title: A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment.
abstract: OBJECTIVE
  A photochemical treatment process (PCT) utilizing amotosalen and UVA light (INTERCEPT(™) Blood System) has been developed for inactivation of viruses, bacteria, parasites and leucocytes that can contaminate blood components intended for transfusion. The objective of this study was to further characterize the safety profile of INTERCEPT-treated platelet components (PCT-PLT) administered across a broad patient population.
  
  
  METHODS
  This open-label, observational haemovigilance programme of PCT-PLT transfusions was conducted in 21 centres in 11 countries. All transfusions were monitored for adverse events within 24 h post-transfusion and for serious adverse events (SAEs) up to 7 days post-transfusion. All adverse events were assessed for severity (Grade 0-4), and causal relationship to PCT-PLT transfusion.
  
  
  RESULTS
  Over the course of 7 years in the study centres, 4067 patients received 19,175 PCT-PLT transfusions. Adverse events were infrequent, and most were of Grade 1 severity. On a per-transfusion basis, 123 (0.6%) were classified an acute transfusion reaction (ATR) defined as an adverse event related to the transfusion. Among these ATRs, the most common were chills (77, 0.4%) and urticaria (41, 0.2%). Fourteen SAEs were reported, of which 2 were attributed to platelet transfusion (<0.1%). No case of transfusion-related acute lung injury, transfusion-associated graft-versus-host disease, transfusion-transmitted infection or death was attributed to the transfusion of PCT-PLT.
  
  
  CONCLUSIONS
  This longitudinal haemovigilance safety programme to monitor PCT-PLT transfusions demonstrated a low rate of ATRs, and a safety profile consistent with that previously reported for conventional platelet components.
authors.affiliation: Department of Immunology, Genetics, and Pathology, Uppsala University, Uppsala, Sweden.
authors.forename: F
authors.initials: F
authors.lastname: Knutson
authors.affiliation: Cliniques Universitaires de Mont Godinne, Universite Catholique de Louvain, Yvoir, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Osselaer
authors.affiliation: Department of Experimental Medicine, Sapienza University of Roma, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Pierelli
authors.affiliation: Department of Hemotherapy and Hemostasis, CDB, IDIBAPS, Hospital Clinic, Barcelona, Spain.
authors.forename: M
authors.identifier: http://orcid.org/0000-0003-2593-833X
authors.initials: M
authors.lastname: Lozano
authors.affiliation: Department of Hemotherapy and Hemostasis, CDB, IDIBAPS, Hospital Clinic, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Cid
authors.affiliation: EFS Bretagne, Rennes, France.
authors.forename: R
authors.initials: R
authors.lastname: Tardivel
authors.affiliation: EFS Auvergne Loire, St. Etienne, France.
authors.forename: O
authors.initials: O
authors.lastname: Garraud
authors.affiliation: Department of Immunology and Transfusion Medicine, University of Bergen, Bergen, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Hervig
authors.affiliation: Blood Transfusion Centre of Slovenia, Ljubljana, Slovenia.
authors.forename: D
authors.initials: D
authors.lastname: Domanovic
authors.affiliation: Blood Transfusion Centre of Slovenia, Ljubljana, Slovenia.
authors.forename: M
authors.initials: M
authors.lastname: Cukjati
authors.affiliation: Blood Bank, National University Hospital, Reykjavik, Iceland.
authors.forename: S
authors.initials: S
authors.lastname: Gudmundson
authors.affiliation: Blood Bank, National University Hospital, Reykjavik, Iceland.
authors.forename: I B
authors.initials: IB
authors.lastname: Hjalmarsdottir
authors.affiliation: Transfusion Centre of Galicia, Santiago de Compostela, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Castrillo
authors.affiliation: Transfusion Centre of Galicia, Santiago de Compostela, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Gonzalez
authors.affiliation: Servico de Imuno-Hemoterapia, Instituto Portugues de Oncologia de Lisboa, Lisbon, Portugal.
authors.forename: D
authors.initials: D
authors.lastname: Brihante
authors.affiliation: Servico de Imuno-Hemoterapia, Instituto Portugues de Oncologia de Lisboa, Lisbon, Portugal.
authors.forename: M
authors.initials: M
authors.lastname: Santos
authors.affiliation: Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.
authors.forename: P
authors.initials: P
authors.lastname: Schlenke
authors.affiliation: Cerus Corporation, Concord, CA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Elliott
authors.affiliation: Cerus Corporation, Concord, CA, USA.
authors.forename: J-S
authors.initials: JS
authors.lastname: Lin
authors.affiliation: Cerus Corporation, Concord, CA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Tappe
authors.affiliation: Cerus Corporation, Concord, CA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Stassinopoulos
authors.affiliation: Cerus Corporation, Concord, CA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Green
authors.affiliation: Cerus Corporation, Concord, CA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Corash
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets / Q000187:drug effects / Q000528:radiation effects; D058731:Blood Safety / Q000379:methods* / Q000706:statistics & numerical data; D002648:Child; D002675:Child, Preschool; D005260:Female; D011564:Furocoumarins / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D017319:Photosensitizing Agents / Q000009:adverse effects*; D017713:Platelet Transfusion / Q000009:adverse effects* / Q000706:statistics & numerical data; D011446:Prospective Studies; D014466:Ultraviolet Rays / Q000009:adverse effects*
chemical_list: D011564:Furocoumarins; D017319:Photosensitizing Agents; C118577:amotosalen
keywords: INTERCEPT; amotosalen; haemovigilance; pathogen inactivation; platelets; safety