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New Strategies for the Optimal Use of Platelet Transfusions

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New Strategies for the Optimal Use of Platelet Transfusions TRANSFUSION MEDICINE ______________________________________________________________________ New Strategies for the Optimal Use of Platelet Transfusions Morris A. Blajchman,1 Sherrill J. Slichter,2 Nancy M. Heddle,3 and Michael F. Murphy4 1Departments of Medicine and Pathology, McMaster University, Canadian Blood Services, and the NHLBI Transfusion Medicine/Hemostasis Clinical Trials Network (TMH CTN); 2Puget Sound Blood Center, and University of Washington School of Medicine, Seattle, WA; and TMH CTN; 3Department of Medicine, McMaster University; 4National Health Service Blood & Transplant; Department of Haematology, Oxford Radcliffe Hospitals, and University of Oxford, UK. Patients with severe thrombocytopenia are presumed high-quality, prospective, randomized clinical trial to be at increased risk for bleeding, and consequently (RCT) data for evaluating the relative effects of it has been standard practice for the past four de- different platelet transfusion regimens or platelet cades to give allogeneic platelet transfusions to doses on clinical outcomes. Moreover, most of these severely thrombocytopenic patients as supportive RCTs have not used bleeding as the primary outcome care. Platelet transfusions may be given either measure. Two such studies on platelet dose have now prophylactically to reduce the risk of bleeding, in the been undertaken, the PLADO (Prophylactic PLAtelet absence of clinical hemorrhage (prophylactic transfu- DOse) and the SToP (Strategies for the Transfusion of sions), or to control active bleeding when present Platelets) trials. Data from these RCTs are not con- (therapeutic transfusions). While no one would argue tained in this overview, as these data have not yet with the need for platelet transfusions in the face of been completely analyzed or submitted for peer severe bleeding, important questions remain about review publication. what constitutes clinically significant bleeding and In addition to the above, several recent observa- whether a strategy of prophylactic platelet transfu- tional studies have raised the possibility that there is sions is effective in reducing the risk of bleeding in not a clear association between the occurrence of a clinically stable patients. It is now uncommon for major clinical bleeding episode and the platelet count patients undergoing intensive chemotherapy or bone in thrombocytopenic patients. Such findings have led marrow transplantation to die of hemorrhage, but it is to the questioning of the efficacy of prophylactic open to debate as to what degree platelet transfusions platelet transfusions in all clinically stable patients, have been responsible for this change in outcome, and whether a policy of therapeutic transfusions used given the many other advances in other aspects of only when patients have clinical bleeding might be as supportive care. effective and safe for selected patients. At least two If a prophylactic strategy is followed, the optimal RCTs evaluating the relative value of prophylactic transfusion trigger or quantity of platelets to be versus therapeutic platelet transfusions have been transfused prophylactically per transfusion episode initiated in thrombocytopenic patients with hematologi- needs to be addressed in adequately powered clinical cal malignancies. One such study, known as the trials, but these remain highly controversial issues. TOPPS (Trial of Prophylactic Platelets Study) study, is This is because, until recently, there have been few currently underway in the U.K. Introduction quency and severity of adverse events. The following is- Allogeneic platelet transfusions play a major role in the sues constitute the major relevant concerns: management of thrombocytopenic patients. The ready avail- 1. What is the available evidence for the existence of an ability of platelet concentrates has made a major contribu- optimum prophylactic platelet dose to prevent tion to support the development of intensive treatment regi- thrombocytopenic bleeding? mens for the treatment of patients with hematological and 2. What evidence exists that indicates that prophylactic other malignancies. Although considerable advances have platelet transfusions are superior to therapeutic plate- been made in many aspects of platelet transfusions in the let transfusions for the prevention and/or control of last 30 years, several areas of controversy continue to exist thrombocytopenic bleeding? with regard to the optimal approach to the use of platelet transfusions to further reduce the risk of clinically signifi- Platelets for transfusion can be prepared by three different cant thrombocytopenic hemorrhage in patients with a methods: (a) the platelet-rich plasma (PRP) method; (b) the hypoproliferative bone marrow and to minimize the fre- buffy coat (BC) method; and (c) the apheresis method.1,2 198 American Society of Hematology The PRP method, which is used almost exclusively in the hypersplenism, and the use of certain types of medications, United States, and the BC method, which is used predomi- as well as the presence of other factors.11 A recent study in nantly in Western Europe and Canada, derive platelets from experimental animals demonstrated that the presence of units of whole blood collected from volunteer whole blood inflammation, particularly during periods of severe donors.2 Studies comparing PRP and BC platelets have thrombocytopenia, was an important factor for the occur- shown no difference in the in vitro quality of such platelet rence of life-threatening bleeding.12 These experimental concentrates when they are stored for up to 5 days; how- data suggest that platelet transfusions may be required for ever, few studies of direct in vivo head-to-head compari- both the prevention and treatment of bleeding in thromb- sons of these two methods of preparing platelet concen- ocytopenic patients, but that the optimal approach for their trates have been done.3 The third method for preparing plate- use may depend on clinical factors as well as the severity of lets is by the process of apheresis.4 One of the major advan- thrombocytopenia. tages of using apheresis platelets is that enough apheresis platelets can be derived from a single donor to provide a Prophylactic Platelet Transfusions single clinically relevant platelet transfusion dose to an A number of Clinical Practice Guidelines have been pub- adult thrombocytopenic patient. In contrast, to obtain the lished in both Europe and North America that provide “evi- equivalent number of transfused platelets required using dence-based” recommendations for the clinical use of plate- either the PRP or BC methodology requires the pooling of let transfusions. In general, they recommend prophylactic platelet concentrates from 4 to 6 different donors. platelet transfusions at a transfusion trigger of 10 × 109/ L.4,11,13,14 The use of therapeutic platelets is only recom- Relationship Between Platelet Count mended when there is significant bleeding or when an in- and Bleeding Risk vasive intervention is anticipated. The current thinking as to how circulating platelets con- It was not until the early 1970s that platelet transfu- trol thrombocytopenic bleeding is that they provide an sions became part of standard treatment in the manage- endothelial supportive function by plugging gaps in the ment of thrombocytopenic patients with a hypoproliferative endothelium of otherwise intact blood vessels.5,6 In experi- bone marrow.5 At that time, several observational studies mental animals with severe thrombocytopenia, electron- were conducted to determine the possible role of prophy- microscopic studies have shown that thrombocytopenia is lactic platelet transfusions to reduce the risk of clinical associated with the gradual thinning of the vessel wall en- bleeding. Based on such studies, it became common prac- dothelium over time, and that with ongoing thrombocy- tice to transfuse platelets prophylactically to patients with topenia gaps gradually occur between adjacent endothe- platelet counts below 20 × 109/L. It is important to note, lial cells.7,8 This thinning and fenestration in the endothe- however, that this practice was largely based on data from lium is accompanied with the on-going and increased use non-randomized studies, which indicated that bleeding was of circulating platelets to prevent the extravasation of red mainly evident in patients who had platelet counts of less blood cells (RBCs) through these gaps. Relevant data from than 5 × 109/L compared to patients with platelet counts thrombocytopenic animal models show the loss of RBCs between 5 and 100 × 109/L.10 Thus, even though the inci- into the lymphatics of thrombocytopenic animals.9 More- dence of bleeding across the range between 5 and 100 × over, there appears to be an inverse relationship between 109/L showed little difference, the threshold of 20 × 109/L increasing lymphatic RBC loss and decreasing platelet was widely adopted. Only in the late 1990s and early part counts.9 Additional evidence that indicates that the plate- of the twenty-first century were various studies done to try let count is relevant to bleeding risk is the observation that to establish an optimal prophylactic platelet count thresh- with progressively lower platelet counts there is an increas- old for prophylactic platelet transfusions in thrombocy- ing percentage of platelet loss from the circulation as the topenic patients.5,15-18 platelet count gradually declines.6 Moreover, a direct rela- The most widely quoted trial, which used a lower pro- tionship exists between the
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