| Infusion of P-Capt prion-filtered red blood cell products demonstrate acceptable in vivo viability and no evidence of neoantigen formation. | |
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MedLine Citation:
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PMID: 21492178 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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BACKGROUND: Transmission of variant Creutzfeldt-Jacob disease (vCJD) is a major concern in blood transfusion. The P-Capt filter has been shown to remove around 4 log ID(50) prion infectivity from prion-spiked human red blood cells (RBCs). STUDY DESIGN AND METHODS: Two independent, single-center, randomized, open-label studies were designed to analyze the safety of P-Capt-filtered RBCs. RBCs prepared from leukoreduced whole blood from 43 eligible subjects were randomly assigned to P-Capt filtration and/or storage in plasma or SAGM and stored for 28 or 42 days. Stored RBCs were analyzed for in vivo 24-hour recovery, hemolysis, metabolic variables, blood group antigen expression, neoantigen formation, and safety after autologous infusion. RESULTS: Mean P-Capt filtration times for leukoreduced RBCs were 41 (SAGM) to 51 (plasma) minutes. Thirteen of 14 subjects receiving P-Capt-filtered RBCs had 24-hour RBC recoveries of 75% or more after 42-day storage, with a mean hemolysis of less than 0.6%. No loss of RBC antigen expression or formation of neoantigens was observed. In both studies, RBCs had white blood cell counts of less than 1 × 10(6) /unit after leukofiltration. P-Capt prion filtration provided an additional greater than 0.8 log leukoreduction. No serious or unexpected adverse events were observed after infusion of P-Capt-filtered full-volume RBC units. CONCLUSIONS: P-Capt-filtered, stored RBCs demonstrated acceptable viability and no detectable neoantigen expression, immunogenic responses. or safety issues after infusion of a complete unit. The additional filtration time and modest reduction in RBC content are within acceptable levels for implementation in countries with transfusion transmission of vCJD. |
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Authors:
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Jose A Cancelas; Neeta Rugg; P Gayle Pratt; D Nicole Worsham; Joan C Pehta; Kate Banks; Robertson D Davenport; W John Judd |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-4-14 |
Journal Detail:
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Title: Transfusion Volume: - ISSN: 1537-2995 ISO Abbreviation: - Publication Date: 2011 Apr |
Date Detail:
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Created Date: 2011-4-15 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0417360 Medline TA: Transfusion Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2011 American Association of Blood Banks. |
Affiliation:
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From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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