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

Janetzko, Karin; Cazenave, Jean-Pierre; Klüter, Harald; Kientz, Daniel; Michel, Martine; Beris, Photis; Lioure, Bruno; Hastka, Jan; Marblie, Stephane; Mayaudon, Veronique; Lin, Lily; Lin, Jin-Sying; Conlan, Maureen G.; Flament, Jocelyne

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). Forty-three patients with transfusion-dependent thrombocytopenia were randomly assigned to receive either PCT or reference PLT transfusions for up to 28 days. 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 × 109 per L (p = 0.05) and on 24-hour PLT count a decrease of 7.4 × 109 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. PCT PLTs provide effective and safe transfusion support for thrombocytopenic patients.

HEMAPHERESIS; THERAPEUTICS; BLOOD platelets; PATIENTS; THROMBOCYTOPENIA; CELL-mediated lympholysis

Transfusion, 2005, Vol 45, Issue 9, p1443

0041-1132

Academic Journal

10.1111/j.1537-2995.2005.00550.x