IMPORTANCE Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials. OBJECTIVE To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. DESIGN, SETTING, AND PARTICIPANTS Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013. INTERVENTIONS Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled). MAIN OUTCOMES AND MEASURES Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status. RESULTS No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, −4.2% [95% CI, −9.6% to 1.1%]; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, −3.7% [95% CI, −10.2% to 2.7%]; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, −5.4% [95% CI, −10.4% to −0.5%]; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications. CONCLUSIONS AND RELEVANCE Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01545232
Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SARS-CoV-2 infection. This international, multicentre, prospective cohort study included patients undergoing elective or emergency surgery during October 2020. Surgical patients with pre-operative SARS-CoV-2 infection were compared with those without previous SARS-CoV-2 infection. The primary outcome measure was 30-day postoperative mortality. Logistic regression models were used to calculate adjusted 30-day mortality rates stratified by time from diagnosis of SARS-CoV-2 infection to surgery. Among 140,231 patients (116 countries), 3127 patients (2.2%) had a pre-operative SARS-CoV-2 diagnosis. Adjusted 30-day mortality in patients without SARS-CoV-2 infection was 1.5% (95%CI 1.4-1.5). In patients with a pre-operative SARS-CoV-2 diagnosis, mortality was increased in patients having surgery within 0-2 weeks, 3-4 weeks and 5-6 weeks of the diagnosis (odds ratio (95%CI) 4.1 (3.3-4.8), 3.9 (2.6-5.1) and 3.6 (2.0-5.2), respectively). Surgery performed ≥ 7 weeks after SARS-CoV-2 diagnosis was associated with a similar mortality risk to baseline (odds ratio (95%CI) 1.5 (0.9-2.1)). After a ≥ 7 week delay in undertaking surgery following SARS-CoV-2 infection, patients with ongoing symptoms had a higher mortality than patients whose symptoms had resolved or who had been asymptomatic (6.0% (95%CI 3.2-8.7) vs. 2.4% (95%CI 1.4-3.4) vs. 1.3% (95%CI 0.6-2.0), respectively). Where possible, surgery should be delayed for at least 7 weeks following SARS-CoV-2 infection. Patients with ongoing symptoms ≥ 7 weeks from diagnosis may benefit from further delay.
BACKGROUND:Outcomes following pancreatic trauma have not improved significantly over the past two decades. A 2013 Western Trauma Association algorithm highlighted emerging data that might improve the diagnosis and management of high-grade pancreatic injuries (HGPIs; grades III-V). We hypothesized that the use of magnetic resonance cholangiopancreatography, pancreatic duct stenting, operative drainage versus resection, and nonoperative management of HGPIs increased over time. METHODS:Multicenter retrospective review of diagnosis, management, and outcomes of adult pancreatic injuries from 2010 to 2018 was performed. Data were analyzed by grade and time period (PRE, 2010(PRE, -2013 POST, 2014 POST, -2018 using various statistical tests where appropriate. RESULTS:Thirty-two centers reported data on 515 HGPI patients. A total of 270 (53%) had penetrating trauma, and 58% went directly to the operating room without imaging. Eighty-nine (17%) died within 24 hours. Management and outcomes of 426 24-hour survivors were evaluated. Agreement between computed tomography and operating room grading was 38%. Magnetic resonance cholangiopancreatography use doubled in grade IV/V injuries over time but was still low.Overall HGPI treatment and outcomes did not change over time. Resection was performed in 78% of grade III injuries and remained stable over time, while resection of grade IV/V injuries trended downward (56% to 39%, p = 0.11). Pancreas-related complications (PRCs) occurred more frequently in grade IV/V injuries managed with drainage versus resection (61% vs. 32%, p = 0.0051), but there was no difference in PRCs for grade III injuries between resection and drainage.Pancreatectomy closure had no impact on PRCs. Pancreatic duct stenting increased over time in grade IV/V injuries, with 76% used to treat PRCs. CONCLUSION:Intraoperative and computed tomography grading are different in the majority of HGPI cases. Resection is still used for most patients with grade III injuries; however, drainage may be a noninferior alternative. Drainage trended upward for grade IV/V injuries, but the higher rate of PRCs calls for caution in this practice.
Introduction: Historically, hemorrhage has been attributed as the leading cause (40%) of early death. However, a rigorous, real-time classification of the cause of death (COD) has not been performed. This study sought to prospectively adjudicate and classify COD to determine the epidemiology of trauma mortality. Methods: 18 trauma centers prospectively enrolled all adult trauma patients at the time of death during 12/2015-8/2017. Immediately following death, attending providers adjudicated the primary and contributing secondary COD using standardized definitions. Data were confirmed by autopsies, if performed. Results: 1536 patients were enrolled with a median age of 55 (IQR 32-75). 74.5% were male. Penetrating mechanism (n=412) patients were younger (32 vs 64, p<0.0001) and more likely male (86.7% vs. 69.9%, p<0.0001). Falls were the most common mechanism of injury (26.6%), with GSWs second (24.3%). The most common overall primary COD was TBI (45%), followed by exsanguination (23%). TBI was non-survivable in 82.2% of cases. Blunt patients were more likely to have TBI (47.8% vs. 37.4%, p<0.0001) and penetrating patients exsanguination (51.7% vs 12.5%, p<0.0001) as the primary COD. Exsanguination was the predominant prehospital (44.7%) and early COD (39.1%) with TBI most common later. Penetrating mechanism patients died earlier with 80.1% on day 0 (vs. 38.5%, p<0.0001). Most deaths were deemed disease related (69.3%), rather than by limitation of further aggressive care (30.7%). Hemorrhage was a contributing cause to 38.8% of deaths that occurred due to withdrawal of care. Conclusions: Exsanguination remains the predominant early primary COD with TBI accounting for most deaths at later time points. Timing and primary COD vary significantly by mechanism. Contemporaneous adjudication of COD is essential to elucidate the true understanding of patient outcome, center performance, and future research.
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