BACKGROUND.Convalescent plasma is the only antibody-based therapy currently available for patients with coronavirus disease 2019 . It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19.METHODS. Thus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent plasma. RESULTS.The incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first 4 hours after transfusion was <1%. Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n = 4), transfusion-associated circulatory overload (n = 7), transfusion-related acute lung injury (n = 11), and severe allergic transfusion reactions (n = 3). However, only 2 of 36 SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The 7-day mortality rate was 14.9%. CONCLUSION.Given the deadly nature of COVID-19 and the large population of critically ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19. TRIAL REGISTRATION. ClinicalTrials.gov NCT04338360.
Background: Convalescent plasma is the only antibody based therapy currently available for COVID-19 patients. It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19. Methods: Thus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5,000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA Expanded Access Program for COVID-19 convalescent plasma. Results: The incidence of all serious adverse events (SAEs) in the first four hours after transfusion was <1%, including mortality rate (0.3%). Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n=4), transfusion-associated circulatory overload (TACO; n=7), transfusion-related acute lung injury (TRALI; n=11), and severe allergic transfusion reactions (n=3).However, only 2 (of 36) SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The seven-day mortality rate was 14.9%. Conclusion:Given the deadly nature of COVID-19 and the large population of criticallyill patients included in these analyses, the mortality rate does not appear excessive.These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.
Recent combat experience reignited interest in transfusing whole blood (WB) for patients with lifethreatening bleeding. US Army data indicate that WB transfusion is associated with improved or comparable survival compared to resuscitation with blood components. These data complement randomized controlled trials that indicate that platelet (PLT)-containing blood products stored at 48C have superior hemostatic function, based on reduced bleeding and improved functional measures of hemostasis, compared to PLT-containing blood products at 228C.WB is rarely available in civilian hospitals and as a result is rarely transfused for patients with hemorrhagic shock. Recent developments suggest that impediments to WB availability can be overcome, specifically the misconceptions that WB must be ABO specific, that WB cannot be leukoreduced and maintain PLTs, and finally that cold storage causes loss of PLT function. Data indicate that the use of low anti-A and anti-B titer group O WB is safe as a universal donor, WB can be leukoreduced with PLT-sparing filters, and WB stored at 48C retains PLT function during 15 days of storage. The understanding that these perceived barriers are not insurmountable will improve the availability of WB and facilitate its use. In addition, there are logistic and economic advantages of WB-based resuscitation compared to component therapy for hemorrhagic shock. The use of low-titer group O WB stored for up to 15 days at 48C merits further study to compare its efficacy and safety with current resuscitation approaches for all patients with life-threatening bleeding. hemorrhagic shock and immediately life-threatening injuries. DCR has many components all of which are aimed at preventing or treating shock and coagulopathy and thereby reducing morbidity and mortality from severe traumatic injuries causing massive hemorrhage.1 Hemostatic resuscitation is the central tenet of DCR. This concept developed with the recognition that a blood-based transfusion strategy would be optimal for severe bleeding and that crystalloid or colloid-based resuscitation cause hemodilution, acidosis, and a steady decline in oxygen delivery, which aggravate the underlying coagulation and metabolic disorders that evolve after injury and blood loss.2 Although a natural and obvious hemostatic resuscitation product would be whole blood (WB), it is not commonly available in the developed world, so many substitute components transfused at high ratios of plasma and platelets (PLTs) to red blood cells (RBCs) that range between 1:1:2 and 1:1:1 units, respectively. Goal-directed hemostatic resuscitation is also being explored as a method to alter empiric ratios of blood products and provide specific therapies based on the rapid results from point-of-care coagulation and shock monitoring. Recognizing the lack of robust clinical trial data available to support the development of optimal resuscitative strategies in patients with traumatic hemorrhagic shock, the following will review the history of trauma resuscitation and the evidence r...
Very-low-quality evidence suggests that plasma infusion in the setting of massive transfusion for trauma patients may be associated with a reduction in the risk of death and multiorgan failure. A survival benefit was not demonstrated in most other transfusion populations.
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