Novel agents are coming to the market and may address unmet needs in treating bleeding patients. Evidence based criteria for their use would assist hospitals and transfusion services in determining the appropriate indications for these products. This session will review evolving evidence from well-designed clinical trials to establish unbiased assessments of efficacy, adverse events and cost. For each product, the benefits and risks will be presented, and the novel products will be compared and contrasted to traditional therapies. First, controlled trials of fibrinogen concentrate in cardiac surgery will be reviewed. Next, the emerging use of andexanet alpha will be explored, including the clinical trials that resulted in FDA approval. Guidelines for justified clinical use and alternative treatments will be presented. Dosing strategies, including the incorporation of laboratory measurements of calibrated anti-Xa levels to guide therapy, will be discussed. Finally, the potential applications and characteristics of freeze dried plasma (and other similar products in development) will be presented, including their use in the military and their potential in the civilian setting.
Examine the evidence to support the use of fibrinogen concentrate during cardiac surgery.
Differentiate between the appropriate use and abuse of Xa inhibitor reversal agents.
Evaluate the logistical and clinical rationale for the use for freeze dried plasma versus conventional plasma components.
Medical Director and Vice President, Quality and Regulatory Affairs, Co-Director, Transfusion Medicine, Associate Clinical Professor, Laboratory Medicine and Pediatrics, Innovative Blood Resources,
Innovative Blood Resources
Co-Editor-in-Chief, "Transfusion and Apheresis Science” Journal, John H. Childers, MD, Professorship in Pathology, Professor (Tenure) of Pathology and Internal Medicine (Hematology/Oncology), Chief of Pathology and Medical Director, UTSW Clinical Laborato,
UT Southwestern Medical Center, Department of Pathology, Division of Transfusion Medicine and Hemostasis
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