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A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment.

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Knutson, F Osselaer, Jean-Claude [UCL] Pierelli, L Lozano, M Cid, J Corash, L

(eng) BACKGROUND AND OBJECTIVES: 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. MATERIALS AND 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. CONCLUSION: 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.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2015
Language Anglais
Journal information "Vox Sanguinis : international journal of transfusion medicine" - Vol. 109, no. 4, p. 343-352 (2015)
Peer reviewed yes
Publisher Wiley-Blackwell Publishing Ltd. ((United Kingdom) Oxford)
issn 0042-9007
e-issn 1423-0410
Publication status Publié
Affiliations UCL - SSS/IREC/MONT - Pôle Mont Godinne
UCL - (MGD) Centre de transfusion sanguine
MESH Subject Adolescent ; Furocoumarins ; Humans ; Infant ; Male ; Middle Aged ; Photosensitizing Agents ; Platelet Transfusion ; Prospective Studies ; Ultraviolet Rays ; Adult ; Aged ; Aged, 80 and over ; Blood Platelets ; Blood Safety ; Child ; Child, Preschool ; Female
Keywords INTERCEPT; Amotosalen; Haemovigilance; Pathogen inactivation; Platelets; Safety
Links
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Bibliographic reference Knutson, F ; Osselaer, Jean-Claude ; Pierelli, L ; Lozano, M ; Cid, J ; et. al. A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment.. In: Vox Sanguinis : international journal of transfusion medicine, Vol. 109, no. 4, p. 343-352 (2015)
Permanent URL http://hdl.handle.net/2078.1/174850