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Prepublished online as a Blood First Edition Paper on November 27, 2002; DOI 10.1182/blood-2002-03-0932.

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2002-03-0932v1
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Submitted March 25, 2002
Accepted October 26, 2002

Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial

Dick van Rhenen, Hans Gulliksson, Jean-Pierre Cazenave, Derwood Pamphilon, Per Ljungman, Harald Klueter, Hans Vermeij, Mies Kappers-Klunne, Georgine de Greef, Michel Laforet, Bruno Lioure, Kathryn Davis, Staphane Marblie, Veronique Mayaudon, Jocelyne Flament, Maureen Conlan, Lily Lin, Peyton Metzel, Don Buchholz, and Laurence Corash*

Sanquin Blood Bank South West Region, Rotterdam, The Netherlands
Huddinge University Hospital, Stockholm, Sweden
Etablissement Francais du Sang EFS-Alsace, Strasbourg, France
Institute for Transfusion Science, Bristol, United Kingdom
Institute for Transfusion Medicine and Immunology, University of Heidelberg, Faculty of Clinical Medicine, Mannheim, Germany
Erasmus Medical Center, Rotterdam, The Netherlands
Cerus Corp., Concord, CA, USA
University of Washington, Seattle, WA, USA
Baxter Healthcare Corp., Deerfield, IL, USA

* Corresponding author; email: larry_corash{at}ceruscorp.com.

Background: A nucleic acid targeted photochemical treatment (PCT) using amotosalen HCl (S-59) and ultraviolet (UVA) light was developed to inactivate viruses, bacteria, protozoa, and leukocytes in platelet components. Methods: We conducted a controlled, randomized, double-blinded trial in thrombocytopenic patients requiring repeated platelet transfusions for up to 56 days of support to evaluate the therapeutic efficacy and safety of platelet components prepared with the buffy coat method using this pathogen inactivation process. Results: One hundred and three patients received one or more transfusions of either PCT-Test (311 transfusions) or conventional-Reference (256 transfusions) pooled, leukoreduced platelet components stored for up to 5 days before transfusion. Greater than 50% of the PCT platelet components were stored for 4 to 5 days prior to transfusion. The mean 1-hour corrected count increment for up to the first eight Test and Reference transfusions was not statistically significantly different between treatment groups (13,100 ± 5,400 vs. 14,900 ± 6,200, p = 0.11). By longitudinal regression analysis for all transfusions, equal doses of Test and Reference components did not differ significantly with respect to the 1-hour (95% CI: -3.1 to 6.1 x 109/L, p=0.53) and 24-hour post-transfusion platelet count (95% CI: -1.3 to 6.5 x 109/L, p = 0.19). Platelet transfusion dose, pre-transfusion storage duration, and patient size were significant covariates (p<0.001) for post-transfusion platelet counts. Clinical hemostasis, hemorrhagic adverse events, and overall adverse events were not different between the treatment groups. Conclusions: Platelet components prepared with PCT offer the potential to further improve the safety of platelet transfusion using technology compatible with current methods to prepare buffy coat platelet components.


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