title: Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use.
abstract: Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed.
authors.affiliation: Postgraduate School of Health Economics and Management (Altems), Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Americo
authors.initials: A
authors.lastname: Cicchetti
authors.affiliation: Health Technology Assessment Unit of "Gemelli" Teaching Hospital, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Berrino
authors.affiliation: Institute of Bioethics, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Casini
authors.affiliation: Postgraduate School of Health Economics and Management (Altems), Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Codella
authors.affiliation: Italian National Blood Centre, National Institute of Health, Rome, Italy.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Facco
authors.affiliation: Postgraduate School of Health Economics and Management (Altems), Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Fiore
authors.affiliation: Italian National Blood Centre, National Institute of Health, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Marano
authors.affiliation: Health Technology Assessment Unit of "Gemelli" Teaching Hospital, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Marchetti
authors.affiliation: Institute of Bioethics, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Midolo
authors.affiliation: Institute of Bioethics, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Minacori
authors.affiliation: Institute of Bioethics, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Refolo
authors.affiliation: Postgraduate School of Health Economics and Management (Altems), Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Romano
authors.affiliation: Postgraduate School of Health Economics and Management (Altems), Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Ruggeri
authors.affiliation: Institute of Bioethics, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Sacchini
authors.affiliation: Institute of Bioethics, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Antonio G
authors.initials: AG
authors.lastname: Spagnolo
authors.affiliation: Health Technology Assessment Unit of "Gemelli" Teaching Hospital, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Urbina
authors.affiliation: Italian National Blood Centre, National Institute of Health, Rome, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Vaglio
authors.affiliation: Italian National Blood Centre, National Institute of Health, Rome, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Grazzini
authors.affiliation: Italian National Blood Centre, National Institute of Health, Rome, Italy.
authors.forename: Giancarlo M
authors.initials: GM
authors.lastname: Liumbruno
mesh_terms: D000818:Animals; D001419:Bacteria / Q000302:isolation & purification; D058731:Blood Safety / Q000379:methods*; D001803:Blood Transfusion / Q000379:methods; D004203:Disinfection / Q000379:methods; D006801:Humans; D010949:Plasma / Q000382:microbiology* / Q000821:virology*; D065227:Transfusion Reaction; D014780:Viruses / Q000302:isolation & purification