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.

Apheresis with different procedures and devices are used for a variety of indications that may have different adverse events (AEs). The aim of this study was to clarify the extent and possible reasons of various side effects based on data from a multinational registry. The WAA-apheresis registry data focus on adverse events in a total of 50846 procedures in 7142 patients (42% women). AEs were graded as mild, moderate (need for medication), severe (interruption due to the AE) or death (due to AE). More AEs occurred during the first procedures versus subsequent (8.4 and 5.5%, respectively). AEs were mild in 2.4% (due to access 54%, device 7%, hypotension 15%, tingling 8%), moderate in 3% (tingling 58%, urticaria 15%, hypotension 10%, nausea 3%), and severe in 0.4% of procedures (syncope/hypotension 32%, urticaria 17%, chills/fever 8%, arrhythmia/asystole 4.5%, nausea/vomiting 4%). Hypotension was most common if albumin was used as the replacement fluid, and urticaria when plasma was used. Arrhythmia occurred to similar extents when using plasma or albumin as replacement. In 64% of procedures with bronchospasm, plasma was part of the replacement fluid used. Severe AEs are rare. Although most reactions are mild and moderate, several side effects may be critical for the patient. We present side effects in relation to the procedures and suggest that safety is increased by regular vital sign measurements, cardiac monitoring and by having emergency equipment nearby.

PCT with 150 microM S-59 and a 3 J/cm(2) UVA treatment does not adversely affect in vitro properties of BC PCs stored at 22 degrees C for 7 days. The PCT process inactivated bacteria and HIV-1 inoculated into the BC PCs. These results extend the earlier reported efficacy of PCT apheresis PCs to BC PCs.

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.

No abstract

Using the freeze-thaw method, optimal preparation of PL with regard to the concentration of growth factors was achieved at Cycles 3 to 5. Based on our findings, the clinical significance of using a greater number of cycles is likely limited.

With current anticoagulants, storage of whole blood at temperatures of 25 to 30 degrees C before separation causes a great and rapid loss of 2,3 DPG and an accumulation of acid metabolites. In a hold of blood for >4 hours, rapid cooling is desirable to avoid initial loss of 2,3 DPG.

Blood components prepared with the Reveos from fresh or overnight-held WB meet quality criteria without any relevant difference between the two groups. The Reveos system has the potential to increase efficacy and standardization of blood component preparation.