Director of Transfusion Medicine, Director of Apheresis, Associate Director of Pathology Residency Program Mayo Clinic Florida Atlantic Beach, Florida, United States
Background/Case Studies: Pathogen reduced (PR) platelets, plasma, and cryoprecipitate have been approved by the Food and Drug Administration (FDA) for clinical use in the United States (USA) in recent years. Examples include INTERCEPT PR platelets, plasma, and cryoprecipitate (performed via amotosalen-ultraviolet A methodology), and Octaplas PR plasma (performed via solvent/detergent methodology). Non-PR cellular products, including platelets, are irradiated for certain at-risk patient populations to prevent Transfusion-Associated Graft-versus-Host Disease (TA-GVHD). According to the PR manufacturers, PR is considered equivalent to irradiation for the prevention of TA-GVHD and irradiation of PR platelets is unnecessary. The number of hospitals currently using these products in the USA and site irradiation practices of PR products is not known. We designed a detailed survey to elucidate current practices.
Study
Design/Methods: The CAP Transfusion, Apheresis, and Cellular Therapy Committee developed a 13-question survey and distributed it to 3509 transfusion services as a part of the CAP J-C proficiency test in Fall 2024. Key questions included individual site use of PR products and the number of sites that would irradiate these products. A chi-square test was used to compare categorical variables, and the Kruskal-Wallis test was used for continuous variables, with p< .05 considered as significant.
Results/Findings: We received survey responses from 2771 institutions (79% response rate). The majority of participants were from the USA (2315/2771, 83.5%). Among USA-respondents, 1635/2121 (77.1%) offered PR platelets, 118/2082 (5.7%) offered PR plasma, and 110/2079 (5.3%) offered PR cryoprecipitate. Of the USA laboratories that offer these products, 255/1530 (16.7%) report that they irradiate PR platelets, 12/109 (11.0%) irradiate PR plasma, and 10/100 (10.0%) irradiate PR cryoprecipitate prior to distribution to patients.
Conclusions: To our knowledge, this survey represents the largest and most detailed contemporary survey of PR product use. The survey reveals that a majority of surveyed hospitals now offer PR platelets, and considerably fewer offer PR plasma or cryoprecipitate. We identified that nearly 1/5th of PR-product-using respondents would irradiate PR platelet products for patients, despite their known status as equivalent to irradiation. We further identified that some institutions also irradiate non-cellular PR products. This survey reveals that national PR education efforts may be needed to avoid unnecessary use of laboratory resources.