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Transfusion. 2005 Sep;45(9):1443-52.

Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set.

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1
Institute of Transfusion Medicine and Immunology, Red Cross Blood Service of Baden Württemberg-Hessen, Faculty of Clinical Medicine Mannheim, University of Heidelberg, Friedrich-Ebert-Strasse 107, 68167 Mannheim, Germany. k.janetzko@blutspende.de

Abstract

BACKGROUND:

This multicenter, randomized, controlled, double-blind Phase III clinical study evaluated the therapeutic efficacy and safety of apheresis platelets (PLTs) photochemically treated (PCT) with amotosalen and ultraviolet A light (INTERCEPT Blood System, Baxter Healthcare Corp.) compared with conventional apheresis PLTs (reference).

STUDY DESIGN AND METHODS:

Forty-three patients with transfusion-dependent thrombocytopenia were randomly assigned to receive either PCT or reference PLT transfusions for up to 28 days.

RESULTS:

The mean 1- and 24-hour corrected count increments were lower in response to PCT PLTs (not significant). When analyzed by longitudinal regression analysis, the estimated effect of treatment on 1-hour PLT count was a decrease of 7.2 x 10(9) per L (p = 0.05) and on 24-hour PLT count a decrease of 7.4 x 10(9) per L (p = 0.04). Number, frequency, and dose of PLT transfusions; acute transfusion reactions; and adverse events were similar between the two groups. There was no transfusion-associated bacteremia. Four PCT patients experienced clinical refractoriness; however, only one exhibited lymphocytotoxicity assay seroconversion. Antibodies against potential amotosalen-related neoantigens were not detected.

CONCLUSION:

PCT PLTs provide effective and safe transfusion support for thrombocytopenic patients.

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