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Objectives: The objective of this study was to characterize the bleeding, transfusion, and other outcomes of patients related to the timing of prasugrel or clopidogrel withdrawal before coronary artery bypass grafting (CABG).Background: There is little evidence to guide clinical decision making regarding the use of prasugrel in patients who may need urgent or emergency CABG. Experience with performing CABG in the presence of clopidogrel has raised concern about perioperative bleeding complications that are unresolved.Methods: A subset of the TRITON-TIMI 38 study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38), in which patients with acute coronary syndrome were randomized to treatment with aspirin and either clopidogrel or prasugrel, underwent isolated CABG (N = 346). A supplemental case report form was designed and administered, and the data combined with the existing TRITON-TIMI 38 database. Baseline imbalances were corrected for using elements of the European System for Cardiac Operative Risk Evaluation and The Society of Thoracic Surgeons predictive algorithm.Results: A significantly higher mean 12-h chest tube blood loss (655 ± 580 ml vs. 503 ± 378 ml; p = 0.050) was observed with prasugrel compared with clopidogrel, without significant differences in red blood cell transfusion (2.1 U vs. 1.7 U; p = 0.442) or the total donor exposure (4.4 U vs. 3.0 U; p = 0.463). All-cause mortality was significantly reduced with prasugrel (2.31%) compared with 8.67% with clopidogrel (adjusted odds ratio: 0.26; p = 0.025).Conclusions: Despite an increase in observed bleeding, platelet transfusion, and surgical re-exploration for bleeding, prasugrel was associated with a lower rate of death after CABG compared with clopidogrel. [ABSTRACT FROM AUTHOR]

Objective: To rationalize decision-making concerning the growing and costly off-label use of recombinant human factor VII (rFVIla, NovoSeven(R) therapy. Options: Using rFVIla therapy for patients with bleeding or providing usual care (e.g., continued clotting factor replacement). Outcome: Morbidity and mortality related to continued bleeding or thrombosis. Evidence: A literature review was per- formed to assess the efficacy and safety of off- label rFVIIa therapy. An expert consensus panel reviewed the data. Most studies were case series or reports. Only four randomized trials were avail-able in the peer-reviewed literature at the time of the panel's deliberations. The Rand Corporation/University of California at Los Angeles Appropriateness Method was used to rate 41 clinical scenarios as 'appropriate,' 'uncertain,' or 'inappropriate' in a comparison of risks and benefits in an environment with constrained health care costs. Values: The panel comprised nine geographically diverse clinicians to represent the interests of clinical specialties, including anesthesiology/critical care, surgery, trans-fusion medicine/hematology, pharmacy, neurology/critical care, and practice environments. Benefits, Harms, and Costs: The panel's recommendations are expected to limit the use of rFVIIa to the most appropriate circumstances, thus minimizing associated risks and costs. These suggestions should be considered consistent with the quality and quantity of the available evidence and should be adjusted as new evidence emerges. Recommendations: The panel rated the use of rFVIIa as 'appropriate' in limited circumstances: (1) cardiac, thoracic aortic, or spinal surgery; hepatic resection; hysterectomy; or postpartum bleeding (when significant clotting factor replacement has failed); (2) for severe multiple trauma (only if surgery and substantial blood replacement are unsuccessful); and (3) for nontraumatic intracranial bleeding (only if less than four hours has elapsed since symptom onset or if traumatic bleeding is associated with anticoagulant use and hematoma expansion). Doses of 20 to 40 mcg/kg were recommended for non-emergent anticoagulant reversal. Doses of 41 to 90 mcg/kg were recommended for all other scenarios. [ABSTRACT FROM AUTHOR]

Phosphorus has an essential role in cellular and extracellular metabolism; maintenance of normal phosphorus homeostasis is critical. Phosphorus homeostasis can be affected by diet and certain medications; some intravenous iron formulations can induce renal phosphate excretion and hypophosphatemia, likely through increasing serum concentrations of intact fibroblast growth factor 23. Case studies provide insights into two types of hypophosphatemia: acute symptomatic and chronic hypophosphatemia, while considering the role of pre-existing conditions and comorbidities, medications, and intravenous iron. This review examines phosphorus homeostasis and hypophosphatemia, with emphasis on effects of iron deficiency and iron replacement using intravenous iron formulations., (© 2021 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.)

Introduction and Objective: Intravenous iron preparations rapidly correct iron deficiency anemia, with the notable drug class effect of rare, yet potentially life-threatening, administration-related hypersensitivity or anaphylactic reactions. The objective of this comparative study was to assess adverse events associated with four intravenous iron preparations and estimated medical costs, in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database., Methods: Cases of hypersensitivity reactions and anaphylaxis/anaphylactic shock associated with iron dextran, iron sucrose, ferumoxytol, and ferric carboxymaltose, spontaneously reported to FAERS (1 January, 2014 to 31 December, 2019), were extracted. The reporting odds ratio lower bound 90% confidence interval (ROR05) > 1 and cases ≥ 5 defined a likely signal for a drug-adverse event association. Adverse event-associated medical costs were estimated using Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project 2016 data., Results: For hypersensitivity reactions, ferumoxytol and iron dextran had the highest ROR05 values (5.00 and 4.35, respectively) and greatest proportions of associated deaths (7.1% and 5.3%), followed by iron sucrose (ROR05 3.94, deaths 2.4%), and ferric carboxymaltose (ROR05 3.03, deaths 0.2%). For anaphylaxis/anaphylactic shock, ROR05 for cases/deaths were: 39.32/13.4%, ferumoxytol; 37.80/4.5%, iron dextran; 17.60/4.7%, iron sucrose; and 8.77/no deaths, ferric carboxymaltose. Downstream medical costs per adverse event were highest with iron dextran (US$8615) and ferumoxytol (US$8164), followed by iron sucrose (US$4212), and ferric carboxymaltose (US$1832)., Conclusions: Reporting rates of hypersensitivity and anaphylaxis with intravenous iron preparations were highest with ferumoxytol and lowest with ferric carboxymaltose in the US FAERS database. Adverse event-related medical costs were highest for iron dextran and ferumoxytol, and lowest for ferric carboxymaltose.

Anemia is a common finding in the perioperative setting with significant untoward consequences including worsening of outcomes and diminished quality of life as well as increased risk of allogeneic blood transfusions. Here, we present 3 cases that illustrate how anemia can be perioperatively managed in patients undergoing cardiac, orthopedic, and oncology surgeries. Timely detection of anemia prior to high-blood loss surgeries can allow clinicians to manage it and optimize hemoglobin level, making patients better prepared for the surgery. Treatment of anemia should be guided by the etiology and may include erythropoietic agents, folic acid, B12, and iron preparations. Other blood management strategies geared toward reducing surgical blood loss such as autologous transfusion techniques and agents to optimize hemostasis are used during surgery and in the immediate postoperative period. Patients should be closely monitored following surgery for signs of ongoing bleeding in need of control. Finally, screening for and management of anemia should continue in the postoperative and postdischarge period, as persistence and recurrence of anemia can further undermine patient's outcomes., (© 2020 by The American Society of Hematology.)

Objectives: Increasingly complex medical care requires specialized transfusion support close at hand. Hospital growth can necessitate expansion of blood bank services to new locations to ensure rapid delivery of blood products. We describe the opening of a new satellite transfusion service designed to serve the needs of a pediatric hospital., Methods: Institutional transition teams and stakeholders collaborated to discuss options for providing blood at a new pediatric hospital. A staffed satellite transfusion service met the diverse needs of multiple services and was considered a compromise between a full new transfusion service and automated solutions., Results: Initial challenges in establishing the laboratory included regulatory uncertainty and interactions between two hospitals' information technology services. Laboratory scientist staffing and actual use required adapting the satellite service to an emergency release-only model., Conclusions: A flexibly staffed satellite transfusion service met the most urgent needs of a pediatric hospital expansion. Review of implementation revealed potential process improvements for future expansions, including comprehensive routine and massive transfusion simulations. The challenges experienced in supplying staff and specialized blood products track with national trends. Other institutions may consider establishing a satellite transfusion service in the context of both increasingly sophisticated automated solutions and complex blood needs., (© American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Patients with chronic kidney disease (CKD) are at increased risk for infection, attributable to immune dysfunction, increased exposure to infectious agents, loss of cutaneous barriers, comorbid conditions, and treatment-related factors (eg, hemodialysis and immunosuppressant therapy). Because iron plays a vital role in pathogen reproduction and host immunity, it is biologically plausible that intravenous iron therapy and/or iron deficiency influence infection risk in CKD. Available data from preclinical experiments, observational studies, and randomized controlled trials are summarized to explore the interplay between intravenous iron and infection risk among patients with CKD, particularly those receiving maintenance hemodialysis. The current evidence base, including data from a recent randomized controlled trial, suggests that proactive judicious use of intravenous iron (in a manner that minimizes the accumulation of non-transferrin-bound iron) beneficially replaces iron stores while avoiding a clinically relevant effect on infection risk. In the absence of an urgent clinical need, intravenous iron therapy should be avoided in patients with active infection. Although serum ferritin concentration and transferrin saturation can help guide clinical decision making about intravenous iron therapy, definition of an optimal iron status and its precise determination in individual patients remain clinically challenging in CKD and warrant additional study., (© 2020 The Authors.)