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Background and Objectives  A photochemical treatment process ( PCT ) utilizing amotosalen and  UVA  light ( INTERCEPT  ™   B lood  S ystem) 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 ( SAE s) 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  ATR s, the most common were chills (77, 0·4%) and urticaria (41, 0·2%). Fourteen  SAE s 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  ATR s, and a safety profile consistent with that previously reported for conventional platelet components.

vox sanguinis

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