title: Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial.
abstract: We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P =.001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 x 10(3) PCT versus 16.0 x 10(3) control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P <.001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control; P =.02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.
authors.affiliation: University of Minnesota, MMC 609, 420 Delaware Street SE, Minneapolis, MN 55455, USA. mccul001@umn.edu
authors.forename: Jeffrey
authors.initials: J
authors.lastname: McCullough
authors.forename: David H
authors.initials: DH
authors.lastname: Vesole
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Benjamin
authors.forename: Sherrill J
authors.initials: SJ
authors.lastname: Slichter
authors.forename: Alvaro
authors.initials: A
authors.lastname: Pineda
authors.forename: Edward
authors.initials: E
authors.lastname: Snyder
authors.forename: Edward A
authors.initials: EA
authors.lastname: Stadtmauer
authors.forename: Ileana
authors.initials: I
authors.lastname: Lopez-Plaza
authors.forename: Steven
authors.initials: S
authors.lastname: Coutre
authors.forename: Ronald G
authors.initials: RG
authors.lastname: Strauss
authors.forename: Lawrence T
authors.initials: LT
authors.lastname: Goodnough
authors.forename: Joy L
authors.initials: JL
authors.lastname: Fridey
authors.forename: Thomas
authors.initials: T
authors.lastname: Raife
authors.forename: Ritchard
authors.initials: R
authors.lastname: Cable
authors.forename: Scott
authors.initials: S
authors.lastname: Murphy
authors.forename: Frank
authors.initials: F
authors.lastname: Howard
authors.forename: Kathryn
authors.initials: K
authors.lastname: Davis
authors.forename: Jin-Sying
authors.initials: JS
authors.lastname: Lin
authors.forename: Peyton
authors.initials: P
authors.lastname: Metzel
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
authors.forename: Antonis
authors.initials: A
authors.lastname: Koutsoukos
authors.forename: Lily
authors.initials: L
authors.lastname: Lin
authors.forename: Donald H
authors.initials: DH
authors.lastname: Buchholz
authors.forename: Maureen G
authors.initials: MG
authors.lastname: Conlan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets / Q000187:drug effects*; D017848:Blood-Borne Pathogens; D002648:Child; D017707:Erythrocyte Transfusion; D005260:Female; D011564:Furocoumarins / Q000494:pharmacology*; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D010777:Photochemistry; D017713:Platelet Transfusion / Q000009:adverse effects; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000628:therapy*
chemical_list: D011564:Furocoumarins; C118577:amotosalen