Frequent plateletpheresis does not clinically significantly decrease platelet counts in donors

Louis M. Katz · Kim Palmer · Emily McDonnell · Andy Kabat

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Blood donation and transfusion practices Platelet Disorders and Treatments Blood transfusion and management

Abstract

BACKGROUND: In October 2005, the US Food and Drug Administration (FDA) issued draft guidance on collecting platelets (PLTs) by automated methods. The FDA proposed limiting collections to 24 components, rather than 24 procedures, annually with up to 3 components per procedure. The rationale was from literature suggesting frequent PLT collection resulted in significant declines in donor PLT counts. Additional requirements for minimal interdonation intervals were proposed. STUDY DESIGN AND METHODS: Plateletpheresis records at a regional blood center with predonation PLT counts were used to assess the impact of the restriction on PLT collections. They were reviewed to demonstrate the effects of collection frequency, number of products collected, and interdonation interval on donor PLT counts. Total protein and albumin levels were compared in a subset of 24-times-per-year PLT donors and control whole-blood donors. RESULTS: A limit of 24 components would require replacement of approximately 20 percent of the donor base to recover lost components. No clinically important decrease in PLT counts before donation was seen in donors donating multiple PLT components up to 24 times per year, regardless of interdonation interval. No frequent donor was deferred for a PLT count less than 150 x 10(9) per L. Short interdonation intervals were associated with statistically but not clinically important decreases in PLT counts. Protein levels were not distinguishable between PLT donors and controls. CONCLUSION: The proposed restrictions are not required to prevent thrombocytopenia in frequent PLT donors and would adversely impact the supply of apheresis PLTs. Protein levels are maintained in these high-frequency donors.

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2001Sustained decreases in platelet count associated with multiple, regular plateletpheresis donations

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2012Donor safety in triple plateletpheresis: results from the German and Austrian Plateletpheresis Study Group multicenter trial 2014Changes in pre- and post-donation haematological parameters in plateletpheresis donors 2016Recovery of Platelet Count among Apheresis Platelet Donors 2012Demographic, laboratory, and operational variables that influence short‐ and long‐term plateletpheresis yields 2008Risks of clinically significant thrombocytopenia and/or lymphocytopenia in donors after multiple plateletpheresis collections 2013Evaluation of donor factors contributing to plateletpheresis yields among apheresis platelet donors 2013Feasibility of applying the 2day deferral for repeat plateletpheresis: Indian perspective

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