title: Independent evaluation of tolerance of therapeutic plasma inactivated by amotosalen-HCl-UVA (Intercept ™) over a 5-year period of extensive delivery.
abstract: Amotosalen-HCl-UVA (AI) is a process to inactivate pathogens in therapeutic plasma (FFP). Tolerance is the main residual issue in FFP transfusion, and only large series observations are powered enough to identify significantly elevated levels of hazards. We report here on 15,133 new transfusions of AI-FFP, over the previously published 36,035, which in all represents one of the largest series observed by means of a highly standardized surveillance (51.168 observations). There is no noticeable difference in terms of tolerance of AI-FFP compared to 5875 transfusions of Quarantine (Q)-FFP. There was no significant difference in terms of advance events, between the two types of FFP (P = 0.98); further, no difference was recorded either when the total number of AI-FFP (51,168) was compared to the corresponding number of Q-FFP (5875; P = 0.62).
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: V
authors.initials: V
authors.lastname: Bost
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: P
authors.initials: P
authors.lastname: Chavarin
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: F
authors.initials: F
authors.lastname: Boussoulade
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: P
authors.initials: P
authors.lastname: Fabrigli
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: C
authors.initials: C
authors.lastname: Chabre
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: H
authors.initials: H
authors.lastname: Benamara
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: H
authors.initials: H
authors.lastname: Odent-Malaure
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.
authors.forename: D
authors.initials: D
authors.lastname: Legrand
authors.affiliation: Etablissement Français du Sang Auvergne-Loire, Saint-Etienne, France.|GIMAP-EA3064, Université de Lyon, Saint Etienne, France.
authors.forename: F
authors.initials: F
authors.lastname: Cognasse
authors.affiliation: GIMAP-EA3064, Université de Lyon, Saint Etienne, France.|Institut National de la Transfusion Sanguine, Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Garraud
mesh_terms: D001793:Blood Preservation / Q000009:adverse effects / Q000379:methods*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D005602:France; D011564:Furocoumarins / Q000009:adverse effects*; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D065227:Transfusion Reaction; D014466:Ultraviolet Rays / Q000009:adverse effects*
chemical_list: D011564:Furocoumarins; C118577:amotosalen
keywords: amotosalen; haemovigilance; pathogen reduction; safety; therapeutic plasma