TY - JOUR
T1 - Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use
AU - Cicchetti, Americo
AU - Berrino, Alexandra
AU - Casini, Marina
AU - Codella, Paola
AU - Facco, Giuseppina
AU - Fiore, Alessandra
AU - Marano, Giuseppe
AU - Marchetti, Marco
AU - Midolo, Emanuela
AU - Minacori, Roberta
AU - Refolo, Pietro
AU - Romano, Federica
AU - Ruggeri, Matteo
AU - Sacchini, Dario
AU - Spagnolo, Antonio Gioacchino
AU - Urbina, Irene Luz
AU - Vaglio, Stefania
AU - Grazzini, Giuliano
AU - Liumbruno, Giancarlo M.
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - health technology assessment,
KW - pathogen reduction
KW - health technology assessment,
KW - pathogen reduction
UR - http://hdl.handle.net/10807/82180
U2 - 10.2450/2016.0065-16
DO - 10.2450/2016.0065-16
M3 - Article
SN - 1723-2007
VL - 14
SP - 287
EP - 386
JO - Blood Transfusion
JF - Blood Transfusion
ER -