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

Abstract

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.

Hemovigilância: a experiência da notificação de reações transfusionais em Hospital Universitário

“…These findings confirm the national literature (6) , which reports the same distribution pattern for both genders. It is important to note that no statistically significant differences between genders were found in the literature (9,(11)(12)(13) . Only in two studies there was a significant difference between genders found: in a cohort study, in which men represented 60% of individuals (14) , and in another study carried out in an accredited hospital in the state of Ceará, which consisted of 52.5% women (15) .…”

Study of CD69 antigen expression and integrity of leukocyte cellular membrane in stored platelet concentrates following irradiation and treatment with Mirasol® PRT System

“…In the case of platelets, these technologies are the Mirasol ® PRT System and Intercept ™ Blood System, which are also effective for T lymphocyte inactivation. 6,7 Literature reviews confirm that pathogen reduction technology methods (Mirasol ® PRT System and Intercept ™ Blood System) have proved effective for leukocyte inactivation in cellular blood components. This implies that pathogen inactivated PCs (with either the Mirasol ® PRT System or Intercept ™ Blood System) are as safe for patients at risk of TA-GvHD as irradiated PCs.…”

“…In some countries (France, Spain, Austria, Luxemburg), platelet concentrates (PCs) for high-risk patients are subjected exclusively to pathogen inactivation with the Mirasol ® PRT System or the Intercept ™ Blood System. 6,7 In Poland the Mirasol ® PRT System was introduced in 2009, first for fresh frozen plasma (FFP) then for PCs. The Mirasol ® PRT System is based on exposure to riboflavin (vitamin B2) and UV-light.…”

Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

“…Hemovigilance data demonstrate a low rate of adverse events with PR platelets, 12 and some studies fail to demonstrate increased bleeding or worse clinical outcomes for patients treated with PR platelets. 13,14 However, studies have shown an association between PR platelets and a reduction in 1-and 24-hour corrected count increments, increase in platelet refractoriness, decrease in time to next transfusion, and increase in platelet use.…”