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Introduction: Delays in promptly recognizing and appropriately managing hemorrhagic injuries contribute to preventable trauma related deaths nationwide. We sought to identify patient variables available at the time of emergency department arrival associated with meeting the critical administration threshold., Methodology: We conducted a trauma registry review from September 2016 to March 2020 of trauma team activations at The Ottawa Hospital, a Level 1 Trauma Center. Our primary outcome was the frequency of meeting the critical administration threshold. Secondary outcomes included time to critical administration threshold, 24-h all-cause mortality, and 30-day all-cause mortality. Multivariate logistic regression identified factors independently associated with meeting the critical administration threshold., Results: We assessed 762 patients, of which 78 (10.2%) met the critical administration threshold. The median time to critical administration threshold was 28.9 min. Mortality at 24 h occurred in 58 (7.6%) patients. Four variables available upon patient arrival predicted the critical administration threshold, including systolic blood pressure ≤ 90 mmHg (OR 6.6; 95% CI 3.7-12.0), Glasgow Coma Scale ≤ 8 (OR 5.9; 95% CI 3.2-10.6), heart rate ≥ 100 beats/minute (OR 4.4; 95% CI 2.4-8.1), and respiratory rate ≥ 20 breaths/min (OR 2.2; 95% CI 1.2-4.0)., Conclusion: We identified four clinical variables readily available to physicians upon patient arrival associated with meeting the critical administration threshold: systolic blood pressure ≤ 90 mmHg, Glasgow Coma Scale ≤ 8, heart rate ≥ 100 beats/minute, and respiratory rate ≥ 20 breaths/min. Patients presenting with any of these clinical parameters should prompt physicians to consider ordering blood products immediately., Competing Interests: Declarations Conflict of interest The authors declare that they have no financial disclosures or conflicts of interest., (© 2024. The Author(s), under exclusive licence to the Canadian Association of Emergency Physicians (CAEP)/ Association Canadienne de Médecine d'Urgence (ACMU).)

Background: Trauma hemorrhage remains the most common cause of preventable mortality in trauma. To guide clinical practice, RCTs provide high-quality evidence to inform clinical decision making. The clinical relevance and inferences made by RCTs are dependent on assumptions made during sample size calculation., Methods: To describe the quality of methodology for sample size determination, we conducted a systemic review RCTs evaluating interventions that aim to improve survival in adults with trauma-related hemorrhage. Estimated and actual outcome data are compared, including components of sample size determination., Results: A total of 13 RCTs were included. We noted a high rate of negative trial results (11 of 13 studies). Most studies were multi-center and conducted in North America, evaluating patients with blunt and penetrating injuries. The criteria for hemorrhagic shock varied across studies. All studies did not accurately estimate the mortality rate during sample size calculation. All but one study overestimated the mortality reduction during sample size calculation; the median absolute mortality reduction was 3%, compared with a target of 10%. Only the CRASH-2 study used a minimal clinically important different for treatment effect target. No RCTs employed prognostic enrichment. Most studies were terminated (8 of 13), mainly for futility., Conclusion: Taken together, this review highlights that current clinical trial methodology is limited by imprecise control group risk estimates, overly optimistic treatment effect estimates, and lack of transparent justification for such targets. These limitations result in studies at high risk for futility and potentially premature abandonment of promising therapies. Given the high morbidity and mortality of trauma-related hemorrhage, we recommend that future conduct of trauma RCTs incorporate (1) prognostic enrichment to inform baseline risk, (2) justify target treatment differences based on clinical importance and realistic estimates of feasibility, and (3) be transparent and provide justification for the assumptions made., Level of Evidence: Systematic Review/Meta-Analysis; Level III., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Failure to rapidly identify bleeding in trauma patients leads to substantial morbidity and mortality. We aimed to develop and validate a simple bedside score for identifying bleeding patients requiring escalation of care beyond initial resuscitation., Methods: We included patients with major blunt or penetrating trauma, defined as those with an Injury Severity Score greater than 12 or requiring trauma team activation, at The Ottawa Hospital from September 2014 to September 2017. We used logistic regression for derivation. The primary outcome was a composite of the need for massive transfusion, embolization or surgery for hemostasis. We prespecified clinical, laboratory and imaging predictors using findings from our prior systematic review and survey of Canadian traumatologists. We used an AIC-based stepdown procedure based on the Akaike information criterion and regression coefficients to create a 5-variable score for bedside application. We used bootstrap internal validation to assess optimism-corrected performance., Results: We included 890 patients, of whom 133 required a major intervention. The main model comprised systolic blood pressure, clinical examination findings suggestive of hemorrhage, lactate level, focused assessment with sonography in trauma (FAST) and computed tomographic imaging. The C statistic was 0.95, optimism-corrected to 0.94. A simplified Canadian Bleeding (CAN-BLEED) score was devised. A score cut-off of 2 points yielded sensitivity of 97.7% (95% confidence interval [CI] 93.6 to 99.5) and specificity 73.2% (95% CI 69.9 to 76.3). An alternative version that included mechanism of injury rather than CT had lower discriminative ability (C statistic = 0.89)., Conclusion: A simple yet promising bleeding score is proposed to identify highrisk patients in need of major intervention for traumatic bleeding and determine the appropriateness of early transfer to specialized trauma centres. Further research is needed to evaluate the performance of the score in other settings, define interrater reliability and evaluate the potential for reduction of time to intervention.

Background: Due to the challenge of identifying need for intervention in bleeding patients, there is a growing interest in prediction modeling. Massive transfusion (MT; 10 or more packed red cells in 24 h) is the most commonly studied dependent variable, serving as a surrogate for severe bleeding and its prediction guides the need for intervention. The critical administration threshold (CAT; 3 packed red cells in 1 h) has been proposed as an alternative. In this study, we aim to compare the classification accuracy of these two surrogates for hemorrhage-related outcomes in health administrative datasets., Methods: We performed a secondary analysis of major trauma patients from the prospectively collected Ottawa Trauma Registry, from September 2014 to September 2017. We conducted a logistic regression analysis utilizing need for hemostasis or hemorrhagic death as dependent variables. We compared classification accuracy in terms of sensitivity, specificity, positive predictive value, negative predictive value and AUC. CAT + and MT + status is not mutually exclusive., Results: We studied 890 major trauma patients, including 145 CAT + and 48 MT + patients. CAT + demonstrated a superior association for the composite outcome of 24-hour hemorrhage-related mortality and need for hemostasis (AUC 0.815 vs. 0.644, p < 0.0001). This performance was driven by a substantial difference in sensitivity, noted to be 70.0% (95% CI 62.1-77.9%) for CAT + but only 30.0% (95% CI 22.1-37.9%) for MT+. CAT + and MT + demonstrated specificities of 92.9% (95% CI 91.1-94.7%) and 98.9% (98.1-99.6%) respectively., Conclusion: This study illustrates the concepts of survivorship and competing risk bias for massive transfusion. Utilizing a composite outcome of need for hemostasis and early hemorrhagic death, we demonstrate that CAT + is more accurate for identifying significantly bleeding patients., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Hemorrhage is a major cause of early mortality following a traumatic injury. The progression and consequences of significant blood loss occur quickly as death from hemorrhagic shock or exsanguination often occurs within the first few hours. The mainstay of treatment therefore involves early identification of patients at risk for hemorrhagic shock in order to provide blood products and control of the bleeding source if necessary. The intended scope of this review is to identify and assess combinations of predictors informing therapeutic decision-making for clinicians during the initial trauma assessment. The primary objective of this systematic review is to identify and critically assess any existing multivariable models predicting significant traumatic hemorrhage that requires intervention, defined as a composite outcome comprising massive transfusion, surgery for hemostasis, or angiography with embolization for the purpose of external validation or updating in other study populations. If no suitable existing multivariable models are identified, the secondary objective is to identify candidate predictors to inform the development of a new prediction rule., Methods: We will search the EMBASE and MEDLINE databases for all randomized controlled trials and prospective and retrospective cohort studies developing or validating predictors of intervention for traumatic hemorrhage in adult patients 16 years of age or older. Eligible predictors must be available to the clinician during the first hour of trauma resuscitation and may be clinical, lab-based, or imaging-based. Outcomes of interest include the need for surgical intervention, angiographic embolization, or massive transfusion within the first 24 h. Data extraction will be performed independently by two reviewers. Items for extraction will be based on the CHARMS checklist. We will evaluate any existing models for relevance, quality, and the potential for external validation and updating in other populations. Relevance will be described in terms of appropriateness of outcomes and predictors. Quality criteria will include variable selection strategies, adequacy of sample size, handling of missing data, validation techniques, and measures of model performance., Discussion: This systematic review will describe the availability of multivariable prediction models and summarize evidence regarding predictors that can be used to identify the need for intervention in patients with traumatic hemorrhage., Systematic Review Registration: PROSPERO CRD42017054589.