A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment

Authors

  • Jean C. Osselaer,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Nathalie Messe,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Tor Hervig,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Jose Bueno,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Emma Castro,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Aurora Espinosa,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Patrizia Accorsi,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Klaus Junge,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Michele Jacquet,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Jocelyne Flament,

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Laurence Corash

    1. From the Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium; Haukeland University Hospital, Bergen, Norway; Centro de Transfusión, Cruz Roja Española, Madrid, Spain; St Olav Hospital, Trondheim, Norway; Centro Trasfusionale, Ospedale di Pescara, Pescara, Italy; Omega Mediation, Offenbach, Germany; Transfusion Therapies, Baxter Healthcare, Nivelles, Belgium; and Medical Affairs, Cerus Corp., Concord, California.
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  • Supported by research grants from Cerus Corp.

  • Disclosures: Jocelyne Flament was an employee of Baxter Healthcare Corp. during conduct of the study. Laurence Corash was an employee of Cerus Corp. during conduct of the study.

Laurence Corash, MD, Medical Affairs, Cerus Corp., 2411 Stanwell Drive, Concord, CA 94520; e-mail: larry_corash@cerus.com.

Abstract

BACKGROUND: Inactivation of pathogens and white blood cells in platelet (PLT) components with amotosalen and UVA light (INTERCEPT, Cerus Europe BV) has entered clinical practice in European blood centers. A prospective cohort study was implemented to characterize the safety profile of this new PLT component in a broad patient population.

STUDY DESIGN AND METHODS: Apheresis or buffy-coat PLT components were leukoreduced, suspended in approximately 35 percent plasma and 65 percent PLT additive solution, and treated with the INTERCEPT process. Blood centers were requested to complete a safety data form after each transfusion.

RESULTS: Data for 5106 INTERCEPT components administered to 651 patients were monitored. A total of 5051 (98.9%) transfusions and 609 (93.5%) patients had no reported reactions. Fifty-five (1.1%) transfusions were associated with adverse events, and 42 (0.8%) were possibly, probably, or related to the PLT transfusion. Adverse events occurred in 42 (6.4%) patients, but in only 32 (4.9%) patients was a causal relationship to PLT transfusion established. One reaction was serious, and no deaths were related to PLT transfusion. Among the transfusions reactions, the most frequent clinical events in descending frequency were chills, fever, dermatologic reactions, dyspnea, nausea or vomiting, and hypotension. No episodes of transfusion-related acute lung injury were reported.

CONCLUSIONS: In this cohort study, 99.2 percent of transfusions were without reactions attributed to PLTs. INTERCEPT PLTs exhibited a safety profile similar to that previously reported for conventional PLT components.

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