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• W2774033477 abstract "Dr Stubbs and colleagues are to be commended for their tireless efforts to advance platelet transfusion therapy for bleeding patients, which they richly document in the current issue of TRANSFUSION.1 Some centers maintained dual platelet inventories until the early 1980s—one stored at room temperature for prophylactic transfusions and the other stored refrigerated for bleeding patients. Since the abandonment of this practice, we have applied a “one-size-fits-all” approach to platelet transfusion, although the primary intended function for a platelet transfusion is substantially different based on its indication. Patients with acute hemorrhage as a result of gross vascular disruption require maximal hemostatic function provided by platelets. In contrast, the primary function of platelets in the prevention of bleeding is to remain in the circulation and repair the subtle damage to endothelium that may occur in the setting of thrombocytopenia. Murphy, Gardner, Becker, Aster, Valeri, and Slichter, to name just a few of the great pioneers of platelet transfusion, toiled over the challenges of storing these cells, trying to achieve an elusive balance between hemostatic function that can respond to hemorrhage and the need for prolonged circulation in the setting of prophylactic transfusion. Unfortunately, to date, this balance has been impossible to achieve. Room temperature storage results in loss of platelet hemostatic function with preservation of circulation time, whereas cold storage leads to desialation and early clearance (over 1-2 days) but preservation of hemostatic function for an extended period of storage time.2, 3 In an era of precision medicine, which in fact echoes the organizing principle of transfusion medicine (right product, right patient, right time), we must now reconsider our approach to platelet transfusion and do our best to optimize products to meet patient needs. This change in approach would entail adoption of dual or, perhaps in the future, multiple platelet inventories, a suggestion that often worries the transfusion community but should not.4 Dr Stubbs and his colleagues are leading the way by delivering a platelet product with improved hemostatic function (right product) to bleeding patients (right patient) as soon as possible to control hemorrhage—in helicopters and in the emergency department (right time). The team at the Mayo Clinic is blazing the path to major public health gains. In the United States alone, there are approximately 30,000 potentially preventable deaths per year after traumatic injury due to severe bleeding. Trauma is the most common cause of death in patients ages 1 to 46 years and is the cause of the most life-years lost before age 75.5 Over one-half of the US population faces a greater than 1-hour delay before treatment in a Level 1 trauma center and thus lacks access to hemostatic resuscitation in the crucial minutes after injury, when platelets could mean the difference between life and death. Smaller hospitals generally do not stock platelets; and, even in larger centers, platelets are mostly used in hematology-oncology patients. By re-introducing cold-stored platelets, Stubbs and colleagues have explicitly addressed the acute needs of bleeding patients. Theirs was a first step toward making hemostatic resuscitation more broadly available to the patients at highest risk of imminent death. As noted by Stubbs and coworkers, “the Code of Federal Regulations (CFR) Title 21, Section 640.25(a) allows for the storage of platelet products intended for transfusion at room temperature (from 20°C to 24°C) with agitation and at refrigerated temperature (from 1°C to 6°C) without agitation.”1 The CFR is the law of the land; and, conveniently, it was written in the era when both approaches to platelet storage were in use. The major barrier to cold platelet implementation broken by the Mayo Clinic team was the extension of cold storage as an alternative method for whole blood–derived platelet concentrates to irradiated apheresis platelet units. It is astonishing that this process required 2 years of correspondence, because apheresis products are universally considered to be functionally interchangeable with pooled, whole blood–derived products. It is also unfortunate that the AABB was initially resistant to the implementation of this patient-centered transfusion solution. Nevertheless, the door is now open for others to continue to innovate. A recent precedent has been established with both the US Food and Drug Administration (FDA) and the AABB to begin using cold-stored platelets for bleeding patients. Why is the use of cold-stored platelets so important? A large body of in vitro data documents the loss of hemostatic function in room temperature–stored platelets.2 Despite their preserved ability to circulate for up to 1 week post-transfusion in healthy donors, room temperature–stored platelets lose aggregation response to most agonists after 3 days of storage. Furthermore, they do not adhere well to collagen under arterial flow conditions and produce weaker clots. Room temperature storage leads to platelet release of potent inflammatory mediators like soluble CD40 ligand (sCD40L) and, of course, increases the risk of bacterial contamination of the product.6 Cold storage, on the other hand, preserves aggregation function and adhesion under arterial shear forces, leads to the formation of strong clots, and diminishes the risk of inflammatory reactions and infection. Cold-stored platelets can also be inhibited by nitric oxide, prostacyclin, and other direct platelet inhibitors.7 Therefore, the historical concern that cold platelets are “irreversibly activated” and increase the risk of disseminated intravascular coagulation is not supported by recent experiments or clinical trial data. In vivo data from intravital microscopy animal models show us directly that cold-stored platelets contribute to clot formation and produce strong clots.8 Clinical data from multiple studies demonstrate that cold-stored platelets work better to treat acute bleeding than room temperature–stored platelets.2 Even the pivotal study by Murphy and Gardner establishing the paradigm of room temperature storage demonstrated that cold-stored platelets would circulate for at least 1 day—more than enough time to participate in primary hemostasis and clot formation in the bleeding patient.9 The often-repeated statement that cold-stored platelets are not functional and are cleared too quickly to be useful should finally be expunged from transfusion medicine textbooks. Cold platelets are hemostatically active and should be the product of choice for bleeding patients in whom the loss of circulating time is clearly not worth the loss of hemostatic function. Stubbs and colleagues have identified several barriers to fielding cold-stored platelets in addition to the inherent, although manageable, complexities of dual inventory management. Inventory complexity is an unavoidable cost of patient-centered precision medicine; however, fortunately, we in transfusion medicine can adapt the lessons learned by such diverse industries as shoe and garment manufacturing, pharmacies, food distribution, and others to deliver the right product to the right patient at the right time. The CFR section on platelet storage was written in an era of 72-hour storage, based on the limited storage capacity of plastic bags at that time As described in their report, the Mayo Clinic team was held to 72-hour storage by the FDA. This limitation led to an effective shelf-life of 2 days because of the turn-around time of infectious disease testing and a very high out-date rate. Because the FDA uses a surrogate marker for efficacy to approve platelet products for prophylactic transfusion (namely, post-transfusion recovery and survival), it would stand to reason that a surrogate marker adapted to the care of bleeding patients would be adopted to guide shelf-life determination by regulators. Indeed, Stubbs and coworkers suggested the thromboelastometry maximum amplitude parameter as a reasonable surrogate efficacy marker and demonstrated cold-platelet function to at least 5 days of storage.1 However, as in clinical practice, we have had a one-size-fits-all approach to regulating platelets, and the current FDA ruling limiting cold storage to 3 days still stands. For obvious reasons, this should change. The major gains in public health through increased access to safe platelet transfusion will only be realized when shelf-life increases into the time frame from 10 to 21 days. Recent studies have demonstrated that cold storage of apheresis platelets in platelet additive solution (PAS) reduces in-bag activation and preserves hemostatic function for as long as 21 days.10 Storage in PAS also virtually eliminates the in-bag clotting problem observed by Stubbs and colleagues caused by the reduced fibrinogen concentration present during storage. Thus, cold storage in PAS offers the opportunity to dramatically expand platelet access and reduce product waste through reduced out-date; rejection due to bacterial contamination; and, finally, in-bag clotting. The regulatory path to licensing cold-stored platelets in PAS should minimize barriers to providing this product to the majority of Americans and indeed citizens of all countries who do not have access to hemostatic platelets for bleeding resuscitation. If platelet products destined primarily for prophylactic transfusion can be approved on the basis of in vitro studies and radiolabeled recovery and survival studies in healthy volunteers, then, logically, similar surrogate markers, such as thromboelastometry maximum amplitude or rotational thromboelastometry maximal clot firmness, or aggregation studies should be adequate to extend the shelf-life of a product already recognized in the CFR and already known to be safe through decades of clinical experience. The US Department of Defense (DoD) began transfusing cold-stored platelets in the CENTCOM area of operations (encompassing Iraq and Afghanistan as well as other countries in the region) in January 2016. Because of extraordinary logistical constraints that limited the distribution of cold platelets with a 3-day shelf-life (or, for that matter, room temperature platelets with a 5-day shelf-life), storage in this combat theater has been extended to 10 days at 1°C to 6°C without agitation (for both apheresis platelets stored in plasma and in PAS). Blood bank personnel reported visible clot formation in only a few of the first units collected; most product wastage has been caused by expiration. To date, 34 patients have received transfusion of one to four units, ranging in storage time from 1 to 9 days, in the context of damage-control resuscitation and massive transfusion. Anecdotal reports from attending physicians indicate expected hemostatic platelet function and no acute adverse transfusion reactions (personal communications with DoD CENTCOM staff). In short, although additional clinical experience beyond the limited reports by the Mayo Clinic team and the DoD would be expected to provide further details of hemostatic performance and safety, it appears that cold-stored platelet use is generally meeting functional expectations and is beginning to expand product access. The Trauma Hemostasis and Research (THOR) Network and the Pediatric Critical Care Blood Research Network (BloodNET) are developing and performing clinical trials to re-examine the efficacy and safety of cold-stored platelets compared with room temperature–stored platelets in bleeding populations (see the THOR Remote Damage Control Resuscitation Symposium web site at RDCR.org). Data from a single-center cardiac surgery study of 41 patients in Bergen, Norway, indicates reduced blood loss and improved platelet function by aggregometry when cold versus room temperature platelets are transfused.11 There is also a US trial in development that plans to compare cold-stored versus room temperature–stored platelets in both children and adults requiring cardiac surgery; in that trial, the clinical bleeding score will be the primary outcome. It is important to conduct these trials to examine the in vivo efficacy of cold-stored platelets that are stored for up to 21 days and to convince skeptics that the benefits suggested by in vitro data are confirmed in patients, justifying the operational availability of cold-stored platelets. The previous trials of cold-stored platelets did not examine this storage duration. Although the in vitro data are highly supportive of extending the shelf-life of cold stored-platelets, the generation of clinical data will support further implementation. The incidence of preventable deaths from traumatic hemorrhage each year in the United States is very high. Alternative methods are needed to address the shock and coagulopathy that occurs in this population and in all other patients with hemorrhagic shock. Patients who are exsanguinating from obstetric hemorrhage, gastrointestinal bleeding, and operative bleeding, for example, also need improved therapies that will improve their outcomes. The storage of platelets under refrigeration is a very simple and inexpensive solution to a very large problem. This evolution will require a new approach to licensing platelet products from the FDA and some adjustments to inventory management by blood banks. Clinical trial data are being generated that will allow for refinement of storage duration through 14 to 21 days, which is strongly supported by in vitro data. We all need to just chill—because it's worth it. The authors have no conflicts of interest relevant to the article submitted to TRANSFUSION. The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. Andrew P. Cap, MD, PhD, FACP Coagulation and Blood Research Program US Army Institute of Surgical Research FT Sam Houston, TX Department of Medicine Uniformed Services University Bethesda, MD e-mail: [email protected] Philip C. Spinella, MD, FCCM Director, Pediatric Critical Care Translational Research Program Professor, Department of Pediatrics Washington University in St Louis School of Medicine St Louis, MO" @default.
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• W2774033477 title "Just chill-it's worth it!" @default.
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