The WAA apheresis registry was established in 2003 and an increasing number of centers have since then included their experience and data of their procedures. The registry now contains data of more than 74,000 apheresis procedures in more than 10,000 patients. This report shows that the indications for apheresis procedures are changing towards more oncological diagnoses and stem cell collections from patients and donors and less therapeutic apheresis procedures. In centers that continue to register, the total extent of apheresis procedures and patients treated have expanded during the latest years.

Blood establishments are responsible for the quality and safety of the blood collected and the final acceptance or deferral of a donor. All donors must undergo a screening process just prior to the blood donation. The elements are: (i) Identification of the donor and linking the identity to all the relevant documentation. (ii) Information timely provided so that the donor can decide whether to donate or to abstain. (iii) The donor health history must be evaluated by a questionnaire and complementary questions. (iv) The donor signs to confirm his/her responses. (v) A few physical parameters are assessed. (vi) Blood samples are collected for hemoglobin and markers for infectious agents. The questionnaire serves to detect exposures to hidden problems with possible consequences for the recipient. The interview clarifies answers and if the donor understood the information. Laboratory investigations of primary importance to the recipient involves screening assays for antigens, antibodies and RNA/DNA as legally required. Continuous improvement has led to shortening of the undetectable infectious period. There is continuous vigilance for emerging new infections or re‐emerging ‘old’ infections leading to modified deferral rules and development of new screening tests. In recent years there has also been modification of deferral criteria concerning sexual behavior with high risk for acquiring transfusion transmitted infections (TTI). Modelling of the risks of TTI in any given epidemiological situation and estimates of donor compliance precedes changes. Tools to study the effectiveness of the pre‐donation screening process include evaluation of recalled units, verified screening‐positive donors and compliance studies.

Ten Years of Experience With a Pathogen-reduction Technique In Platelets and Low Levels of Adverse Events

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.

Le procédé Intercept™ Blood System pour le plasma, utilisant l’amotosalen et les UVA, inactive un large spectre d’agents pathogènes et les leucocytes. En Suède, le plasma réfrigéré est utilisé jusqu’à 7jours en service d’urgence et est considéré comme cliniquement équivalent au PFC. Cette étude a examiné l’impact du procédé Intercept sur le plasma liquide stocké ensuite à 4°C pendant 2 semaines.

Background and Objectives A photochemical treatment process (PCT) utilizing amotosalen and UVA light (INTERCEPT (TM) 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.

Wir berichten über einen Patienten mit klinischen Zeichen einer medikamenteninduzierten Thrombozytopenie, bei welchem die Diagnose initial durch einen positiven HIT-Antikörpertest fehlgeleitet wurde. Der präsentierte Fall unterstreicht, dass ein positiver Antigentest bei HIT-Verdacht weiter untersucht werden muss, besonders bei niedriger Prä-Test-Wahrscheinlichkeit. Dies ist besonders wichtig, wenn der Antigentest nicht IgG-spezifisch ist. Wir empfehlen die Anwendung des klinischen „4 T-scores“ sowie eine weitere Laboraufbereitung von positiven HIT-Antigentesten mithilfe funktioneller Tests, die einzigen, welche die thrombozytenaktivierende Eigenschaft von HIT-Antikörpern nachweisen können (nicht aktivierende, niedrigtitrige IgG-Antikörper haben wahrscheinlich keine klinische Relevanz).

We report on a patient with clinical signs of drug-induced thrombocytopenia in whom the correct diagnosis was delayed by a positive HIT-antibody test. The clinical course demonstrates that a positive antigen test in suspected HIT has to be further examined, especially if pre-test probability is low. This is particularly important if the assay is not IgG-specific. We recommend the use of the "4T"- score as well as follow-up of positive HIT-antigen tests with functional assays which are the only tests that can demonstrate the platelet activating property of HIT-antibodies (nonactivating, low-titer IgG antibodies are probably clinically irrelevant).

Data from the WAA apheresis registry was collected from various apheresis procedures performed at 23 centres in 12 countries. The aim of this study was to investigate the extent of adverse events that can be expected when performing cytapheresis with focus on leukapheresis in relation to other procedures.

• S-303 RBCs had improved in vitro quality compared to IR RBCs with respect to potassium leakage and hemolysis post processing and throughout the storage period while containing less plasma protein. • The low plasma free hemoglobin for S-303 RBCs may result in reduced vasoconstriction due to nitric oxide binding and the low extracellular potassium may be of benefit for neonates and patients with renal failure.

Evaluation Of Maual Pooling Of 8 Buffy-Coats For Double-Dosespooled Pathogen-Reduced Platelet Concentrates

Evaluation of In Vitro Platelet Function in INTERCEPT Treated Platelet Units Containing 8 x 10(11) Platelets Using the INTERCEPT Platelet Processing Set with Dual Storage Containers

Background and Objectives Keeping a small stock of liquid plasma readily available for transfusion is common practise in Sweden. We report data on complement activation markers in plasma components during storage in the liquid state and the kinetics of C3a-desArg after transfusion of autologous plasma with high content of C3a-desArg. Material and Methods Plasma components were prepared by apheresis or from whole blood. C3 fragments (C3a-desArg, C3d, g, iC3), and soluble terminal complement complex (sC5b-9) were investigated. C3a-desArg kinetics was investigated in regular apheresis donors. Results Apheresis plasma prepared by membrane centrifugation had significantly higher level of C3a-desArg, C3d, g and sC5b-9 from day 0 and low iC3, than plasma prepared by other methods. By storage day 7, C3a-desArg -levels were above the reference value in 88% of all components. After re-infusion of autologous plasma with high C3a-desArg content, there were rapid a1 and a2-distribution followed by a slower b-elimination phase. Conclusion Plasma components prepared by different methods and stored in the liquid phase differ significantly in the amount and timing of complement activation. C3a-desArg present in plasma is rapidly eliminated after transfusion. Autologous plasma could be used to study complement kinetics in different clinical situations.