Summary Bacteria in platelet components (PC) may result in transfusion‐related sepsis (TRS). Pathogen inactivation of PC with amotosalen (A‐PC) can abrogate the risk of TRS and hence facilitate storage to 7 d. A randomized, controlled, double‐blinded trial to evaluate the efficacy and safety of A‐PC stored for 6–7 d was conducted. Patients were randomized to receive one transfusion of conventional PC (C‐PC) or A‐PC stored for 6–7 d. The primary endpoint was the 1 h corrected count increment (CCI) with an acceptable inferiority of 30%. Secondary endpoints included 1‐ and 24‐h count increment (CI), 24‐h CCI, time to next PC transfusion, red blood cell (RBC) use, bleeding and adverse events. 101 and 100 patients received A‐PC or C‐PC respectively. The ratio of 1‐h CCI (A‐PC:C‐PC) was 0·87 (95% confidence interval: 0·73, 1·03) demonstrating non‐inferiority (P = 0·007), with respective mean 1‐h CCIs of 8163 and 9383; mean 1‐h CI was not significantly different. Post‐transfusion bleeding and RBC use were not significantly different (P = 0·44, P = 0·82 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2·2 vs. 2·3 d, P = 0·72). Storage of A‐PCs for 6–7 d had no impact on platelet efficacy.

clinicaltrials.gov Identifier: NCT01789762.

Routine transfusion of PCT-PLT is well-tolerated in a wide range of patients. ATRs related to PCT-PLT transfusion were infrequent and most were of mild severity.

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.

HLA immunization is a common complication of transfusion therapy in 30% to 60% of oncohematologic patients. Evidence shows that leukocytes present in cellular blood products are the main component involved in the occurrence of HLA immunization, and several studies showed that leukocyte-poor blood products are less able to induce it. However, leukocyte-poor platelet concentrates obtained by conventional techniques, ie, centrifugation, frequently have a high level of remaining leukocytes. Cotton wool filter Imugard IG 500 can be used to obtain leukocyte-poor cellular blood products. The technique is easy to perform, even in an emergency, and can be used with either packed RBCs or platelet concentrates. Means of 97%, 92%, and 76% elimination of leukocytes are obtained for packed RBCs, pooled standard platelet concentrates, and single-donor platelet concentrates, respectively. Patients were randomized to receive either standard (control group) or filtered (leukocyte-poor group) blood products. Of 112 randomized patients, 69 were evaluable, 35 in the control group and 34 in the leukocyte-poor group. Both groups are comparable according to age, diagnosis, sex ratio, previous transfusions, and pregnancies. There is a significant difference in regard to the HLA immunization rate (31.4% in the control v 11.7% in the leukocyte-poor group, P less than .05) and frequency of refractoriness to platelet transfusions (46.6% v 11.7%, P less than .05). We conclude that this filtration technique can be an efficient means to reduce the HLA immunization rate in polytransfused oncohematologic patients.