Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set.
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.
Janetzko
Karin
K
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
Cazenave
Jean-Pierre
JP
Klüter
Harald
H
Kientz
Daniel
D
Michel
Martine
M
Beris
Photis
P
Lioure
Bruno
B
Hastka
Jan
J
Marblie
Stephane
S
Mayaudon
Veronique
V
Lin
Lily
L
Lin
Jin-Sying
JS
Conlan
Maureen G
MG
Flament
Jocelyne
J
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
D000906:Antibodies; D011564:Furocoumarins; C118577:amotosalen