In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution

Authors

  • Larry J. Dumont,

    Corresponding author
    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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    • These authors contributed equally to this work.

  • Jose A. Cancelas,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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    • These authors contributed equally to this work.

  • Sharon Graminske,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Kenneth D. Friedman,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Ralph R. Vassallo,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Pamela H. Whitley,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Neeta Rugg,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Deborah F. Dumont,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Louise Herschel,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Alan H. Siegal,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Zbigniew M. Szczepiorkowski,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Logan Fender,

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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  • Anna Razatos

    1. From Research and Development, Terumo BCT, Inc., Lakewood, Colorado; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the American Red Cross, Mid-Atlantic Region, Norfolk, Virginia; The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; the Hoxworth Blood Center, Cincinnati, Ohio; and the Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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Larry J. Dumont, MBA, PhD, Center for Transfusion Medicine Research, Department of Pathology, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756; e-mail: larry.j.dumont@hitchcock.org.

Abstract

BACKGROUND: Platelets (PLTs) stored in additive solutions (PASs) may reduce the risk of several plasma-associated adverse transfusion reactions such as allergic reactions and potentially transfusion-associated lung injury. The objective of this study was to determine the in vitro characteristics and the in vivo radiolabeled recovery and survival of apheresis PLTs (APs) stored in a new PAS and compare the latter to Food and Drug Administration (FDA) criteria.

STUDY DESIGN AND METHODS: Hyperconcentrated APs were collected from healthy subjects in a paired crossover study comparing PAS (35% plasma) and 100% plasma-stored APs (Part 1) up to 7 days and, in Part 2, to determine the in vivo recovery and survival of PAS stored AP at 5 days compared to fresh PLT controls. In vitro and in vivo assays were performed following standard methods.

RESULTS: Sixty-six and 25 evaluable subjects successfully completed Parts 1 and 2, respectively. pH for PAS AP was maintained above 6.6 for 5 days of storage. P-selectin values were consistent with published values for commonly transfused PLT products. The PAS in vivo PLT recovery (54.3 ± 8.1%) was 86.7% of the fresh control, and survival (6.4 ± 1.3 days) was 78.0% of the fresh control, both meeting the FDA performance criteria.

CONCLUSION: APs stored in PAS with 35% plasma carryover maintained pH over 5 days of storage and met current FDA criteria for radiolabeled recovery and survival. The use of PAS for storage of single-donor PLTs in clinical practice represents an acceptable transfusion product that reduces the volume of plasma associated with PLT transfusion.

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