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A comparison of resuscitation intensity (RI) and critical administration threshold (CAT) in predicting early mortality among bleeding patients: a multicenter validation in 680 major transfusion patients
Meyer DE, Cotton BA, Fox EE, Stein D, Holcomb JB, Cohen M, Inaba K, Rahbar E
The Journal of Trauma and Acute Care Surgery. 2018;85((4):):691-696
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Abstract
BACKGROUND To address deficiencies associated with the classic definition of massive transfusion, Critical Administration Threshold and Resuscitation Intensity were developed to better quantify the overall severity of illness and predict the need for transfusions and early mortality. We sought to evaluate these as more appropriate replacements for MT in defining mortality risk in patients undergoing major transfusions. METHODS Patients predicted to receive MT at 12 Level-1 trauma centers were randomized in the PROPPR trial. MT: ≥10U RBC in 24 hours; CAT+: ≥3U RBC in the first hour; and RI: total products in the first 30 minutes (1U RBC, 1U plasma, 1000mL crystalloid, 500mL colloid each valued at 1U). RI was evaluated as a continuous variable and dichotomized as RI4+, where RI≥4 U. Each metric was evaluated for its ability to predict mortality at 3, 6, and 24 hours, and at 30 days. RESULTS Of the 680 patients, 301 patients met MT definition, 521 were CAT+, and 445 were RI4+. Of those that died, 23% never reached MT threshold, but all were captured by CAT+ and RI4+. The 3-hr (9 vs. 9%), 6-hr (14 vs. 14%), 24-hr (17 vs. 18%), and 30-day mortality rates (28 vs. 29%) were similar between CAT+ and RI4+ patients. When RI was evaluated as a continuous variable, each unit increase was associated with a 20% increase in hemorrhage-related mortality (OR 1.20, 95% CI [1.15-1.29], p<0.05).CONCLUSIONBoth RI and CAT are valid surrogates for early mortality in patients undergoing major transfusion, capturing patients omitted by the MT definition. CAT+ showed the best sensitivity; RI4+ demonstrated better specificity and good PPV and NPV. While CAT+ may be suited for patients receiving a RBC-dominant resuscitation, RI4+ is more comprehensive. RI can also be used as a continuous variable to provide quantitative as well qualitative risk of death.LEVEL OF EVIDENCELevel III, Prognostic.
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The impact of hypothermia on outcomes in massively transfused patients
Lester ELW, Fox EE, Holcomb JB, Brasel KJ, Bulger EM, Cohen MJ, Cotton BA, Fabian TC, Kerby JD, O'Keefe T, et al
The Journal of Trauma and Acute Care Surgery. 2018
Abstract
BACKGROUND Hypothermia is associated with poor outcomes after injury. The relationship between hypothermia during contemporary large volume resuscitation and blood product consumption is unknown. We evaluated this association, and the predictive value of hypothermia on mortality. METHODS Patients predicted to receive massive transfusion at 12 Level-1 trauma centers, randomized in the PROPPR trial, were grouped into those who were hypothermic (<36 degrees Celsius) or normothermic (36-38.5 degrees Celsius) within the first 6 hours of Emergency department arrival. The impact of hypothermia or normothermia on the volume of blood product required during the first 24 hours was determined via negative binomial regression, adjusting for treatment arm, injury severity score, mechanism, demographics, pre-emergency department fluid volume, blood administered prior to becoming hypothermic, pulse and systolic blood pressure on arrival and the time exposed to hypothermic or normothermic temperatures. RESULTS Of 680 patients, 590 had a temperature measured during the first 6 hours in hospital, and 399 experienced hypothermia. The mean number of red blood cell units given to all patients in the first 24 hours of admission was 8.8 (95% CI 7.9-9.6). In multivariable analysis, every one-degree decrease in temperature below 36.0 degrees was associated with a 10% increase (incidence rate ratio [IRR] 0.90; 95% CI 0.89-0.92; p<0.00) in consumption of red blood cells during the first 24 hours of admission. There was no association between red blood cell administration and a temperature above 36 degrees. Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI 1.7-4.5; p<0.00) for 24-hour and 1.8 (95% CI 1.3-2.4; p<0.00) for 30-day mortality. CONCLUSION Hypothermia is associated with increased in blood product consumption and mortality. These findings support the maintenance of normothermia in trauma patients, and suggests that further investigation on the impact of cooling or rewarming during massive transfusion is warranted. LEVEL OF EVIDENCE III Prognostic.
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Risk factors for the development of acute respiratory distress syndrome following hemorrhage
Robinson BRH, Cohen MJ, Holcomb JB, Pritts TA, Gomaa D, Fox EE, Branson RD, Callcut RA, Cotton BA, Schreiber MA, et al
Shock (Augusta, Ga.). 2017;50((3):):258-264
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BACKGROUND The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) study evaluated the effects of plasma and platelets on hemostasis and mortality after hemorrhage. The pulmonary consequences of resuscitation strategies that mimic whole blood, remain unknown. METHODS A secondary analysis of the PROPPR study was performed. Injured patients predicted to receive a massive transfusion were randomized to 1:1:1 vs. 1:1:2 plasma-platelet-RBC ratios at 12 Level I North American trauma centers. Patients with survival >24 hours, an ICU stay, and a recorded PaO2/FiO2 (P/F) ratio were included. ARDS was defined as a P/F ratio < 200, with bilateral pulmonary infiltrates, and adjudicated by investigators. RESULTS 454 patients were reviewed (230 received 1:1:1, 224 1:1:2). Age, sex, injury mechanism, and regional abbreviated injury scale (AIS) scores did not differ between cohorts. Tidal volume, PEEP, and lowest P/F ratio did not differ. No significant differences in ARDS rates (14.8 vs. 18.4%), ventilator-free (24 vs. 24) or ICU-free days (17.5 vs. 18), hospital length of stay (22 vs. 18 days), or 30-day mortality were found (28 vs. 28%). ARDS was associated with blunt injury (OR 3.61 [1.53-8.81] p < 0.01) and increasing chest AIS (OR 1.40 [1.15-1.71] p < 0.01). Each 500 mL of crystalloid infused during hours 0-6 was associated with a 9% increase in the rate of ARDS (OR 1.09 [1.04-1.14] p < 0.01). Blood given at 0-6 or 7-24 hours were not risk factors for lung injury. CONCLUSION Acute crystalloid exposure, but not blood products, is a potentially modifiable risk factor for the prevention of ARDS following hemorrhage.
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Damage control resuscitation in patients with severe traumatic hemorrhage: a practice management guideline from the Eastern Association for the Surgery of Trauma
Cannon JW, Khan MA, Raja AS, Cohen MJ, Como JJ, Cotton BA, Dubose JJ, Fox EE, Inaba K, Rodriguez CJ, et al
The Journal of Trauma and Acute Care Surgery. 2017;82((3)):605-617.
Abstract
BACKGROUND The resuscitation of severely injured bleeding patients has evolved into a multi-modal strategy termed damage control resuscitation (DCR). This guideline evaluates several aspects of DCR including the role of massive transfusion (MT) protocols, the optimal target ratio of plasma (PLAS) and platelets (PLT) to red blood cells (RBC) during DCR, and the role of recombinant activated factor VII (rVIIa) and tranexamic acid (TXA). METHODS Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, a subcommittee of the Practice Management Guidelines (PMG) Section of EAST conducted a systematic review using MEDLINE and EMBASE. Articles in English from1985 through 2015 were considered in evaluating four PICO questions relevant to DCR. RESULT A total of 37 studies were identified for analysis, of which 31 met criteria for quantitative meta-analysis. In these studies, mortality decreased with use of an MT/DCR protocol vs. no protocol (OR 0.61, 95% CI 0.43-0.87, p = 0.006) and with a high ratio of PLASRBC and PLT:RBC (relatively more PLAS and PLT) vs. a low ratio (OR 0.60, 95% CI 0.46-0.77, p < 0.0001; OR 0.44, 95% CI 0.28-0.71, p = 0.0003). Mortality and blood product use were no different with either rVIIa vs. no rVIIa or with TXA vs. no TXA. CONCLUSION DCR can significantly improve outcomes in severely injured bleeding patients. After a review of the best available evidence, we recommend the use of a MT/DCR protocol in hospitals that manage such patients and recommend that the protocol target a high ratio of PLAS and PLT to RBC. This is best achieved by transfusing equal amounts of RBC, PLAS, and PLT during the early, empiric phase of resuscitation. We cannot recommend for or against the use of rVIIa based on the available evidence. Finally, we conditionally recommend the in-hospital use of TXA early in the management of severely injured bleeding patients.
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Every minute counts: time to delivery of initial massive transfusion cooler and its impact on mortality
Meyer DE, Vincent LA, Fox EE, O'Keeffe T, Inaba K, Bulger E, Holcomb JB, Cotton BA
The Journal of Trauma and Acute Care Surgery. 2017;83((1):):19-24
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BACKGROUND ACS-TQIP Best Practices recommends initial massive transfusion (MT) cooler delivery within 15 minutes of protocol activation, with a goal of 10 minutes. The current study sought to examine the impact of timing of first cooler delivery on patient outcomes. METHODS Patients predicted to receive MT at 12 level-1 trauma centers were randomized to two separate transfusion ratios as described in the PROPPR trial. ABC score or clinician gestalt prediction of MT was used to randomize patients and call for initial study cooler. In this planned sub-analysis, the time to MT protocol activation and time to delivery of the initial cooler were evaluated. The impact of these times on mortality and time to hemostasis were examined using both Wilcoxon rank sum and linear and logistic regression. RESULTS Among 680 patients, the median time from patient arrival to MT protocol activation was 9 minutes with a median time from MT activation call to delivery of first cooler of 8 minutes. An increase in both time to MT activation and time to arrival of first cooler were associated with prolonged time to achieving hemostasis (coef 1.09, p=0.001 and coef. 1.16, p < 0.001, respectively). Increased time to MT activation and time to arrival of first cooler were associated with increased mortality (OR 1.02, p=0.009 and OR 1.02, p = 0.012, respectively). Controlling for injury severity, physiology, resuscitation intensity, and treatment arm (1:1:1 vs. 1:1:2), increased time to arrival of first cooler was associated with an increased mortality at 24-hours (OR 1.05, p = 0.035) and 30-days (OR 1.05, p = 0.016). CONCLUSIONS Delays in MT protocol activation and delays in initial cooler arrival were associated with prolonged time to achieve hemostasis and an increase in mortality. Independent of products ratios, every minute from time of MT protocol activation to time of initial cooler arrival increases odds of mortality by 5%. LEVEL OF EVIDENCE Level II, Prognostic.
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Damage control resuscitation and emergency laparotomy: findings from the PROPPR Study
Undurraga Perl VJ, Leroux B, Cook MR, Watson J, FairK, Martin DT, Kerby JD, Williams C, Inaba K, Wade CE, et al
The Journal of Trauma and Acute Care Surgery. 2016;80((4):):568-74; discussion 574-5
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BACKGROUND The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial has demonstrated that damage control resuscitation, a massive transfusion strategy targeting a balanced delivery of plasma-platelet-RBC in a ratio of 1:1:1, results in improved survival at 3 hours and a reduction in deaths due to exsanguination in the first 24 hours compared to a 1:1:2 ratio. In light of these findings, we hypothesized that patients receiving 1:1:1 ratio would have improved survival after emergency laparotomy. METHODS Severely injured patients predicted to receive a massive transfusion admitted to 12 level I North American trauma centers were randomized to 1:1:1 versus 1:1:2 as described in the PROPPR trial. From these patients, the subset that underwent an emergency laparotomy, defined previously in the literature as laparotomy within 90 minutes of arrival, were identified. We compared rates and timing of emergency laparotomy as well as post-surgical survival at 24-hours and 30-days. RESULTS Of the 680 enrolled patients, 613 underwent a surgical procedure, 397 underwent a laparotomy, and 346 underwent an emergency laparotomy. The percentages of patients undergoing emergency laparotomy were 51.5% (174/338) and 50.3% (172/342) for 1:1:1 and 1:1:2, respectively (p=0.20). Median time to laparotomy was 28 minutes in both treatment groups. Among patients undergoing an emergency laparotomy, the proportions of patients surviving to 24 hours and 30 days were similar between treatment arms, 24-hour survival was 86.8% (151/174) for 1:1:1 and 83.1% (143/172) for 1:1:2 (p=0.29), and 30-day 79.3% (138/174) for 1:1:1 and 75.0% (129/172) for 1:1:2 (p=0.30). CONCLUSIONS We found no evidence that resuscitation strategy affects whether a patient requires an emergency laparotomy, time to laparotomy, or subsequent survival. LEVEL OF EVIDENCE Level IV, therapeutic study.