE: Review, Economic/Decision, level III.

Significant Reduction of Pulmonary Embolism in Orthopaedic Trauma Patients.

OBJECTIVES: To report results of a protocol to lessen incidence of pulmonary embolism (PE) among orthopaedic trauma patients. DESIGN: Retrospective review. SETTING: Level 1 trauma center. PATIENT/PARTICIPANTS: Orthopaedic trauma inpatients were included in the study. INTERVENTION: On arrival, an orthopaedic trauma patient's PE risk is calculated using a previously developed tool. If possible, patients at high risk are given their first dose of enoxaparin before leaving the emergency room. If other injuries preclude enoxaparin, then chemoprophylaxis is held for 24 hours. Twenty-four hours after arrival, the patient's ability to receive enoxaparin is reassessed. If possible, enoxaparin is started, with dosing twice a day. If enoxaparin is still contraindicated, a removable inferior vena cava filter is placed. Adequacy of enoxaparin dosing is tested using anti-factor Xa assay, drawn 4 hours after the third dose of enoxaparin. If the anti-factor Xa result is less than 0.2 IU/mL, a removable inferior vena cava filter is placed. If the result is 0.2-0.5 IU/mL, enoxaparin dosing is continued. If greater than 0.5 IU/mL, the dose of enoxaparin is reduced. OUTCOME MEASURE: The main outcome measure was rate of PE. RESULTS: From September 1, 2015 to December 31, 2015, our hospital admitted 420 orthopaedic trauma patients. Fifty-one patients were classed as high risk for PE. In September through December 2015, 9 sustained PE, 1 of which was fatal. From September 1, 2016 to December 31, 2016, our hospital admitted 368 orthopaedic trauma patients with comparable age and Injury Severity Score to 2015. Forty patients were at high risk for PE, 1 sustained a nonfatal PE. PE incidence from September to December 2016 was significantly lower than in 2015 (P = 0.02). Overall, 26 patients managed under the new protocol had IVCFs placed, 21 had their filters removed, and 3 died with filters in place. There were no complications during filter placement or removal. One patient had hemorrhage felt to be attributable to enoxaparin. CONCLUSIONS: Our protocol emphasizes more robust enoxaparin dosing, and more frequent use of IVCF, but only among those at high risk. We lessened the incidence of PE, with a low complication rate. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A comparison of cholecystitis grading scales.

BACKGROUND: Previously, our group developed the Parkland grading scale for cholecystitis (PGS) to stratify gallbladder (GB) disease severity that can be determined immediately when performing laparoscopic cholecystectomy (LC). In prior studies, PGS demonstrated excellent interrater reliability and was internally validated as an accurate measure of LC outcomes. Here, we compare PGS against a more complex cholecystitis severity score developed by the national trauma society, American Association for the Surgery of Trauma (AAST), which requires clinical, operative, imaging, and pathologic inputs, as a predictor of LC outcomes. METHODS: Eleven acute care surgeons prospectively graded 179 GBs using PGS and filled out a postoperative questionnaire regarding the difficulty of the surgery. Three independent raters retrospectively graded these GBs using PGS from images stored in the electronic medical record. Three additional surgeons then assigned separate AAST scores to each GB. The intraclass correlation coefficient statistic assessed rater reliability for both PGS and AAST. The PGS score and the median AAST score became predictors in separate linear, logistic, and negative binomial regression models to estimate perioperative outcomes. RESULTS: The average intraclass correlation coefficient of PGS and AAST was 0.8647 and 0.8341, respectively. Parkland grading scale for cholecystitis was found to be a superior predictor of increasing operative difficulty (R, 0.566 vs. 0.202), case length (R, 0.217 vs. 0.037), open conversion rates (area under the curve, 0.904 vs. 0.757), and complication rates (area under the curve, 0.7039 vs. 0.6474) defined as retained stone, small-bowel obstruction, wound infection, or postoperative biliary leak. Parkland grading scale for cholecystitis performed similar to AAST in predicting partial cholecystectomy, readmission, bile leak rates, and length of stay. CONCLUSION: Both PGS and AAST are accurate predictors of LC outcomes. Parkland grading scale for cholecystitis was found to be a superior predictor of subjective operative difficulty, case length, open conversion rates, and complication rates. Parkland grading scale for cholecystitis has the advantage of being a simpler, operative-based scale which can be scored at a single point in time. LEVEL OF EVIDENCE: Single institution, retrospective review, level IV.

Prospective validation of the Parkland Grading Scale for Cholecystitis.

BACKGROUND: The Parkland Grading Scale for Cholecystitis (PGS) was developed as an intraoperative grading scale to stratify gallbladder (GB) disease severity during laparoscopic cholecystectomy (LC). We aimed to prospectively validate this scale as a measure of LC outcomes. METHODS: Eleven surgeons took pictures of and prospectively graded the initial view of 317 GBs using PGS while performing LC (LIVE) between 9/2016 and 3/2017. Three independent surgeon raters retrospectively graded these saved GB images (STORED). The Intraclass Correlation Coefficient (ICC) statistic assessed rater reliability. Fisher's Exact, Jonckheere-Terpstra, or ANOVA tested association between peri-operative data and gallbladder grade. RESULTS: ICC between LIVE and STORED PGS grades demonstrated excellent reliability (ICC = 0.8210). Diagnosis of acute cholecystitis, difficulty of surgery, incidence of partial and open cholecystectomy rates, pre-op WBC, length of operation, and bile leak rates all significantly increased with increasing grade. CONCLUSIONS: PGS is a highly reliable, simple, operative based scale that can accurately predict outcomes after LC. TABLE OF CONTENTS SUMMARY: The Parkland Grading Scale for Cholecystitis was found to be a reliable and accurate predictor of laparoscopic cholecystectomy outcomes. Diagnosis of acute cholecystitis, surgical difficulty, incidence of partial and open cholecystectomy rates, pre-op WBC, operation length, and bile leak rates all significantly increased with increasing grade.

2019 Recommended Limb Tourniquets in Tactical Combat Casualty Care.

Military and civilian trauma can be distinctly different but the leading cause of preventable trauma deaths in the prehospital environment, extremity hemorrhage, does not discriminate. The current paper is the most comprehensive review of limb tourniquets employable in the tactical combat casualty care environment and provides the first update to the CoTCCC-recommended limb tourniquets since 2005. This review also highlights the lack of unbiased data, official reporting mechanisms, and official studies with established criteria for evaluating tourniquets. Upon review of the data, the CoTCCC voted to update the recommendations in April 2019.

Post-Mortem Evaluation of Potentially Survivable Hemorrhagic Death in a Civilian Population.

BACKGROUND: Although the survivability of military extremity hemorrhage is well documented, equivalent civilian data are limited. We analyzed statewide autopsy records in Maryland to determine the number of hemorrhagic deaths that might have been potentially survivable with prompt hemorrhage control. Similar analyses of battlefield deaths led to life-saving changes in military medical practice. STUDY DESIGN: This is a retrospective study of decedent records. The objective is to estimate the number of hemorrhagic deaths that might have been prevented by prompt placement of an extremity tourniquet. Maryland autopsy records from 2002 to 2016 were selected using the following search terms: amputation, arm/arms, avulsion, exsanguination, extremity/extremities, leg/legs. The records were analyzed by applying a checklist of previously developed military criteria to characterize deaths as potentially survivable or nonsurvivable with prompt use of a tourniquet. Suicides and decedents less than 18 years old were excluded. The study did not use information about living participants. Two expert reviewers independently evaluated and scored the death records. Deaths were classified as either potentially survivable or nonsurvivable. A third reviewer broke any ties. RESULTS: There were 288 full autopsy records included in the final analysis. Of the eligible decedents reviewed during the 14-year period, 124 of 288 had potentially survivable wounds; 164 had nonsurvivable wounds. CONCLUSIONS: Over the 14-year study interval, 124 Maryland decedents-an average of 9 per year-might have been saved with prompt placement of a tourniquet. If extrapolated, approximately 480 people in the US might be saved per year. These results provide evidence to support educating and equipping the public to provide bleeding control.

Trauma and emergency general surgery patients should be extubated with an open abdomen.

BACKGROUND: Open abdomen (OA) and temporary abdominal closure (TAC) are common techniques to manage several surgical problems in trauma and emergency general surgery (EGS). Patients with an OA are subjected to prolonged mechanical ventilation. This can lead to increased rates of ventilator-associated pneumonia (VAP). We hypothesized that patients who were extubated with an OA would have a decrease in ventilator hours and as a result would have a lower rate of VAP without an increase in extubation failures. METHODS: A retrospective review was performed of all trauma and EGS patients managed at our institution with OA and TAC from January 2014 to February 2016. Patients were divided into cohorts consisting of those who were successfully extubated with an OA and those who were not. The number of extubation events and ventilator-free hours were calculated for each patient. Adverse events such as the need for reintubation with an OA and VAP were collected. RESULTS: Fifty-two patients (20 trauma, 32 EGS) were managed with an OA and TAC during the study period. Twenty-five patients (6 trauma, 19 EGS) had at least one extubation event with an OA. Median extubation events per patient was 3 (interquartile range, 1-5). The median ventilator-free hours for patients who were extubated was 101 hours (interquartile range, 39.42-260.46). Patients that were never extubated with an OA had higher rates of VAP (30.8% vs. 3.8%, p = 0.01). CONCLUSION: This study provides much needed data regarding the feasibility of extubation in trauma and EGS patients managed with an OA and TAC. Benefits of early extubation may include lower VAP rates in this population. Plans for reexploration hinder the decision to extubate in these patients. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Inability to predict subprophylactic anti-factor Xa levels in trauma patients receiving early low-molecular-weight heparin.

BACKGROUND: Standard low-molecular-weight heparin dosing may be suboptimal for venous thromboembolism prophylaxis. We aimed to identify independent predictors of subprophylactic Xa (subXa) levels in trauma patients treated under a novel early chemoprophylaxis algorithm. METHODS: A retrospective analysis of trauma patients from July 2016 to June 2017 who received enoxaparin 40 mg twice daily and had peak Xa levels drawn was performed. Patients were divided into cohorts based on having a subXa (<0.2 IU/mL) or prophylactic (≥0.2 IU/mL) Xa level. RESULTS: In all, 124 patients were included, of which 38 (31%) had subXa levels, and 17 (14%) had Xa levels greater than 0.4 IU/mL. Of the subXa cohort, 35 (92%) had their dosage increased, and the repeat Xa testing that was done in 32 revealed that only 75% reached prophylactic levels. The median time to the initiation of chemoprophylaxis was 21.9 hours (interquartile range [IQR], 11.45-35.07 hours). Patients who were defined as having lower risk of having a complication as a result of bleeding had a shorter time to starting prophylaxis than those at higher risk (18.39 hours [IQR 5.76-26.51 hours] vs. 29.5 hours [IQR 16.23-63.07 hours], p < 0.01).There was no difference in demographics, weight, body mass index, creatinine, creatinine clearance, injury severity score, type of injury, weight-based dose, time to chemoprophylaxis, or bleeding complications between the cohorts. No independent predictors of subXa level were identified on multivariable logistic regression. CONCLUSIONS: A significant number of trauma patients fail to achieve prophylactic Xa levels. Intrinsic factors may prevent adequate prophylaxis even with earlier administration and higher dosing of low-molecular-weight heparin. LEVEL OF EVIDENCE: Therapeutic, level IV.

Laparoscopic Appendectomy: A Report on 1164 Operations at a Single-Institution, Safety-Net Hospital.

Laparoscopic appendectomy (LA) is the standard of care for the treatment of acute appendicitis. There is an ongoing debate regarding the optimal management of appendicitis, which led us to study outcomes after an appendectomy at a large safety-net hospital. We hypothesize that despite a high-risk population, LA remains a safe and effective treatment for acute appendicitis. A retrospective review was performed of all patients who underwent an appendectomy from 2011 to 2013. The primary end point was significant morbidity defined as a score of three or greater on the Clavien-Dindo scale of surgical morbidity. Thousand hundred and sixty-four patients underwent an appendectomy. A total of 1102 (94.7%) patients underwent either an LA or laparoscopic converted to open appendectomy, and 62 (5.3%) patients underwent an open appendectomy (OA). Two hundred and forty six patients (21.1%) had complicated appendicitis. Laparoscopic converted to OA conversion rate was 4.4 per cent and differed between years (P < 0.001). LA had a significantly shorter length of stay, shorter length of postoperative antibiotics, and less postoperative morbidity. When limited to only patients with complicated appendicitis, major morbidity was still greater in the OA group (22.6 vs 52.0%, P = 0.001). Length of stay was significantly longer in the OA group [3.42 (2.01, 5.97) vs 7.04 (5.05, 10.13), P < 0.001]. Odds for complication were 2.6 times greater in the OA group compared with the LA group. In the absence of peritonitis and systemic illness necessitating urgent laparotomy, patients who are laparoscopic surgical candidates should be offered an LA. Our study demonstrates that these patients have better outcomes and shorter hospital stays.

Determining suicide risk in trauma patients using a universal screening program.

BACKGROUND: Trauma patients may be at elevated risk for subsequent suicide; however, it is unclear whether patients at risk can be identified during their initial presentation following injury. The objectives of this study were to evaluate the use of a standardized clinical decision support system for suicide risk screening developed by our hospital system and to determine the incidence of positive suicide screenings in our trauma population. METHODS: Adult trauma patient screenings were performed by nursing staff during the triage process using the Columbia Suicide Severity Rating Scale, Clinical Practice Screener, Recent (C-SSRS). Adult trauma patients who had a suicide risk screening completed from February 2015 to November 2015 were evaluated retrospectively. Patients were divided into cohorts consisting of those with positive and negative screening assessments. Significance was set at α = 0.05. Statistical analysis was performed using Student t test and a χ test where appropriate. RESULTS: Overall, 3,623 of 3,712 patients (98%) completed a suicide risk screening during the study period. Those who went unscreened were not evaluated due to altered mental status/intubation/emergent surgery (97%), death (1%), or an unwillingness to cooperate (2%). The suicide risk screening result was positive in 161 of 3,623 patients (4%) in the study cohort. On univariate analysis, patients with a positive suicide risk screen result were more likely to be white (43% vs 32%; p = 0.01), identify English as their primary language (91% vs 73%; p < 0.01), have insurance coverage (48% vs 28%; p < 0.01), and were more likely to initiate a low-level trauma activation (27% vs 16%; p <0.01) than those who had a negative screening result. A positive suicide risk assessment result was moderately associated with patients of white race (odds ratio, 1.83; 95% confidence interval, 1.27-2.65) on multivariable logistic regression. CONCLUSION: Our universal suicide screening process identifies an at-risk subpopulation of trauma patients. LEVEL OF EVIDENCE: Prognostic study, level III; therapeutic, level IV.

The Eastern Association for the Surgery of Trauma's Injury Control and Violence Prevention Committee's annual distracted driving outreach event: Evaluating attitude and behavior change in high school students.

BACKGROUND: The National Center for Statistics and Analysis reports at least eight deaths and 1,160 daily injuries due to distracted driving (DD) in the United States. Drivers younger than 20 years are most likely to incur a distraction-related fatal crash. We aimed to determine short- and long-term impact of a multimodal educational program including student-developed interventions, simulated driving experiences, and presentations by law enforcement and medical personnel. METHODS: A single-day program aimed at teen DD prevention was conducted at a high school targeting students aged 15 years to 19 years old. Students were surveyed before, after, and at 6 weeks. We surveyed age, gender, knowledge, and experience regarding DD. Summary statistics were obtained at each survey time point. Bivariate and multivariable analysis were conducted to assess whether change in responses varied over time points. Multivariable models were adjusted for sex and urban and rural driving. RESULTS: Preintervention, postintervention, and 6-week follow-up surveys were completed by 359, 272 (76%), and 331 (92%) students, respectively. At baseline and 6-week follow-up, the most frequent passenger-reported DD behaviors were cell phone (63% [63% at follow-up) and radio use (61% [63%]). Similarly, the most frequent driver-reported DD behaviors were cell phone (68% [72%]) and radio use (79% [80%]). When students were asked, "How likely are you to use your cell phone while driving?" they answered "never" 35%, 70%, and 46% on the preintervention, postintervention, and 6-week surveys. They were less likely to report consequences to be worse or change in attitude to a great extent at 6 weeks (p < 0.01). Gender and urban or rural driving were not significantly associated with responses. CONCLUSIONS: While DD education may facilitate short-term knowledge and attitude changes, there appears to be no lasting effect. Research should be focused toward strategies for longer-term impact. LEVEL OF EVIDENCE: Therapeutic study, level II.

The Parkland grading scale for cholecystitis.

BACKGROUND: Gallbladders (GBs) with severe inflammation have longer operative times and an increased risk for complications. We propose a grading system using intraoperative images to better stratify GB inflammation. METHODS: After reviewing the intraoperative images of GBs obtained during several hundred laparoscopic cholecystectomies, we developed a five-tiered grading system based on anatomy and inflammatory changes. Fifty intraoperative photographs were taken prior to dissection and then distributed to 11 surgeons who rated each GB's severity per the grading system. The two-way random effects Intraclass Correlation Coefficient (ICC) was used to assess the reliability among the raters. RESULTS: The ICC among the raters of GB severity was 0.804 (95% CI: 0.733 to 0.867; p = 0.0001). Nineteen GB images had greater than 82% agreement and 16 were clustered around GBs with severe inflammation (grades 3-5). CONCLUSION: This study proposes a simple, reliable grading system that characterizes GB complexity based on inflammation and anatomy.