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Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial

Authors

  • Edward Snyder,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Jeffrey McCullough,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Sherrill J. Slichter,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Ronald G. Strauss,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Ileana Lopez-Plaza,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Jin-Sying Lin,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Laurence Corash,

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • Maureen G. Conlan,

    Corresponding author
    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • SPRINT Study Group

    1. From the Yale University Medical School, Yale-New Haven Hospital, New Haven, Connecticut; the University of Minnesota, Minneapolis, Minnesota; the Puget Sound Blood Center and the University of Washington School of Medicine, Seattle, Washington; the DeGowin Blood Center, University of Iowa, Iowa City, Iowa; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; the University of Massachusetts Medical Center, Worcester, Massachusetts; and Cerus Corporation, Concord, California.
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  • This study was supported by Baxter and Cerus Corporations.

Maureen Conlan, MD, Cerus Corporation, 2411 Stanwell Drive, Concord, CA 94520; e-mail: maureen_conlan@cerus.com.

Abstract

BACKGROUND:  A photochemical treatment (PCT) method utilizing a novel psoralen, amotosalen HCl, with ultraviolet A illumination has been developed to inactivate viruses, bacteria, protozoa, and white blood cells in platelet (PLT) concentrates. A randomized, controlled, double-blind, Phase III trial (SPRINT) evaluated hemostatic efficacy and safety of PCT apheresis PLTs compared to untreated conventional (control) apheresis PLTs in 645 thrombocytopenic oncology patients requiring PLT transfusion support. Hemostatic equivalency was demonstrated. The proportion of patients with Grade 2 bleeding was not inferior for PCT PLTs.

STUDY DESIGN AND METHODS:  To further assess the safety of PCT PLTs, the adverse event (AE) profile of PCT PLTs transfused in the SPRINT trial is reported. Safety assessments included transfusion reactions, AEs, and deaths in patients treated with PCT or control PLTs in the SPRINT trial.

RESULTS:  A total of 4719 study PLT transfusions were given (2678 PCT and 2041 control). Transfusion reactions were significantly fewer following transfusion of PCT than control PLTs (3.0% vs. 4.1%; p = 0.02). Overall AEs (99.7% PCT vs. 98.2% control), Grade 3 or 4 AEs (79% PCT vs. 79% control), thrombotic AEs (3.8% PCT vs. 3.7% control), and deaths (3.5% PCT vs. 5.2% control) were comparable between treatment groups. Minor hemorrhagic AEs (petechiae [39% PCT vs. 29% control; p < 0.01] and fecal occult blood [33% PCT vs. 25% control; p = 0.03]) and skin rashes (56% PCT vs. 42% control; p < 0.001) were significantly more frequent in the PCT group.

CONCLUSION:  The overall safety profile of PCT PLTs was comparable to untreated PLTs.

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