title: Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial.
abstract: A nucleic acid-targeted photochemical treatment (PCT) using amotosalen HCl (S-59) and ultraviolet A (UVA) light was developed to inactivate viruses, bacteria, protozoa, and leukocytes in platelet components. 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. A total of 103 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. More 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 8 test and reference transfusions was not statistically significantly different between treatment groups (13,100 +/- 5400 vs 14,900 +/- 6200, P =.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% confidence interval [CI], -3.1 to 6.1 x 10(9)/L, P =.53) and 24-hour (95% CI, -1.3 to 6.5 x 10(9)/L, P =.19) posttransfusion platelet count. Platelet transfusion dose, pretransfusion storage duration, and patient size were significant covariates (P <.001) for posttransfusion platelet counts. Clinical hemostasis, hemorrhagic adverse events, and overall adverse events were not different between the treatment groups. 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.
authors.affiliation: Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.
authors.forename: Dick
authors.initials: D
authors.lastname: van Rhenen
authors.forename: Hans
authors.initials: H
authors.lastname: Gulliksson
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cazenave
authors.forename: Derwood
authors.initials: D
authors.lastname: Pamphilon
authors.forename: Per
authors.initials: P
authors.lastname: Ljungman
authors.forename: Harald
authors.initials: H
authors.lastname: Klüter
authors.forename: Hans
authors.initials: H
authors.lastname: Vermeij
authors.forename: Mies
authors.initials: M
authors.lastname: Kappers-Klunne
authors.forename: Georgine
authors.initials: G
authors.lastname: de Greef
authors.forename: Michel
authors.initials: M
authors.lastname: Laforet
authors.forename: Bruno
authors.initials: B
authors.lastname: Lioure
authors.forename: Kathryn
authors.initials: K
authors.lastname: Davis
authors.forename: Stephane
authors.initials: S
authors.lastname: Marblie
authors.forename: Veronique
authors.initials: V
authors.lastname: Mayaudon
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Flament
authors.forename: Maureen
authors.initials: M
authors.lastname: Conlan
authors.forename: Lily
authors.initials: L
authors.lastname: Lin
authors.forename: Peyton
authors.initials: P
authors.lastname: Metzel
authors.forename: Don
authors.initials: D
authors.lastname: Buchholz
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
mesh_terms: D000328:Adult; D001424:Bacterial Infections / Q000517:prevention & control* / Q000635:transmission; D001787:Blood Group Incompatibility; D001793:Blood Preservation; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion; D005260:Female; D011564:Furocoumarins; D006470:Hemorrhage / Q000453:epidemiology; D006487:Hemostasis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010777:Photochemistry; D017319:Photosensitizing Agents; D010976:Platelet Count; D017713:Platelet Transfusion / Q000379:methods*; D013048:Specimen Handling / Q000379:methods*; D013921:Thrombocytopenia / Q000628:therapy; D013997:Time Factors; D014466:Ultraviolet Rays; D014777:Virus Diseases / Q000517:prevention & control* / Q000635:transmission
chemical_list: D011564:Furocoumarins; D017319:Photosensitizing Agents; C118577:amotosalen