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.

Hemolytic markers following the transfusion of uncrossmatched, cold-stored, low-titer, group O+ whole blood in civilian trauma patients.

BACKGROUND: Low-titer group O whole blood (LTOWB) is increasingly being used in the civilian trauma setting, although there is a risk of hemolysis. This study evaluated the impact on hemolytic markers following the transfusion of 4 or more units of uncrossmatched LTOWB. METHODS: Civilian adult trauma patients who received four or more units of leukoreduced group O+, low-titer (<50 anti-A and anti-B), platelet-replete uncrossmatched whole blood during their initial resuscitation and who survived for more than 24 hours after the transfusion were included in this retrospective study. Lactate dehydrogenase (LDH), total bilirubin, haptoglobin, potassium, and creatinine were evaluated on the day of LTOWB transfusion (Day 0) and the next 3 days. Blood product administration over the first 24 hours of admission was recorded. RESULTS: There were 54 non-group O and 23 group O recipients of four or more LTOWB units. The median (interquartile range [IQR]) number of transfused LTOWB units was 4 (4-5) and 4 (4-4), respectively, the maximum number in both groups was eight. The non-group O patients received a median (IQR) volume of 1470 mL (1368-2052) of ABO-incompatible plasma. Comparing the non-group O to the group O recipients, there were no significant differences in the haptoglobin, LDH, total bilirubin, potassium, or creatinine concentrations at any of the time points. There were no reported transfusion reactions. CONCLUSION: Receiving at least four LTOWB units was not associated with biochemical or clinical evidence of hemolysis.

Opioid use patterns and risk characteristics among injured patients.

Background: Injured patients are at risk for prolonged opioid use after discharge from care. Limited evidence exists regarding how continued opioid use may be related to opioid medication misuse and opioid use disorder (OUD) following injury. This pilot study characterized opioid consumption patterns, health characteristics, and substance use among patients with active prescriptions for opioid medications following injury care. Methods: This study was a cross-sectional screening survey combined with medical record review from February 2017 to March 2018 conducted among outpatient trauma and orthopedic surgery clinic patients. Eligible patients were 18-64 years of age, admitted/discharged for an injury or trauma-related orthopedic surgery, returning for clinic follow-up ≤6 months post hospital discharge after the index injury, prescribed opioid pain medication at discharge, and currently taking an opioid medication (from discharge or a separate prescription post discharge). Data collected included demographic, substance use, mental health, and physical health information. Descriptive and univariate statistics were calculated to characterize the population and opioid-related risks. Results: Seventy-one participants completed the survey (92% response). Most individuals (≥75%) who screened positive for misuse or OUD reported no nonmedical/illicit opioid use in the year before the index injury. A positive depression screen was associated with a 3.88 times increased likelihood for misuse or OUD (95% confidence interval [CI] = 1.1-13.5). Nonopioid illicit drug use (odds ratio [OR] = 1.89, 95% CI = 1.1-3.4) and opioid craving (OR = 1.29, 95% CI = 1.1-1.5) were also associated with increased likelihood for misuse or OUD. Number of emergency department visits in the 3 years previous to the index injury was associated with a 22% likelihood of being misuse or OUD positive (95% CI = 1.0-1.5). Conclusions: Patients with behavioral health concerns and greater emergency department utilization may have heightened risk for experiencing adverse opioid-related outcomes. Future research must further establish these findings and possibly develop protocols to identify patients at risk prior to pain management planning.

Cervical Spine Fractures: Who Really Needs CT Angiography?

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Compare a novel two-step algorithm for indicating a computed tomography angiography (CTA) in the setting of a cervical spine fracture with established gold standard criteria. SUMMARY OF BACKGROUND DATA: As CTA permits the rapid detection of blunt cerebrovascular injuries (BCVI), screening criteria for its use have broadened. However, more recent work warns of the potential for the overdiagnosis of BCVI, which must be considered with the adoption of broad criteria. METHODS: A novel two-step metric for indicating CTA screening was compared with the American College of Surgeons guidelines and the expanded Denver Criteria using patients who presented with cervical spine fractures to a tertiary-level 1 trauma center from January 1, 2012 to January 1, 2016. The ability for each metric to identify BCVI and posterior circulation strokes that occurred during this period was assessed. RESULTS: A total of 721 patients with cervical fractures were included, of whom 417 underwent CTAs (57.8%). Sixty-eight BCVIs and seven strokes were diagnosed in this cohort. All algorithms detected an equivalent number of BCVIs (52 with the novel metric, 54 with the ACS and Denver Criteria, P = 0.84) and strokes (7/7, 100% with the novel metric, 6/7, 85.7% with the ACS and Denver Criteria, P = 1.0). However, 63% fewer scans would have been needed with the proposed screening algorithm compared with the ACS or Denver Criteria (261/721, 36.2% of all patients with our criteria vs. 413/721, 57.3% with the ACS standard and 417/721, 57.8%) with the Denver Criteria, P < 0.0002 for each). CONCLUSION: A two-step criterion based on mechanism of injury and patient factors is a potentially useful guide for identifying patients at risk of BCVI and stroke after cervical spine fractures. Further prospective analyses are required prior to widespread clinical adoption. LEVEL OF EVIDENCE: 4.

Clinical outcomes among low-titer group O whole blood recipients compared to recipients of conventional components in civilian trauma resuscitation.

BACKGROUND: The serological safety of transfusing ≤4 units of low titer group O whole blood (LTOWB) in civilian trauma patients has been demonstrated. This study investigated clinical outcomes of LTOWB recipients compared to patients who received only conventional blood components during their resuscitation. STUDY DESIGN AND METHODS: A retrospective analysis of trauma patients' medical records who received LTOWB during the first 24 hours of their admission was performed. Using a 12-parameter propensity matching strategy, LTOWB recipients were matched to other patients who received at least one red blood cell (RBC) unit during their first 24 hours of admission but not LTOWB. The primary outcomes were mortality and blood use. RESULTS: A total of 135 patients who received LTOWB (median 2 units) were matched to 135 patients who received conventional components. There were no significant differences in the matching parameters between the groups. There were no significant differences in outcomes between the conventional component and LTOWB groups: median (interquartile range) in-hospital mortality, 24.4% vs. 18.5% (respectively, p = 0.24); 24-hour mortality, 12.6% vs. 8.9% (respectively, p = 0.33). The hospital and intensive care unit lengths of stay were not significantly different between groups. The median number of RBC units transfused, including the contribution from the LTOWB, was not significantly different between the groups. The time to normalization of elevated plasma lactate levels tended to be shorter among the LTOWB recipients compared to the conventional component recipients (median 8.1 [3.7-15.4] hr vs. 13.2 [4.4-26.8] hr, respectively, p = 0.05). CONCLUSION: The LTOWB recipients had similar clinical outcomes compared to recipients of conventional component therapy.

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 .).

Safety profile of uncrossmatched, cold-stored, low-titer, group O+ whole blood in civilian trauma patients.

BACKGROUND: The use of cold-stored low-titer group O whole blood (LTOWB) for civilian trauma patients is gaining popularity. However, hemolysis might occur among non-group O recipients. This study evaluated the serologic safety of transfusing up to 4 units of LTOWB. STUDY DESIGN AND METHODS: Hypotensive male and at least 50-year-old female trauma patients who received leukoreduced, uncrossmatched, group O+, low-titer (<50 anti-A and anti-B), platelet-replete whole blood during initial resuscitation were included in this prospective, observational study. Biochemical markers of hemolysis were measured on the day of LTOWB receipt (Day 0) and over the next 2 days. Blood product administration in the first 24 hours of admission and reported transfusion-associated adverse events were also reviewed. RESULTS: There were 102 non-group O and 70 group O recipients of 1 to 4 LTOWB units analyzed. The non-group O recipients received a median volume of 600 mL (range, 300-4100 mL) of ABO-incompatible plasma, including the contribution from the LTOWB units. There were no significant differences in median haptoglobin, lactate dehydrogenase, total bilirubin, creatinine, or potassium levels at any time point between the non-group O and group O recipients. There were also no differences in these markers between the subset of 23 non-group O and 14 group O recipients who received 3 or 4 LTOWB units. No transfusion-associated adverse events were reported. CONCLUSIONS: Administration of up to 4 units of LTOWB in civilian trauma resuscitation was not associated with clinical or biochemical evidence of hemolysis. Six units per trauma patient are now permitted at these institutions.

Limitations of multidetector computed tomography angiography for the diagnosis of blunt cerebrovascular injury.

OBJECTIVE Blunt cerebrovascular injuries (BCVIs) following trauma carry risk for morbidity and mortality. Since patients with BCVI are often asymptomatic at presentation and neurological sequelae often occur within 72 hours, timely diagnosis is essential. Multidetector CT angiography (CTA) has been shown to be a noninvasive, cost-effective, reliable means of screening; however, the false-positive rate of CTA in diagnosing patients with BCVI represents a key drawback. Therefore, the authors assessed the role of DSA in the screening of BCVI when utilizing CTA as the initial screening modality. METHODS The authors performed a retrospective analysis of patients who experienced BCVI between 2013 and 2015 at 2 Level I trauma centers. All patients underwent CTA screening for BCVI according to the updated Denver Screening Criteria. Patients who were diagnosed with BCVI on CTA underwent confirmatory digital subtraction angiography (DSA). Patient demographics, screening indication, BCVI grade on CTA and DSA, and laboratory values were collected. Comparison of false-positive rates stratified by BCVI grade on CTA was performed using the chi-square test. RESULTS A total of 140 patients (64% males, mean age 50 years) with 156 cerebrovascular blunt injuries to the carotid and/or vertebral arteries were identified. After comparison with DSA findings, CTA findings were incorrect in 61.5% of vessels studied, and the overall CTA false-positive rates were 47.4% of vessels studied and 47.9% of patients screened. The positive predictive value (PPV) for CTA was higher among worse BCVI subtypes on initial imaging (PPV 76% and 97%, for BCVI Grades II and IV, respectively) compared with Grade I injuries (PPV 30%, p < 0.001). CONCLUSIONS In the current series, multidetector CTA as a screening test for blunt cerebrovascular injury had a high-false positive rate, especially in patients with Grade I BCVI. Given a false-positive rate of 47.9% with an estimated average of 132 patients per year screening positive for BCVI with CTA, approximately 63 patients per year would potentially be treated unnecessarily with antithrombotic therapy at a busy United States Level I trauma center. The authors' data support the use of DSA after positive findings on CTA in patients with suspected BCVI. DSA as an adjunctive test in patients with positive CTA findings allows for increased diagnostic accuracy in correctly diagnosing BCVI while minimizing risk from unnecessary antithrombotic therapy in polytrauma patients.

Emergency Surgical Airways Following Activation of a Difficult Airway Management Team in Hospitalized Critically Ill Patients: A Case Series.

INTRODUCTION: An emergency surgical airway (ESA) is widely recommended for securing the airway in critically ill patients who cannot be intubated or ventilated. Little is known of the frequency, clinical circumstances, management methods, and outcomes of hospitalized critically ill patients in whom ESA is performed outside the emergency department or operating room environments. METHODS: We retrospectively reviewed all adult patients undergoing ESA in our intensive care units (ICUs) and other hospital units from 2008 to 2012 following activation of our difficult airway management team (DAMT). RESULTS: Of 207 DAMT activations for native airway events, 22 (10.6%) events culminated in an ESA, with 59% of these events occurring in ICUs with the remainder outside the ICU in the context of rapid response team activations. Of patients undergoing ESA, 77% were male, 63% were obese, and 41% had a history of a difficult airway (DA). Failed planned or unplanned extubations preceded 61% of all ESA events in the ICUs, while bleeding from the upper or lower respiratory tract led to ESA in 44% of events occurring outside the ICU. Emergency surgical airway was the primary method of airway control in 3 (14%) patients, with the remainder of ESAs performed following failed attempts to intubate. Complications occurred in 68% of all ESAs and included bleeding (50%), multiple cannulation attempts (36%), and cardiopulmonary arrest (27%). Overall hospital mortality for patients undergoing ESA was 59%, with 38% of deaths occurring at the time of the airway event. CONCLUSION: An ESA is required in approximately 10% of DA events in critically ill patients and is associated with high morbidity and mortality. Efforts directed at early identification of patients with a difficult or challenging airway combined with a multidisciplinary team approach to management may reduce the overall frequency of ESA and associated complications.

Vascular Shunts in Civilian Trauma.

Experience with temporary intravascular shunts (TIVS) for vessel injury comes from the military sector and while the indications might be clear in geographically isolated and under resourced war zones, this may be an uncommon scenario in civilian trauma. Data supporting TIVS use in civilian trauma have been extrapolated from the military literature where it demonstrated improved life and limb salvage. Few non-comparative studies from the civilian literature have also revealed similar favorable outcomes. Still, TIVS placement in civilian vascular injuries is uncommon and by some debatable given the absence of clear indications for placement, the potential for TIVS-related complications, the widespread resources for immediate and definitive vascular repair, and the need for curtailing costs and optimizing resources. This article reviews the current evidence and the role of TIVS in contemporary civilian trauma management.

Delayed splenic vascular injury after nonoperative management of blunt splenic trauma.

BACKGROUND: Delayed splenic vascular injury (DSVI) is traditionally considered a rare, often clinically occult, harbinger of splenic rupture in patients with splenic trauma that are managed conservatively. The purpose of our study was to assess the incidence of DSVI and associated features in patients admitted with blunt splenic trauma and managed nonoperatively. MATERIALS AND METHODS: A retrospective analysis was conducted over a 4-y time. Patients admitted with blunt splenic trauma, managed no-operatively and with a follow-up contrast-enhanced computed tomography (CT) scan study during admission were included. The CT scans were reviewed for American Association for the Surgery of Trauma splenic injury score, amount of hemoperitoneum, and presence of DSVI. Logistic regression models were used to investigate the risk factors associated with DSVI. RESULTS: A total of 100 patients (60 men and 40 women) constituted the study group. Follow-up CT scan demonstrated a 23% incidence of DSVI. Splenic artery angiography validated DSVI in 15% of the total patient population. Most DSVIs were detected only on arterial phase CT scan imaging. The American Association for the Surgery of Trauma splenic injury score (odds ratio = 1.73; P = 0.045) and the amount of hemoperitoneum (odds ratio = 1.90; P = 0.023) on admission CT scan were associated with the development of DSVI on follow-up CT scan. CONCLUSIONS: DSVI on follow-up CT scan imaging of patients managed nonoperatively after splenic injury is common and associated with splenic injury score assessed on admission CT scan.

Surgical rescue: The next pillar of acute care surgery.

BACKGROUND: The evolving field of acute care surgery (ACS) traditionally includes trauma, emergency general surgery, and critical care. However, the critical role of ACS in the rescue of patients with a surgical complication has not been explored. We here describe the role of "surgical rescue" in the practice of ACS. METHODS: A prospective, electronic medical record-based ACS registry spanning January 2013 to May 2014 at a large urban academic medical center was screened by ICD-9 codes for acute surgical complications of an operative or interventional procedure. Long-term outcomes were derived from the Social Security Death Index. RESULTS: Of 2,410 ACS patients, 320 (13%) required "surgical rescue": most commonly, from wound complications (32%), uncontrolled sepsis (19%), and acute obstruction (15%). The majority of complications (85%) were related to an operation; 15% were related to interventional procedures. The most common rescue interventions required were bowel resection (23%), wound debridement (18%), and source control of infection (17%); 63% of patients required operative intervention, and 22% required surgical critical care. Thirty-six percent of complications occurred in ACS primary patients ("local"), whereas 38% were referred from another surgical service ("institutional") and 26% referred from another institution ("regional"). Hospital length of stay was longer, and in-hospital and 1-year mortalities were higher in rescue patients compared with those without a complication. Outcomes were equivalent between "local" and "institutional" patients, but hospital length of stay and discharge to home were significantly worse in "institutional" referrals. CONCLUSION: We here describe the distinct role of the acute care surgeon in the surgical management of complications; this is an additional pillar of ACS. In this vital role, the acute care surgeon provides crucial support to other providers as well as direct patient care in the "surgical rescue" of surgical and procedural complications. LEVEL OF EVIDENCE: Epidemiological study, level III; therapeutic/care management study, level IV.

Blood component transfusion and wastage rates in the setting of massive transfusion in three regional trauma centers.

BACKGROUND: The purpose of massive transfusion protocols (MTPs) is to provide large quantities of blood products rapidly to exsanguinating patients. The expected rates of blood product transfusion and wastage in this setting have not been defined. This study was undertaken to assess the transfusion and wastage rates for bleeding patients requiring emergency issue of blood components at three American Level I trauma centers. STUDY DESIGN AND METHODS: Three hospitals participated, all of which are Level I trauma centers that have MTPs in place where uncrossmatched red blood cells (RBCs) can be ordered with or without platelets (PLTs), plasma, and cryoprecipitate. Data on the transfusion, return to blood bank, and wastage rates were recorded on all products issued within 3 hours after MTP activation. RESULTS: The majority of products were issued to the emergency department and/or operating room at all three institutions (84%-95%). The percentage of RBCs, plasma, and PLTs transfused during MTPs were 39% to 65%, 43% to 66%, and 75% to 100%, respectively. Wastage rates were comparable for RBCs (0%-9%), plasma (0%-7%), and PLTs (0%-7%). Cryoprecipitate had the highest wastage rates at all three sites (7%-33%). CONCLUSION: A large portion of blood products issued during MTPs are not transfused. Some are wasted due to stringent storage requirements and/or limited shelf lives. The optimum ratio of transfused to returned products in these patients is likely to be determined more by clinical need than by transfusion service policy.

Contemporary outcomes of civilian lower extremity arterial trauma.

OBJECTIVE: Lower extremity arterial injury may result in limb loss after blunt or penetrating trauma. This study examined outcomes of civilian lower extremity arterial trauma and predictors of delayed amputation. METHODS: The records of patients presenting to a major level I trauma center from 2004 to 2014 with infrainguinal arterial injury were identified from a prospective institutional trauma registry, and outcomes were reviewed. Standard statistical methods were used for data analysis. RESULTS: We identified 149 patients (86% male; mean age, 33 ± 14 years,). Of these, 46% presented with blunt trauma: 19 (13%) had common femoral artery, 26 (17%) superficial femoral artery, 50 (33%) popliteal, and 54 (36%) tibial injury. Seven patients underwent primary amputation; of the remainder, 21 (15%) underwent ligation, 85 (59%) revascularization (80% bypass grafting, 20% primary repair), and the rest were observed. Delayed amputation was eventually required in 24 patients (17%): 20 (83%) were due to irreversible ischemia or extensive musculoskeletal damage, despite having adequate perfusion. Delayed amputation rates were 26% for popliteal, 20% for tibial, and 4.4% for common/superficial femoral artery injury. The delayed amputation group had significantly more (P < .05) blunt trauma (79% vs 30%), popliteal injury (46% vs 27%), compound fracture/dislocation (75% vs 33%), bypass graft (63% vs 43%), and fasciotomy (75% vs 43%), and a higher mangled extremity severity score (6.1 ± 1.8 vs 4.3 ± 1.6). Predictors of delayed amputation included younger age, higher injury severity score, popliteal or multiple tibial injury, blunt trauma, and pulseless examination on presentation. CONCLUSIONS: Individualized decision making based on age, mechanism, pulseless presentation, extent of musculoskeletal trauma, and location of injury should guide the intensity of revascularization strategies after extremity arterial trauma. Although patients presenting with vascular trauma in the setting of multiple negative prognostic factors should not be denied revascularization, expectations for limb salvage in the short-term and long-term periods should be carefully outlined.

Changes in blood product utilization in a seven-hospital system after the implementation of a patient blood management program: A 9-year follow-up.

OBJECTIVES: To analyze changes in red blood cell (RBC), platelet (PLT), and plasma transfusion volumes 9 years after the implementation of a multifaceted patient blood management (PBM) program across multiple hospitals. METHODS: Between fiscal years 2007 and 2015, the annual transfusion volumes for seven hospitals in a regional healthcare system were analyzed by hospital, and between 2014 and 2015, by four service lines including emergency department, intensive care unit (ICU), medical/surgical ward, and operating room at each hospital. The number of units of RBCs administered to transfused recipients on the wards and in ICUs was also enumerated. RESULTS: For these seven hospitals combined, there was a 29.9% reduction in the number of RBCs transfused between 2007 and 2015, a 24.8% reduction in plasma units, and a 25.7% reduction in PLT units. The two largest hospitals saw some of the largest reductions in RBC transfusions (40.1, 25.1%), and plasma transfusions (26.1, 33.8%), and one of those hospitals had a 49.5% reduction in PLT transfusions. Smaller-sized hospitals also had reductions in transfusion volumes, while some volumes increased at hospitals when new or expanded clinical services were introduced. The number of RBC units per transfused recipient was generally between 1.5 and 2 units on the wards and slightly higher in the ICUs. DISCUSSION: Although the overall volume of transfusions has generally decreased at each hospital site over time, the appropriateness of the administered transfusions cannot be evaluated by these data. CONCLUSION: The system-wide implementation of a PBM program has reduced transfusion volumes.

The effect of stationary versus rocked storage of whole blood on red blood cell damage and platelet function.

BACKGROUND: Increasingly, cold-stored whole blood (WB) is being considered for the resuscitation of civilian trauma patients. It is unclear whether the WB should be agitated to enhance the function of the platelets (PLTs) or whether agitation will cause RBC damage. STUDY DESIGN AND METHODS: WB units were collected by standard procedures using a PLT-sparing inline leukoreduction filter and stored between 1 and 6°C. On Storage Day 3 each unit was divided into 4 subunits that were stored under one of the following conditions for 21 days: unrocked, manually rocked once daily, continuously rocked end over end, or continuously rocked horizontally. From Day 3 to Day 10, hemolysis and the mechanical fragility index (MFI) for RBC injury were measured daily and again on Days 15 and 21 (n = 9-16 units tested each time). On Days 4 and 10, rapid thromboelastogram (rTEG) measurements were performed (n = 8-10 units tested each time). RESULTS: Hemolysis and MFI increased significantly between Day 3 and Day 21 (p < 0.0001) for all RBC rocking conditions, as well as the unrocked units. Only the manually and horizontally rocked units demonstrated higher hemolysis (on Day 21) and MFI (starting on Day 10) compared to the unrocked units. Only the α-angle and maximum amplitude in the end-over-end rocked units increased significantly between Day 4 and Day 10. There were no significant differences between the rocked and unrocked units on Day 10 for any rTEG variable. CONCLUSIONS: Rocking does not appear to enhance in vitro PLT activity in cold-stored WB and can lead to increased hemolysis.

Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT) Study.

Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated). We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating on parameters that have more direct policy implications, these potentially automated approaches allow methodological standardization across similar comparativeness effectiveness studies.

An abdominal computed tomography may be safe in selected hypotensive trauma patients with positive Focused Assessment with Sonography in Trauma examination.

BACKGROUND: Positive Focused Assessment with Sonography in Trauma examination and hypotension often indicate urgent surgery. An abdomen/pelvis computed tomography (apCT) may allow less invasive management but the delay may be associated with adverse outcomes. METHODS: Patients in the Prospective Observational Multicenter Major Trauma Transfusion study with hypotension and a positive Focused Assessment with Sonography in Trauma (HF+) examination who underwent a CT (apCT+) were compared with those who did not. RESULTS: Of the 92 HF+ identified, 32 (35%) underwent apCT during initial evaluation and apCT was associated with decreased odds of an emergency operation (odds ratio .11, 95% confidence interval .001 to .116) and increased odds of angiographic intervention (odds ratio 14.3, 95% confidence interval 1.5 to 135). There was no significant difference in 30-day mortality or need for dialysis. CONCLUSIONS: An apCT in HF+ patients is associated with reduced odds of emergency surgery, but not mortality. Select HF+ patients can safely undergo apCT to obtain clinically useful information.

Preinjury warfarin, but not antiplatelet medications, increases mortality in elderly traumatic brain injury patients.

BACKGROUND: Previous studies of traumatic brain injury (TBI) outcomes in elderly patients on oral antithrombotic (OAT) therapies have yielded conflicting results. Our objective was to examine the effect of premorbid OAT medications on outcomes among elderly TBI patients with intracranial hemorrhage. METHODS: We performed a retrospective analysis of elderly TBI patients (≥65 years) with closed head injury and evidence of brain hemorrhage on computed tomography scan from 2006 to 2010. Patient demographics, injury severity, clinical course, hospital and intensive care unit length of stay, and disposition were collected. Comparison of patients stratified by premorbid OAT use was performed using nonparametric Kruskal-Wallis and Fisher's exact tests. Multivariable logistic regression was used to compare groups and identify predictors of primary outcomes, including mortality, neurosurgical intervention, hemorrhage progression, complications, and infection. RESULTS: A total of 1,552 patients were identified: 543 on aspirin only, 97 on clopidogrel only, 218 on warfarin only, 193 on clopidogrel and aspirin, and 501 on no antithrombotic agent. Blood products were administered to reverse coagulopathy in 77.3% of patients on antithrombotic medications. After adjusting for covariates, including medication reversal, OAT use was associated with increased mortality (p = 0.04). Warfarin use was identified as a key predictor (odds ratio, 2.27; p = 0.05), in contrast to the preinjury use of antiplatelet medications, which was not associated with increased risk of in-hospital death. Rates of neurosurgical intervention differed between groups, with patients on warfarin undergoing intervention more frequently. Survivor subset analysis demonstrated that hemorrhage progression was not associated with preinjury antithrombotic therapy, nor were rates of complication or infection, hospital and intensive care unit lengths of stay, or ventilator days. CONCLUSION: Preinjury use of warfarin, but not antiplatelet medications, influences survival and need for neurosurgical intervention in elderly TBI patients with intracranial hemorrhage; hemorrhage progression and morbidity are not affected. The importance of antithrombotic therapy may lie in its impact on initial injury severity. LEVEL OF EVIDENCE: Epidemiologic study, level III.

Clinical gestalt and the prediction of massive transfusion after trauma.

INTRODUCTION: Early recognition and treatment of trauma patients requiring massive transfusion (MT) has been shown to reduce mortality. While many risk factors predicting MT have been demonstrated, there is no universally accepted method or algorithm to identify these patients. We hypothesised that even among experienced trauma surgeons, the clinical gestalt of identifying patients who will require MT is unreliable. METHODS: Transfusion and mortality outcomes after trauma were observed at 10 U.S. Level-1 trauma centres in patients who survived ≥ 30 min after admission and received ≥ 1 unit of RBC within 6h of arrival. Subjects who received ≥ 10 units within 24h of admission were classified as MT patients. Trauma surgeons were asked the clinical gestalt question "Is the patient likely to be massively transfused?" 10 min after the patients arrival. The performance of clinical gestalt to predict MT was assessed using chi-square tests and ROC analysis to compare gestalt to previously described scoring systems. RESULTS: Of the 1245 patients enrolled, 966 met inclusion criteria and 221 (23%) patients received MT. 415 (43%) were predicted to have a MT and 551(57%) were predicted to not have MT. Patients predicted to have MT were younger, more often sustained penetrating trauma, had higher ISS scores, higher heart rates, and lower systolic blood pressures (all p<0.05). Gestalt sensitivity was 65.6% and specificity was 63.8%. PPV and NPV were 34.9% and 86.2% respectively. CONCLUSION: Data from this large multicenter trial demonstrates that predicting the need for MT continues to be a challenge. Because of the increased mortality associated with delayed therapy, a more reliable algorithm is needed to identify and treat these severely injured patients earlier.