title: Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set.
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).
  
  
  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.
  
  
  CONCLUSIONS
  PCT PLTs provide effective and safe transfusion support for thrombocytopenic patients.
authors.affiliation: 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
authors.forename: Karin
authors.initials: K
authors.lastname: Janetzko
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cazenave
authors.forename: Harald
authors.initials: H
authors.lastname: Klüter
authors.forename: Daniel
authors.initials: D
authors.lastname: Kientz
authors.forename: Martine
authors.initials: M
authors.lastname: Michel
authors.forename: Photis
authors.initials: P
authors.lastname: Beris
authors.forename: Bruno
authors.initials: B
authors.lastname: Lioure
authors.forename: Jan
authors.initials: J
authors.lastname: Hastka
authors.forename: Stephane
authors.initials: S
authors.lastname: Marblie
authors.forename: Veronique
authors.initials: V
authors.lastname: Mayaudon
authors.forename: Lily
authors.initials: L
authors.lastname: Lin
authors.forename: Jin-Sying
authors.initials: JS
authors.lastname: Lin
authors.forename: Maureen G
authors.initials: MG
authors.lastname: Conlan
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Flament
mesh_terms: D000328:Adult; D000368:Aged; D000906:Antibodies; D001424:Bacterial Infections / Q000517:prevention & control*; D001781:Blood Component Removal; D017707:Erythrocyte Transfusion; D005260:Female; D011564:Furocoumarins / Q000009:adverse effects / Q000276:immunology; D006470:Hemorrhage / Q000209:etiology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010777:Photochemistry; D010976:Platelet Count; D017713:Platelet Transfusion / Q000009:adverse effects; D013921:Thrombocytopenia / Q000150:complications / Q000628:therapy*; D014466:Ultraviolet Rays
chemical_list: D000906:Antibodies; D011564:Furocoumarins; C118577:amotosalen