title: Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies.
abstract: BACKGROUND
  Two noninferiority, randomized, controlled trials were conducted in parallel comparing the safety and efficacy of platelets treated with Intercept or Mirasol pathogen-reduction technologies versus standard platelets.
  
  
  METHODS
  The primary endpoint was the percentage of hematology patients who developed World Health Organization Grade 2 or greater bleeding. A noninferiority margin of 11% was chosen based on expected Grade 2 or greater bleeding in 20% of controls. The study was closed for financial restrictions before reaching the planned sample size of 828 patients, and an intention-to-treat analysis was conducted on 424 evaluable patients.
  
  
  RESULTS
  In the Intercept trial (113 treated vs. 115 control patients), the absolute risk difference in Grade 2 or greater bleeding was 6.1%, with an upper one-sided 97.5% confidence limit of 19.2%. The absolute risk difference in the Mirasol trial (99 treated vs. 97 control patients) was 4.1%, and the upper one-sided 97.5% confidence limit was 18.4%. Neither absolute risk difference was statistically significant. In both trials, posttransfusion platelet count increments were significantly lower in treated versus control patients. Mean blood component use in treated patients versus controls was 54% higher (95% confidence interval, 36%-74%; Intercept) and 34% higher (95% confidence interval, 16%-54%; Mirasol) for platelets and 23% higher (95% confidence interval, 8%-39%; Intercept) and 32% higher (95% confidence interval, 10%-57%; Mirasol) for red blood cells. Unexpected reactions and adverse events were not reported. Mortality did not differ significantly between treated and control patients.
  
  
  CONCLUSIONS
  Although conclusions on noninferiority could not be drawn due to low statistical power, the study provides additional information on the safety and efficacy of pathogen-reduced platelets treated with two commercial pathogen-reduction technologies.
authors.affiliation: Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Rebulla
authors.affiliation: Italian National Blood Center, National Institute of Health, Rome, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Vaglio
authors.affiliation: Blood Transfusion Service and Hematology 1, IRCCS San Martino University Hospital, Genoa, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Beccaria
authors.affiliation: Blood Transfusion Service and Hematology, IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonfichi
authors.affiliation: Blood Transfusion Service and Hematology 1, IRCCS San Martino University Hospital, Genoa, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Carella
authors.affiliation: Blood Transfusion Service and Hematology, Federico II University Hospital, Naples, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Chiurazzi
authors.affiliation: Blood Transfusion Service and Hematology, Umberto I Hospital, Rome, Italy.
authors.forename: Serelina
authors.initials: S
authors.lastname: Coluzzi
authors.affiliation: Hematology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico and University of Milan, Milan, Italy.
authors.forename: Agostino
authors.initials: A
authors.lastname: Cortelezzi
authors.affiliation: Blood Transfusion Service and Hematology, University Hospital, Verona, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Gandini
authors.affiliation: Blood Transfusion Service and Hematology, Umberto I Hospital, Rome, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Girelli
authors.affiliation: Blood Transfusion Service and Hematology, Federico II University Hospital, Naples, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Graf
authors.affiliation: Blood Transfusion Service and Hematology, IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Isernia
authors.affiliation: Italian National Blood Center, National Institute of Health, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Marano
authors.affiliation: Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Marconi
authors.affiliation: Blood Transfusion Service and Hematology, University Hospital, Verona, Italy.
authors.forename: Rachele
authors.initials: R
authors.lastname: Montemezzi
authors.affiliation: Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Olivero
authors.affiliation: Blood Transfusion Service and Hematology, University Hospital, Verona, Italy.
authors.forename: Marianna
authors.initials: M
authors.lastname: Rinaldi
authors.affiliation: Blood Transfusion Service and Hematology, IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Salvaneschi
authors.affiliation: Blood Transfusion Service and Hematology, Federico II University Hospital, Naples, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Scarpato
authors.affiliation: Blood Transfusion Service and Hematology 1, IRCCS San Martino University Hospital, Genoa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Strada
authors.affiliation: Laboratory of Medical Statistics and Biometry, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Silvano
authors.initials: S
authors.lastname: Milani
authors.affiliation: Italian National Blood Center, National Institute of Health, Rome, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Grazzini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000985:Antisepsis / Q000379:methods* / Q000592:standards; D001793:Blood Preservation / Q000379:methods; D018562:Disease Transmission, Infectious / Q000517:prevention & control; D005260:Female; D006470:Hemorrhage / Q000209:etiology* / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion / Q000009:adverse effects* / Q000379:methods; D055815:Young Adult