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Trauma is the leading cause of death and disability in patients aged 1-46 y. Severely injured patients experience considerable blood loss and hemorrhagic shock requiring treatment with massive transfusion of red blood cells (RBCs). Preclinical and retrospective human studies in trauma patients have suggested that poorer therapeutic efficacy, increased severity of organ injury, and increased bacterial infection are associated with transfusion of large volumes of stored RBCs, although the mechanisms are not fully understood. We developed a murine model of trauma hemorrhage (TH) followed by resuscitation with plasma and leukoreduced RBCs (in a 1:1 ratio) that were banked for 0 (fresh) or 14 (stored) days. Two days later, lungs were infected with Pseudomonas aeruginosa K-strain (PAK). Resuscitation with stored RBCs significantly increased the severity of lung injury caused by P. aeruginosa, as demonstrated by higher mortality (median survival 35 h for fresh RBC group and 8 h for stored RBC group; p < 0.001), increased pulmonary edema (mean [95% CI] 106.4 μl [88.5-124.3] for fresh RBCs and 192.5 μl [140.9-244.0] for stored RBCs; p = 0.003), and higher bacterial numbers in the lung (mean [95% CI] 1.2 × 10(7) [-1.0 × 10(7) to 2.5 × 10(7)] for fresh RBCs and 3.6 × 10(7) [2.5 × 10(7) to 4.7 × 10(7)] for stored RBCs; p = 0.014). The mechanism underlying this increased infection susceptibility and severity was free-heme-dependent, as recombinant hemopexin or pharmacological inhibition or genetic deletion of toll-like receptor 4 (TLR4) during TH and resuscitation completely prevented P. aeruginosa-induced mortality after stored RBC transfusion (p < 0.001 for all groups relative to stored RBC group). Evidence from studies transfusing fresh and stored RBCs mixed with stored and fresh RBC supernatants, respectively, indicated that heme arising both during storage and from RBC hemolysis post-resuscitation plays a role in increased mortality after PAK (p < 0.001). Heme also increased endothelial permeability and inhibited macrophage-dependent phagocytosis in cultured cells. Stored RBCs also increased circulating high mobility group box 1 (HMGB1; mean [95% CI] 15.4 ng/ml [6.7-24.0] for fresh RBCs and 50.3 ng/ml [12.3-88.2] for stored RBCs), and anti-HMGB1 blocking antibody protected against PAK-induced mortality in vivo (p = 0.001) and restored macrophage-dependent phagocytosis of P. aeruginosa in vitro. Finally, we showed that TH patients, admitted to the University of Alabama at Birmingham ER between 1 January 2015 and 30 April 2016 (n = 50), received high micromolar-millimolar levels of heme proportional to the number of units transfused, sufficient to overwhelm endogenous hemopexin levels early after TH and resuscitation. Limitations of the study include lack of assessment of temporal changes in different products of hemolysis after resuscitation and the small sample size precluding testing of associations between heme levels and adverse outcomes in resuscitated TH patients. We provide evidence that large volume resuscitation with stored blood, compared to fresh blood, in mice increases mortality from subsequent pneumonia, which occurs via mechanisms sensitive to hemopexin and TLR4 and HMGB1 inhibition.

Background Hemorrhage is the most common cause of potentially preventable death after injury. Balanced transfusion with red blood cells, plasma, and platelets (component therapy, CT) has been shown to reduce mortality, and is the standard of care. Low-Titer Group O Whole Blood (LTOWB) is an attractive alternative to CT, but existing evidence comprises observational studies, and a small single center pilot randomized controlled trial, which evaluated a type of whole blood that is no longer in use. The aim of the “Trauma Resuscitation with Low-Titer Group O Whole Blood Or Products” (TROOP) trial is to compare the effectiveness and safety of LTOWB and CT in critically injured patients predicted to require a large volume transfusion. Methods This is a pragmatic, multicenter, Bayesian, sequential non-inferiority/superiority, randomized clinical trial, performed within 15 level I trauma centers in the United States. We aim to randomize 1,100 injured patients to resuscitation with either CT or LTOWB. The primary outcome is 6-h mortality. Secondary outcomes include 24-h and 30-day or hospital mortality (whichever is earlier); prespecified complications; adjudicated cause of death; time to death; length of stay (ICU and hospital); and hospital-, ventilator- and ICU-free days; the incidence of major surgical procedures; time to hemostasis in those undergoing procedures with a hemostatic component; number and type of blood products used until hemostasis is achieved (and randomized products are discontinued), as well as after hemostasis has been achieved, to 24 h post-admission; discharge destination and functional status and quality of life at hospital discharge or 30 days, as measured by Glasgow Coma Scale (GCS) and EuroQol (EQ-5D) quality of life measurement. Discussion This large multicenter clinical trial will contribute high-level evidence on the effectiveness of Low-Titer Group O Whole Blood in the in-hospital management of trauma patients predicted to require a large volume transfusion. Trial registration National Clinical Trial Identified Number: NCT05638581. Clinical trial registry: https://clinicaltrials.gov/study/NCT05638581 First submitted 2022–11-08.

Despite their wide use, whether antiarrhythmic drugs improve survival after out-of-hospital cardiac arrest (OHCA) is not known. The ROC-ALPS is evaluating the effectiveness of these drugs for OHCA due to shock-refractory ventricular fibrillation or pulseless ventricular tachycardia (VF/VT). ALPS will randomize 3,000 adults across North America with nontraumatic OHCA, persistent or recurring VF/VT after ≥1 shock, and established vascular access to receive up to 450 mg amiodarone, 180 mg lidocaine, or placebo in the field using a double-blind protocol, along with standard resuscitation measures. The designated target population is all eligible randomized recipients of any dose of ALPS drug whose initial OHCA rhythm was VF/VT. A safety analysis includes all randomized patients regardless of their eligibility, initial arrhythmia, or actual receipt of ALPS drug. The primary outcome of ALPS is survival to hospital discharge; a secondary outcome is functional survival at discharge assessed as a modified Rankin Scale score ≤3. The principal aim of ALPS is to determine if survival is improved by amiodarone compared with placebo; secondary aim is to determine if survival is improved by lidocaine vs placebo and/or by amiodarone vs lidocaine. Prioritizing comparisons in this manner acknowledges where differences in outcome are most expected based on existing knowledge. Each aim also represents a clinically relevant comparison between treatments that is worth investigating. Results from ALPS will provide important information about the choice and value of antiarrhythmic therapies for VF/VT arrest with direct implications for resuscitation guidelines and clinical practice.

ObjectivesFollowing up trauma patients after discharge, to evaluate their subsequent quality of life and functional outcomes, is notoriously difficult, time consuming, and expensive. Automated systems are a conceptually attractive solution. We prospectively assessed the feasibility of using a series of automated phone calls administered by Emmi Patient Engagement to survey trauma patients after discharge.MethodsRecruitment into the study was incorporated into the patient discharge process by nursing staff. For this pilot, we included trauma patients discharging home and who were able to answer phone calls. A script was created to evaluate the Extended Glasgow Outcome Scale and the EuroQol EQ-5D to assess functional status and quality of life, respectively. Call attempts were made at 6 weeks, 3 months, 6 months, and 1 year after discharge.ResultsA total of 110 patients initially agreed to participate. 368 attempted patient encounters (calls or attempted calls) took place, with 104 (28.3%) patients answering a least one question in the study. 21 unique patients (19.1% of those enrolled) completed 27 surveys.ConclusionsAutomated, scripted phone calls to survey patients after discharge are not a feasible way of collecting functional and quality of life data.Level of evidenceLevel II/prospective.

Slope was significantly non-zero for number of units (r2 = 0.91, p<0.001). https://doi.org/10.1371/journal.pmed.1002991.g001 In the Results, in the subsection “Heme levels in patients after TH and resuscitation”, there is an error in the fifth sentence of the first paragraph. While the absolute concentration of these mediators is important, the relative concentrations of hemoglobin and free heme, compared to Hp and Hpx respectively is likely of greater clinical significance; Hp and Hpx are the endogenous primary defense mechanisms protecting against hemolysis-dependent injury. (2018) Role of heme in lung bacterial infection after trauma hemorrhage and stored red blood cell transfusion: A preclinical experimental study.

Background‘Community consultation’ (CC) is a key step when conducting Exception From Informed Consent research. Social-media-based CC has been shown to reach more people than traditional methods, but it is unclear whether those reached are representative of the community as a whole.MethodsThis is a retrospective analysis of the CC performed in preparation for the PHOXSTAT trial. Social media advertisement campaigns were conducted in the catchment areas of the three participating trauma centers and evaluated by examining Facebook user statistics. We compared these data to georeferenced population data obtained from the U.S. Census Bureau. We examined variations in the proportion of each age group reached, by gender.ResultsOur social media advertisements reached a total of 332 081 individuals in Los Angeles, Birmingham, and Nashville. Although there were differences in the proportion of individuals reached within each age group and gender groups, compared with the population in each area, these were small (within 5%). In Birmingham, participants 55 to 64 years old, 25 to 34 years old, and females 18 to 24 years old were slightly over-represented (a larger proportion of individuals in this age group were reached by the social media campaign, compared with the population resident in this area). In contrast, in Nashville, female participants 45 to 64 years old, and males 25 to 64 years old were over-represented. In Los Angeles, females 45 to 64 years old, and males 25 to 64 years and over were over-represented.DiscussionIn conclusion, this study demonstrates that social media CC campaigns can be used to reach a sample of the community broadly representative of the population as a whole, in terms of age and gender. This finding is helpful to IRBs and investigators, as it lends further support to the use of social media to conduct CC. Further work is needed to analyze how representative community samples are in terms of other characteristics, such as race, ethnicity, and socioeconomic status.Level III evidenceEconomic & Value-based Evaluations.

BackgroundTrauma is a major public health issue. In 2015, the White House launched the “Stop the Bleed” (STB) campaign, which aims to equip would-be bystanders with the ability and equipment to assist in bleeding emergencies. This study sought to estimate the number of patients who might benefit from STB intervention, in an everyday setting, and their spatial injury profile.MethodsThis is a retrospective analysis of trauma registry and medical examiners’ data, collected between 2013 and 2017. The majority of patients were male. The median age was 32 years. Incidents were geocoded by ZIP code, and mapped using Quantum Geographic Information System (QGIS).ResultsWe identified 139 patients from medical examiner records and UAB’s trauma registry who might have benefitted from STB intervention. The number of incidents per year ranged from 22 to 35, averaging 2.3 incidents per month. There was no evidence of geographical clustering, although the small number of incidents precluded a formal geostatistical analysis.ConclusionThe number of patients who might benefit from STB interventions on a daily basis is small, and incident locations are difficult to predict. Educating the public in how to stop bleeding is appealing, but providing easy and widespread access to STB kits may be difficult. Although there are parallels to the provision of cardiopulmonary resuscitation and defibrillation for cardiac arrest, there are also differences, which should not be overlooked.

Patients with out-of-hospital cardiac arrest were assigned to the use of either an impedance threshold device (ITD) or a sham ITD. There was no significant difference between the two groups in survival to hospital discharge with satisfactory functional status. Standard cardiopulmonary resuscitation (CPR), defined as manual chest compressions with rescue breathing, can be lifesaving but provides only a relatively small fraction of normal cardiac output, even when performed correctly. 1 , 2 One proposed strategy to augment cardiac output during CPR is the use of an impedance threshold device (ITD). 3 – 5 The ITD is designed to enhance venous return and cardiac output during CPR by increasing the degree of negative intrathoracic pressure (Fig. 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). This effect is achieved by preventing the passive inflow of air into the chest . . .

The aim of this study was to compare the impact of different flight path models on the calculated population coverage of aeromedical retrieval systems, using the state of Alabama as a case study. Geospatial analysis of U.S. Census Bureau population data using helicopter bases and trauma centers as foci of either circular or elliptical coverage areas. Circular isochrone models around helicopter bases or trauma centers suggest that the entire population of Alabama could reach a level I or II trauma center within 60 min. Elliptical isochrones, incorporating outbound and inbound flights, suggest that only 78.8% of the population have ready access to level I or II trauma centers. While all three flight path models described have some validity and utility, simplistic circular flight time isochrones around trauma centers and helicopter bases provide overly optimistic estimates of population coverage. The elliptical model provides a more realistic evaluation. •Accessibility of trauma services is often measured in terms of population coverage.•This study shows that the flight path model has a major impact on population coverage.•Simple models suggest 100% of Alabama residents have access to trauma care by air.•More complex models suggest that only around three-quarters of residents have access.•Harmonizing the reporting of air medical system coverage should be considered. Simplistic circular flight time isochrones around trauma centers and helicopter bases provide overly optimistic estimates of population coverage. Using the ellipse model, including allowance for mission ground time, provides a more realistic assessment.

Purpose To evaluate the feasibility of enrolling patients in a randomized controlled trial (RCT) comparing endovascular coils (EC) and vascular plugs (VP) for proximal splenic artery embolization (pSAE) in high-grade splenic trauma, and to collect data to inform the design of a larger clinical effectiveness trial. Methods Single-center, prospective, RCT of patients with Grade III–V splenic injuries selected for nonoperative management. Patients were randomized to pSAE with EC or VP. The main outcome was feasibility. We also evaluated technical success, time to stasis, complications, mortality, and splenectomy rates, by estimating rates and 95% confidence intervals. Results 46 of 50 eligible patients were enrolled (92%, 95% CI 90–100%). Overall, splenic salvage was 98% (45/46; 95% CI 94–100%). Primary technical success was observed in 22 EC patients (96%; 95% CI 87–100%) and 20 VP patients (87%; 95% CI 73–100%). Bayesian analysis suggests a > 80% probability that primary technical success is higher for EC. Two complications (one major and one minor) occurred in the EC group (9%; CI 0–20%) and one major complication occurred in the VP group (4%; CI 0–13%). Conclusions Randomized comparisons of endovascular devices used for pSAE after trauma are feasible. pSAE using either EC or VP results in excellent rates of splenic salvage in trauma patients with high-grade splenic injuries. These high rates of splenic salvage and low rates of complications make their use as a primary outcome in a future trial problematic. Consideration should be given to technical parameters as a primary outcome for future trials.