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Background and Objectives: Nucleic acid amplification testing (NAT), in blood services context, is used for the detection of viral and parasite nucleic acids to reduce transfusion‐transmitted infections. This project reviewed NAT for screening blood donations globally. Materials and Methods: A survey on NAT usage, developed by the International Society of Blood Transfusion Working Party on Transfusion‐transmitted Infectious Diseases (ISBT WP‐TTID), was distributed through ISBT WP‐TTID members. Data were analysed using descriptive statistics. Results: Forty‐three responses were received from 32 countries. Increased adoption of blood donation viral screening by NAT was observed over the past decade. NAT‐positive donations were detected for all viruses tested in 2019 (proportion of donations positive by NAT were 0.0099% for human immunodeficiency virus [HIV], 0.0063% for hepatitis C virus [HCV], 0.0247% for hepatitis B virus [HBV], 0.0323% for hepatitis E virus [HEV], 0.0014% for West Nile virus [WNV] and 0.00005% for Zika virus [ZIKV]). Globally, over 3100 NAT‐positive donations were identified as NAT yield or solely by NAT in 2019 and over 22,000 since the introduction of NAT, with HBV accounting for over half. NAT‐positivity rate was higher in first‐time donors for all viruses tested except WNV. During 2019, a small number of participants performed NAT for parasites (Trypanosoma cruzi, Babesia spp., Plasmodium spp.). Conclusion: This survey captures current use of blood donation NAT globally. There has been increased NAT usage over the last decade. It is clear that NAT contributes to improving blood transfusion safety globally; however, there is a need to overcome economic barriers for regions/countries not performing NAT. [ABSTRACT FROM AUTHOR]

Background and Objectives: Although screening of donated blood for syphilis is almost universally applied, its cost‐effectiveness is questioned because of the low prevalence of transfusion‐transmitted syphilis and a widespread belief that the syphilis‐causing bacterium Treponema pallidum is very vulnerable to cold storage. Since the latter claim is not yet supported by a systematic review, we investigated whether syphilis can be transmitted via transfusion following prolonged (cold or room temperature) storage of blood products. Materials and Methods: MEDLINE, PMC and NCBI bookshelf (PubMed interface), Cochrane Library, Embase, Web of Science and CINAHL were searched up to 17 January 2023. Results: Nine experimental animal studies and one observational human study were included. Meta‐analysis showed that storing artificially infected human (six studies; risk ratio [RR] = 0.37, 95% confidence interval [CI]: 0.22–0.64, p = 0.0003) or rabbit (two studies; RR = 0.08, 95% CI: 0.01 to 0.55, p = 0.01) blood for more than 72 h before intratesticular injection significantly decreased the number of recipient animals that develop syphilis. Nonetheless, the possibility of syphilis transmission remained for up to 7 days. Differences could not be found for rabbit plasma (p = 0.60) or naturally infected rabbit blood (p = 0.28). There was limited evidence from one study in favour of the storage of artificially infected human platelets for over 72 h at cold temperatures (RR = 0.13, 95% CI: 0.03–0.52, p = 0.004) but not at room temperature (p = 0.12). Conclusion: Even though the infectivity of T. pallidum‐spiked blood may decrease after 72 h of cold storage, the possibility for transfusion‐transmitted syphilis may remain for several days after. The evidence is very uncertain, and conclusions are hindered by a lack of sufficiently powered studies and studies in humans. In addition, T. pallidum concentrations used in animal studies may be unrealistically high. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVES:Red-blood-cell (RBC) transfusion is associated with lung injury, which is further exacerbated by mechanical ventilation. Manufacturing methods of blood products differ globally and may play a role in the induction of pulmonary cell activation through alteration of the immunomodulatory property of the products. Here, the effect of different manufacturing methods on pulmonary cell activation was investigated in an in vitro model of mechanical ventilation. MATERIALS AND METHODS:Pulmonary type II cells were incubated with supernatant from fresh and old RBC products obtained via whole blood filtration (WBF), red cell filtration (RCF), apheresis-derived (AD) or whole blood-derived (WBD) methods. Lung cells were subjected to 25% stretch for 24 h. Controls were non-stretched or non-incubated cells. RESULTS:Fresh but not old AD products and WBF products induce lung cell production of pro-inflammatory cytokines and chemokines, which was not observed with WBD or RCF products. Effects were associated with an increased amount of platelet-derived vesicles and an increased thrombin-generating capacity. Mechanical stretching of lung cells induced more severe cell injury compared to un-stretched controls, including alterations in the cytoskeleton, which was further augmented by incubation with AD products. In all read-out parameters, RCF products seemed to induce less injury compared to the other products. CONCLUSIONS:Our findings show that manufacturing methods of RBC products impact pulmonary cell activation, which may be mediated by the generation of vesicles in the product. We suggest RBC manufacturing method may be an important factor in understanding the association between RBC transfusion and lung injury.

Background and Objectives: The management of intraoperative blood loss in the surgical treatment of paediatric hip dysplasia is resource intensive. There are numerous clinical factors that impact the need for intraoperative transfusion. Identification of patient and surgical factors associated with increased blood loss may reduce the unnecessary use of resources. This study aimed to identify factors predictive of intraoperative transfusion in children undergoing hip dysplasia surgery. Materials and Methods: This is a single‐centre retrospective review of patients undergoing surgery for hip dysplasia from 1 January 2012 to 15 April 2021. Patient demographic factors, anaesthetic, surgical and transfusion histories were reviewed. Multivariable logistic regression analysis was performed to identify factors predictive of allogeneic red blood cell transfusion requirements during the intraoperative period. Results: This study includes 595 patients who underwent open surgery for hip dysplasia, including 297 (52.6%) classified as developmental dysplasia (DD) and 268 (47.3%) as neuromuscular (NM) with a mean age of 9.1 years (interquartile range 3–14). Intraoperative allogeneic transfusion was identified in 26/297 (8.8%) DD and 73/268 (27.2%) NM patients. Adjusted factors associated with increased odds of intraoperative transfusion were NM (odds ratio [OR] = 2.96, 95% confidence interval [CI] [1.76, 5.00]) and the number of osteotomies performed (OR = 1.82/osteotomy, 95% CI [1.40, 2.35]). Adjusted factors that reduced the odds of transfusion were the use of antifibrinolytics (OR = 0.35, 95% CI [0.17, 0.71]) and regional anaesthesia (OR = 0.52, 95% CI [0.29, 0.94]). Conclusion: For children undergoing surgery for hip dysplasia, the number of osteotomies performed is predictive of the need for allogeneic blood transfusion. Antifibrinolytics and regional anaesthesia are associated with reduced risk for allogeneic blood transfusion. Blood management initiatives, such a preoperative optimization of haemoglobin and the use of antifibrinolytics, could target patients at increased risk of intraoperative bleeding and transfusion. [ABSTRACT FROM AUTHOR]

Background: Prior research on red blood cell (RBC) storage duration and clinical outcomes in paediatric cardiac surgery has shown conflicting results. The purpose of this study was to evaluate whether blood stored for a longer duration is harmful in these patients. Methods: We performed a retrospective cohort study of paediatric patients undergoing cardiac surgery at our institution between January 2011 and June 2015. Patients were stratified based on whether they were transfused RBCs stored for ≤15 days (fresher blood) or >15 days (older blood). The primary outcome was composite morbidity, with prolonged length of stay (LOS) as a secondary outcome. Subgroup analyses were performed after stratification by RBC transfusion volume (≤2 vs. >2 RBC units). Multivariable logistic regression models were used to assess the impact of RBC storage duration on composite morbidity and prolonged LOS. Results: Of 461 patients, 122 (26·5%) received fresher blood and 339 (73·5%) received older blood. The overall rate of composite morbidity was 18·0% (n = 22) for patients receiving fresher blood and 13·6% (n = 46) for patients receiving older blood (P = 0·24). In the risk‐adjusted model, patients receiving older blood did not exhibit an increased risk of composite morbidity (OR: 0·74, 95% CI: 0·37–1·47, P = 0·40) or prolonged LOS (OR: 0·72, 95% CI: 0·38–1·35, P = 0·30) compared to patients receiving fresher blood. Similar results were seen after stratification by RBC transfusion volume. Conclusions: Transfusing RBCs stored for a longer duration was not associated with an increased risk of morbidity or prolonged LOS in paediatric cardiac surgery patients. [ABSTRACT FROM AUTHOR]

Blood transfusion remains a routine life‐saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion‐transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process. Consequently, the need for high‐quality, safe and well‐performing IVDs for use in transfusion medicine arises, accompanied by the need for tight regulations in this domain. In the European Union, the new IVD Regulation will replace the existing IVD Directive within a five‐year transitional period. Manufacturers of IVDs are expected to fully comply with the new Regulation by 26 May 2022. In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease‐specific IVDs for blood screening laboratories. [ABSTRACT FROM AUTHOR]

Background and objectives: Commercial blood bags are predominantly made of polyvinyl chloride (PVC) plasticized with di(2‐ethylhexyl) phthalate (DEHP). DEHP is favourable for storage of red blood cells (RBC). Historically, removal of DEHP from blood bags has been linked to unacceptable haemolysis levels. Oncoming regulatory restrictions for DEHP due to toxicity concerns increase the urgency to replace DEHP without compromising RBC quality. Di(2‐ethylhexyl) terephthalate (DEHT) is one suggested substitute. The aim of this study was to compare PVC‐DEHT to PVC‐DEHP blood bags using additive solutions saline–adenine–glucose–mannitol (SAGM) and phosphate–adenine–glucose–guanosine–saline–mannitol (PAGGSM), to determine whether DEHT can maintain acceptable component quality. Materials and methods: RBC concentrates (N = 64), platelet concentrates (N = 16) and fresh frozen plasma (N = 32) were produced from whole blood collected into either DEHT or DEHP plasticized systems. Using a pool‐and‐split study design, pairs of identical RBC content were created within each plasticizer arm and assigned either SAGM or PAGGSM. Storage effects were assessed weekly for 49 days (RBC), 7 days (platelets) and before/after freezing (plasma). Results: Though haemolysis was slightly higher in DEHT, all study arms remained below half of the European limit 0·8%. K+ was lower in DEHT than in DEHP independent of additive solution. The metabolic parameters were not influenced by choice of plasticizer. Platelet activation/metabolism and plasma content were similarly preserved. Conclusion: Our study demonstrates that the plasticizer DEHT provides adequate blood component quality. We propose DEHT as a strong future candidate for replacement of DEHP in blood bags. [ABSTRACT FROM AUTHOR]

Background and objectives: The antioxidant power measurement can be useful to validate the execution of the pathogen inactivation treatment of platelet concentrates. The aim of this study is to evaluate the technology on different blood preparations including INTERCEPT and Mirasol treatments that are in routine use in Belgium and Luxemburg. Materials and methods: The antioxidant power measurement was tested on 78 apheresis platelet concentrates and 54 pools of buffy‐coats‐derived platelet concentrates before and after INTERCEPT treatment. In addition, 100 Reveos platelet pools were tested before and after Mirasol treatment. The antioxidant power was quantified electrochemically using disposable devices and was expressed as equivalent ascorbic acid concentration. Results: Mean results for apheresis platelet concentrates were of 90 ± 14 and 35 ± 10 µmol/l eq. ascorbic acid before and after INTERCEPT treatment, respectively. The mean results for pools of buffy‐coats‐derived platelet concentrates were of 81 ± 10 and 29 ± 4 eq. µmol/l ascorbic acid before and after INTERCEPT treatment, respectively. For buffy‐coats‐derived platelet concentrates treated by Mirasol technology, the mean results were of 98 ± 11 and 32 ± 10 µmol/l eq. ascorbic acid before and after illumination, respectively. Conclusion: The antioxidant power significantly decreases with pathogen inactivation treatments for platelet concentrates treated by INTERCEPT or Mirasol technologies. [ABSTRACT FROM AUTHOR]

Background and Objectives: Patient blood (more accurately: haemoglobin, Hb) management (PBM) aims to optimize endogenous Hb production and to minimize iatrogenic Hb loss while maintaining patient safety and optimal effectiveness of medical interventions. PBM was adopted as policy for patients by the World Health Organization (WHO), and, all the more, should be applied to healthy donors. Materials and Methods: Observational data from 489 bone marrow (BM) donors were retrospectively analysed, and principles of patient blood management were applied to healthy volunteer BM donations. Results and Conclusion: We managed to render BM aspiration safe for donors, notably completely avoiding the collection of autologous blood units and blood transfusions through iron management, establishment and curation of high‐yield aspiration technique, limitation of collection volume to 1·5% of donor body weight and development of volume prediction algorithms for the requested cell dose. [ABSTRACT FROM AUTHOR]

Background: Anaemia at delivery is a strong modifiable risk factor for transfusion in women with a postpartum haemorrhage (PPH). A Maternity Patient Blood Management (PBM) Practice Based Evidence Clinical Practice Improvement (CPI) was conducted to optimize antenatal haemoglobin and iron stores prior to delivery. Methods: Australian maternity PBM CPI resources (featuring algorithms on diagnosing iron deficiency with both haemoglobin and ferritin screening, as well as information on oral iron therapy for maternity patients) were introduced at a major tertiary hospital from November 2016 to March 2017. To assess the effectiveness of these resources on haemoglobin and iron stores, an interrupted time series (ITS) analysis was conducted for 11,263 deliveries from January 2016 to June 2018. The evaluation timeframe was divided into baseline (pre‐CPI), pilot (during CPI) and post‐pilot (post‐CPI). Results: In 1550 patients with haemoglobin and ferritin in the first trimester, non‐anaemic iron deficiency was detected in 416 women (26·8%) and iron deficiency anaemia (IDA) in 239 women (15·41%) throughout the whole study period. The number of women with IDA increases as pregnancy progresses but applying PBM CPI shows a reduction of IDA rate in all trimesters and reduction in anaemia at delivery in the post‐pilot period from baseline. More anaemic episodes were observed in the postpartum period compared to the first trimester. ITS analysis for the whole study period showed a clinically significant increase in the monthly average predelivery haemoglobin of 0·9 g/l (P = 0·16). This corresponded with a reduction in the monthly rate of anaemic patients by 18% (P = 0·12). There was a significant decrease in the rates of anaemia at delivery and decrease in red cell transfusion in anaemic women, even though the number of women with PPH was stable. The factors associated with red cell transfusion are anaemia at delivery (P < 0·001) and the incidence of PPH (P < 0·001). Conclusions: The maternity PBM CPI resources had a clinically relevant but not statistically significant effect in optimizing antenatal haemoglobin and decreasing the risk of predelivery anaemia. This study demonstrates how a CPI can modify one risk factor for blood loss, which is the anaemia at delivery, and subsequent transfusion in the perinatal period. [ABSTRACT FROM AUTHOR]

Background: This multi‐national study evaluated changes in platelet (PLT) unit distributions at 12 national or regional blood collectors over a 10‐year period. Methods: Data on the total number of PLT distributions, the collection method, that is apheresis vs whole blood‐derived (WBD), the PLT unit characteristics and post‐collection modifications were obtained from 12 national or regional blood collectors from 2008 through 2017. Individual WBD PLT units were converted to apheresis equivalent units (i.e. a dose of PLTs) by dividing by 4, the typical pool size; WBD units that were pooled before distribution were counted as a single dose. Results: Overall at these 12 blood collectors, the total number of PLTs distributed in 2008 was 1 373 200, which rose by 10·2% to 1 513 803 in 2017. The Japanese Red Cross, which distributes only apheresis PLTs, had a 13·4% increase in the number of distributions between the years 2008 and 2017, while the other 11 blood collectors combined demonstrated a 6·8% increase in distributions between these two years. Between the years 2008 and 2017, the changes in the proportion of apheresis, platelet‐rich plasma and buffy coat PLT distributions were −29·9%, −70·7% and 80·0%, respectively. Conclusion: The number of PLT distributions increased during the 10‐year study period despite prophylactic PLT transfusion thresholds having remained fairly consistent over the last decade. Perhaps this increase is in part driven by increased administration of platelets to patients with massive haemorrhage or an increase in stem cell transplantation. The use of buffy coat PLTs is increasing at these collectors. [ABSTRACT FROM AUTHOR]

Abbreviations HDFN haemolytic disease of the fetus and newborn IUT intrauterine transfusion RBCs red bloob cells Introduction Intrauterine transfusion (IUT) is a blood administration technique performed mainly for treatment of fetal anaemia and, occasionally, thrombocytopenia. Practice and evidence regarding pre-transfusion testing of fetal blood, product preparation and post-transfusion monitoring are limited and variable. Malaysia The indication for IUT in our institution has to date been limited to red cell alloimmunization due to anti-D. Switzerland IUT is performed based on the following indications: red cell alloimmunization, fetal anaemia due to parvovirus, feto-maternal haemorrhage, twin-to-twin transfusion syndrome (TTTS), alpha thalassaemia, platelet transfusion and twin anaemia polycythemia sequence (TAPS). As a rule at the Neonatal Intensive Care Unit, it must be documented the transfused volumes and the number of IUTs done, in order to know the values of the Ht. and Hb. in cord blood due to the possibility of transfusion therapy (transfusion of RBC or/and an exchange transfusion). [Extracted from the article]

Background and Objective: Severe acute respiratory distress syndrome coronavirus‐2 (SARS‐CoV‐2), the causative agent of coronavirus disease 2019 (COVID‐19), is a member of the coronavirus family. Coronavirus infections in humans are typically associated with respiratory illnesses; however, viral RNA has been isolated in serum from infected patients. Coronaviruses have been identified as a potential low‐risk threat to blood safety. The Mirasol Pathogen Reduction Technology (PRT) System utilizes riboflavin and ultraviolet (UV) light to render blood‐borne pathogens noninfectious, while maintaining blood product quality. Here, we report on the efficacy of riboflavin and UV light against the pandemic virus SARS‐CoV‐2 when tested in both plasma and platelets units. Materials and Methods: Stock SARS‐CoV‐2 was grown in Vero cells and inoculated into either plasma or platelet units. Those units were then treated with riboflavin and UV light. The infectious titres of SARS‐CoV‐2 were determined by plaque assay using Vero cells. A total of five (n = 5) plasma and three (n = 3) platelet products were evaluated in this study. Results: In both experiments, the measured titre of SARS‐CoV‐2 was below the limit of detection following treatment with riboflavin and UV light. The mean log reductions in the viral titres were ≥3·40 and ≥4·53 for the plasma units and platelet units, respectively. Conclusion: Riboflavin and UV light effectively reduced the titre of SARS‐CoV‐2 in both plasma and platelet products to below the limit of detection in tissue culture. The data suggest that the process would be effective in reducing the theoretical risk of transfusion transmitted SARS‐CoV‐2. [ABSTRACT FROM AUTHOR]

Background and Objectives: A worldwide pandemic of coronavirus disease 2019 (COVID‐19) has affected millions of people. A 'closed‐off management' protocol has been launched nationwide in China to cope with this major public health emergency. However, these procedures may cause a crisis for blood donation and blood supply. In this study, we assessed the impact of the COVID‐19 pandemic on blood donation and supply in Zhejiang province, which could provide reference and insight for developing countermeasures in other countries. Materials and Methods: Blood donor and supply information from 38 blood centres during the Spring Festival of 2019 and 2020 were reviewed. A self‐administered questionnaire was carried out. Results: Due to the COVID‐19 pandemic, the number of whole blood donors dropped by 67%. The success rate of recruitment for donations dropped by 60%. Most respondents (81·2%) were worried about the 'possibility of acquiring COVID‐19 during blood donation'. The total amount of RBCs supply dropped by 65%. In the first week of the outbreak, the weekly amount of issued RBC units (10171·5 u) was almost six times higher than the collected units (1347·5 u). The mean haemoglobin value for RBCs transfusion was about 6·3 g/dl. About 4% of RBCs and 2·8% of frozen plasma were used in COVID‐19 patients. Conclusion: The secondary consequences of the COVID‐19 pandemic are blood shortages caused by the unavailability of blood donors, and this is likely to be replicated in many countries with high burdens of COVID‐19. Practical actions to broaden sources and reduce use for the global crisis must be taken proactively. [ABSTRACT FROM AUTHOR]

Background and objectives: Phlebotomy is a central task for blood donation; however, not all blood donors have veins that are easy to see or feel. This study aimed to determine whether use of a surgical skin marker to highlight the donors' vein location and direction prior to venepuncture increased blood donation success. Methods: All blood donors who participated in this study were eligible to donate according to Australian guidelines. Ten donor centres with phlebotomy success rates <95% were selected. A randomized cluster trial design assigned five sites to test the skin marking device and five sites as controls. Single‐use sterile Gentian violet skin marker pens were used to mark donors' veins. Phlebotomy site skin bacterial load after using the skin marking device was tested on a subset of 100 donors. Phlebotomy success rates and donor adverse events were recorded. Results: Of the control donors, 6993 had successful phlebotomies and 225 failed. Of the skin marker donors, 6998 had successful phlebotomies and 248 failed. No statistically significant differences in phlebotomy success were found between the two groups (OR: 0·91, 96·4% CI [96·0, 96·8], P‐value 0·348). Conclusion: The use of skin marker pens did not increase overall phlebotomy success rate. There was no increase in phlebotomy site skin bacterial load, and amendments to standard skin disinfection techniques were not required. Blood donors were not concerned about the pen mark on their arms. Generally, staff indicated that the markers may be valuable to assist with phlebotomies for donors with difficult or deep veins. [ABSTRACT FROM AUTHOR]

Therapeutic phlebotomy is the cornerstone of treatment for HFE haemochromatosis (HH). Current Australian Red Cross LifeBlood Service guidelines mandate measuring haemoglobin (Hb) levels prior to phlebotomy and if below 130 g/l in men or 120 g/l in women, donors are deferred from donating whole blood. Therapeutic donation below these levels may take place where both the treating doctor and a blood service medical officer approve. The aim of the current study was to determine whether adverse events are more frequent in those who undergo therapeutic phlebotomy below current Hb thresholds applied to volunteer therapeutic donors. A retrospective review of all therapeutic donations was undertaken for the financial year 2016–2017. The data were obtained through the Australian Red Cross Blood Service. Inclusion criteria were any donor between 16 and 70 years of age, weighing more than 50 kg and meeting blood service guidelines for donation. All adverse events recorded in an electronic quality system were obtained and associated with donor haemoglobin level. Statistical analyses were performed using analysis of variance or Fisher's exact test (GraphPad Prism). About 34 886 therapeutic phlebotomy donations occurred during 2016–2017, of whom the majority were referred for HH (34 089). In total, 365 of 34 886 donations (0·0105%) were complicated by an adverse event. A total of 305 (0·0087%) therapeutic donations occurred while below the lower limit of blood service Hb threshold for their respective genders. Of the donations that occurred below the blood service threshold, 3 of 305 (0·0098%) had an adverse event compared with 362 of 34 581 donations above the lower limit threshold (0·0105%, P = 0·99). The incidence of adverse events was not increased in the group which underwent therapeutic phlebotomy below the current Australian Red Cross Blood Service Hb threshold compared with those above threshold, indicating safety of treatment at Hb levels lower than currently recommended. [ABSTRACT FROM AUTHOR]

Background and Objectives: Responding to national and local pressures to reduce the amount of blood transfused, the haematology department of Oxford University Hospitals (OUH), UK implemented an electronic blood‐ordering system with clinical decision support. This intervention targeted junior doctors, giving regular feedback on their transfusion practices with respect to clinical guidelines. Methods: We evaluated the incremental costs of the intervention using interrupted time series methods to compare red blood cell and platelet usage before and after the intervention was implemented. Difference‐in‐differences analysis was used to control for external factors that would affect the use of blood products over time. Reductions in blood usage were balanced against intervention costs. Results: The base case analysis showed an average cost saving to the department of £89 304 annually as a result of the intervention. Scenario analyses suggested that the savings may have been greater still, had the increasing trend in blood use prior to the intervention continued in the absence of the intervention. Conclusion: An electronic blood‐ordering system with clinical decision support can reduce blood transfusions and associated healthcare costs. Focusing on improving junior doctors' transfusion practice is expected to have a knock‐on benefit in terms of dissemination of good transfusion practice both within their own department and others as they continue their training. [ABSTRACT FROM AUTHOR]

Background and Objectives: Blood services are tasked with efficiently maintaining a reliable blood supply, and there has been much debate over the use of incentives to motivate prosocial activities. Thus, it is important to understand the relative effectiveness of interventions for increasing donations. Materials and Methods: This systematic review used a broad search strategy to identify randomized controlled trials comparing interventions for increasing blood donations. After full‐text review, 28 trials from 25 published articles were included. Sufficient data for meta‐analysis were available from 27 trials. Monetary incentives were assumed to be equivalent regardless of value, and non‐monetary incentives were assumed to be equivalent regardless of type. Non‐incentive‐based interventions identified included existing practice, letters, telephone calls, questionnaires, and the combination of a letter & telephone call. A network meta‐analysis was used to pool the results from identified trials. A subgroup analysis was performed in populations of donors and non‐donors as sensitivity analyses. Results: The best performing interventions were letter & telephone call and telephone call‐only with odds ratios of 3·08 (95% CI: 1·99, 4·75) and 1·99 (95% CI: 1·47, 2·69) compared to existing practice, respectively. With considerable uncertainty around the pooled effect, we found no evidence that monetary incentives were effective at increasing donations compared to existing practice. Non‐monetary incentives were only effective in the donor subgroup. Conclusion: When pooling across modes of interventions, letter & telephone call and telephone call‐only are effective at increasing blood donations. The effectiveness of incentives remains unclear with limited, disparate evidence identified. [ABSTRACT FROM AUTHOR]

Background and objectives: Until recently, people in Australia with a history of injection drug use (IDU) were deferred indefinitely from donating blood. Knowledge gaps regarding policy non‐compliance and the prevalence of blood donation practices amongst people who inject drugs (PWID) precluded changes to this policy. We sought to address these gaps and to estimate the additional risk to Australia's blood supply associated with changing the indefinite deferral policy to 1 or 5 years since last injecting episode. Materials and methods: Data on blood donation amongst PWID were collected from 1853 interviews across two Australian studies of PWID conducted during 2015/16. Mathematical modelling was used to estimate the additional risk of hepatitis C (HCV)‐infected window period collections as a result of changing the deferral policy. Results: A very few (2–4%) study participants reported ever donating blood after ≥1 IDU episode. Changing the deferral policy from indefinite to 1 or 5 years was estimated to result in an additional 0·00000070 (95%CI: 0·00000033–0·00000165) or 0·00000020 (95%CI: 0·00000008–0·00000041) HCV‐positive window period collections per year, respectively. Conclusion: Changing Australia's indefinite deferral period to 1 or 5 years since last injecting episode poses a negligible increase in the risk of HCV‐infected window period collections from blood donors with a history of IDU. Our results informed a successful submission to the Australian regulator to change the deferral period from indefinite to 5 years since last injecting episode, a policy which came into effect in September 2018. [ABSTRACT FROM AUTHOR]

Background and objectives: Preoperative anaemia is an independent risk factor for a higher morbidity and mortality, a longer hospitalization and increased perioperative transfusion rates. Managing preoperative anaemia is the first of three pillars of Patient Blood Management (PBM), a multidisciplinary concept to improve patient safety. While various studies provide medical information on (successful) anaemia treatment pathways, knowledge of organizational details of diagnosis and management of preoperative anaemia across Europe is scarce. Materials and methods: To gain information on various aspects of preoperative anaemia management including organization, financing, diagnostics and treatment, we conducted a survey (74 questions) in ten hospitals from seven European nations within the PaBloE (Patient Blood Management in Europe) working group covering the year 2016. Results: Organization and activity in the field of preoperative anaemia management were heterogeneous in the participating hospitals. Almost all hospitals had pathways for managing preoperative anaemia in place, however, only two nations had national guidelines. In six of the ten participating hospitals, preoperative anaemia management was organized by anaesthetists. Diagnostics and treatment focused on iron deficiency anaemia which, in most hospitals, was corrected with intravenous iron. Conclusion: Implementation and approaches of preoperative anaemia management vary across Europe with a primary focus on treating iron deficiency anaemia. Findings of this survey motivated the hospitals involved to critically evaluate their practice and may also help other hospitals interested in PBM to develop action plans for diagnosis and management of preoperative anaemia. [ABSTRACT FROM AUTHOR]

Background and objectives: It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non‐remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established. Materials and methods: This review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis. Results: A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre‐donation transfusion‐transmissible infection (TTI) screening, potential non‐transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non‐disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information. Conclusion: Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid. [ABSTRACT FROM AUTHOR]

Background and objectives: Platelet transfusion is a standard medical therapy used to treat several bleeding disorders. However, a critical drawback is the dependency on donor‐derived platelets, which leads to concerns like insufficient availability and immunological complications. In vitro platelet production from hematopoietic progenitor cells (CD34) may represent a reasonable solution. Materials and methods: CD34+ cells were isolated from either buffy coat or peripheral blood and compared in terms of platelet production in vitro. The number and the quality of magnetically isolated CD34+ cells and their capability to differentiate into mature megakaryocytes were investigated using flow cytometry. Additionally, the functionality of megakaryocytes in term of in vitro platelet production was tested. Results: Similar purity and quantity of CD34+ cells was found after their isolation from both cell sources. In contrast, after 6 days of culture, enhanced number of CD34+ cells isolated from buffy coat compared with peripheral blood was observed (5·3 x 106 vs. 3·0 x 106, respectively). Interestingly, despite a comparable nuclear maturation phenotype, the yield of platelets released from buffy coat‐derived megakaryocytes was significantly higher than from peripheral blood cells (platelet yield pro MK: 7·2 vs. 2·7, respectively). Importantly, platelets produced from buffy coat‐derived cells could be activated by agonists. Conclusion: Haematopoietic progenitor cells isolated from buffy coat have increased yield of platelets released from mature megakaryocytes and enhanced in vitro functionality, compared with peripheral blood‐derived cells. Our study, suggests that buffy coat, obtained during blood donation processing, might be a promising source of megakaryocytes for in vitro platelet production. [ABSTRACT FROM AUTHOR]

Background and objectives: Patient Blood Management (PBM) aims to optimize the care of patients who might need a blood transfusion. The International Consensus Conference on PBM (ICC‐PBM) aimed to develop evidence‐based recommendations on three topics: preoperative anaemia, red blood cell transfusion thresholds and implementation of PBM programmes. This paper reports how evidence‐based methodologies and technologies were used to enhance shared decision‐making in formulating recommendations during the ICC‐PBM. Materials & Methods: Systematic reviews on 17 PICO (Population, Intervention, Comparison, Outcomes) questions were conducted by a Scientific Committee (22 international topic experts and one methodologist) according to GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methodology. Evidence‐based recommendations were formulated using Consensus Development Conference methodology. Results: We screened 17 607 references and included 145 studies. The overall certainty in the evidence of effect estimates was generally low or very low. During the ICC, plenary sessions (100–200 stakeholders from a range of clinical disciplines and community representatives) were followed by closed sessions where multidisciplinary decision‐making panels (>50 experts and patient organizations) formulated recommendations. Two chairs (content‐expert and methodologist) moderated each session and two rapporteurs documented the discussions. The Evidence‐to‐Decision template (GRADEpro software) was used as the central basis in the process of formulating recommendations. Conclusion: This ICC‐PBM resulted in 10 clinical and 12 research recommendations supported by an international stakeholder group of experts in blood transfusion. Systematic, rigorous and transparent evidence‐based methodology in a formal consensus format should be the new standard to evaluate (cost‐) effectiveness of medical treatments, such as blood transfusion. [ABSTRACT FROM AUTHOR]

Background and objectives: The perception of transfusion‐transmitted infections (TTIs) is sensitive to various concerns besides the probability and impact of infection, and some of these concerns may be ethically relevant. This paper aims to advance thinking about blood safety policies by exploring and explaining stakeholders' reasons to consider TTI risks tolerable or intolerable. Materials and methods: Inspired by critical empirical ethics and phenomenological hermeneutics, we held interviews and focus group discussions to explore the moral experience of policymakers, hematologists, blood donors and recipients. Respondents were invited to discuss general concerns about the blood supply, to address the tolerability of TTI risks compared with other hazards and to comment on the costs of blood safety. Arguments for tolerance or intolerance towards TTI risks were analysed qualitatively. Results: Stakeholders' views could be clustered into seven categories: (1) clinical impact; (2) probability of infection; (3) avoidability of infection; (4) cost and health benefits; (5) other consequences of safety measures; (6) non‐consequentialist ethical arguments; and (7) stakeholders' interests. Various arguments were offered that resonate with current ethical thinking about blood safety. Assuming that resources spent on inefficient blood safety measures could be applied more beneficially elsewhere, for example, responders typically expressed tolerance towards TTI risks. Some other arguments seem novel, for instance arguments for risk intolerance based on the low probability of infection and arguments for risk tolerance if patients have a poor prognosis. Conclusion: Understanding the moral experience of stakeholders enriches ethical debate about blood safety and prepares developing more widely acceptable policies. [ABSTRACT FROM AUTHOR]

To avoid risk for allogeneic transfusions in healthy bone marrow (BM) donors, 1–2 preoperative autologous blood donations (PAD) are usually collected before the BM harvest. We analysed the haematological parameters in BM donors before and after the harvest, to assess the efficacy of this practice in limiting the postharvest anaemia. Overall, 102 consecutive donors underwent BM harvest preceded by one (26 cases) or two PAD (76 cases), which were infused during BM collection. We analysed the parameters related to donors, PAD timing and BM graft characteristics. PAD induced a significant decrease in Hb (from 14·6 g/dl, IQ range 13·3–15·5 to12·9 g/dl, IQ range 11·8–13·9; P < 0·0001) in all donors, with a median Hb loss at day −1 of 10·9% (IQ range 6·8–14·2). The PAD‐related Hb decrease was independent of sex or number of PAD, and was inversely related to the time elapsed from first or last PAD. In comparison with values recorded at day‐1, BM harvest produced an additional Hb decrease, accounting for a median Hb loss of 18·9% (IQ range 14·9–24·4). Overall, in comparison with pre‐PAD values, Hb levels at day +1 were reduced of 28·9% (IQ range 23·6–32·2), independently if donors had 1 or 2 PAD reinfused. In conclusion, these data show that two PAD do not carry any advantage over one PAD. An eventual benefit of PAD can be achieved only if an adequate interval between PAD and BM harvest elapses. Prospective randomized studies could be worth to establish if any role for PAD does exist in BM donors. [ABSTRACT FROM AUTHOR]

Objective: Fresh whole blood (WB) has been used in military applications and cardiac surgery. We undertook a study of the coagulation properties of refrigerated WB stored for 21 days and compared them with the properties of reconstituted WB. Study design and methods: Ten WB units were obtained from healthy volunteer donors and stored at 4 ± 2°C. Samples were obtained on Days 1, 2, 4, 6, 8, 10, 14 and 21 from the WB units. Ten units of reconstituted WB were prepared with a ratio of red cells, platelets and plasma of 1:1:1. Tests included complete blood count, electrolyte, routine coagulation, blood coagulation factor and thromboelastography. Results: There was a progressive decline in Hb, WBC, PLT, sodium and coagulation factors but a progressive increase in APTT, PT and potassium in WB. The concentrations of factor (F)V and FVIII as well as FII and FX of WB were higher before Days 4, 2, 8 and 14, respectively, compared with the concentrations of reconstituted WB. The concentrations of FVII, FIX, FXI and FXII in WB were found to be equal to or higher than those in reconstituted WB throughout the course of 21 days. TEG variables in all WB units were normal throughout the course of 10 days. The mean PT and APTT of WB were lower than those of reconstituted WB before Days 14 and 10, respectively. Conclusion: This study suggests that the coagulation properties of refrigerated WB were equal to or superior to those of reconstituted WB for a minimum of 10 days. [ABSTRACT FROM AUTHOR]

Thromboelastography is a technique to evaluate the overall coagulation behaviour of blood and blood components. First, we evaluated the literature concerning the use of thromboelastography for characterizing coagulation behaviour of healthy volunteers, such as blood donors. Overall coagulation is sensitive to gender, most likely caused by the difference in haematocrit and plasma content of male versus female blood. Smaller and less pronounced effects in thromboelastographic response are caused by differences in fibrinogen level or by use of oral contraceptives. Short‐term hypercoagulable effects are observed after smoking or blood donation, while small effects of non‐steroidal anti‐inflammatory drugs on platelets are also present. Second, in whole blood donations, the thromboelastographic variables are also sensitive to storage time and temperature, but are less sensitive to levels of clotting factors. Platelet count and quality have little influence on thromboelastographic variables, and differences are mainly observed at counts <100x109/l, after extended storage time of platelet concentrates or storage under specific conditions, including freezing. Thromboelastographic profiles of plasma samples are mainly affected by residual cell counts, microparticles and fibrinogen levels, and less by levels of clotting factors. Taken together, publications have shown that as an overall clotting test, thromboelastography may support optimization of blood component preparation and storage with regard to temperature, time and secondary and tertiary treatments. Minimal deviations of in vitro quality are most reliable demonstrated when an appropriate assay is chosen. [ABSTRACT FROM AUTHOR]

Background and Objectives: Many consider volunteer blood donors as ideal candidates for unrelated haematopoietic progenitor cell (HPC) donation. However, frequent blood donations could influence the results of HPC mobilization. To our best knowledge, there are no data on the possible impact of repeated blood donation on efficiency of subsequent HPC mobilization by granulocyte colony‐stimulating factor (G‐CSF). Materials and Methods: We compared outcomes of HPC mobilization in unrelated donors with and without a history of blood donation. We conducted a prospective study on 287 consecutive donors admitted to the Department of Hematology since January 2016. The final analysis included 153 donors who agreed to take part in the study and had undergone stem cell mobilization with G‐CSF. Results: History of blood donations prior to haematopoietic stem cell mobilization with G‐CSF does not have a significant impact on the number of collected CD34+ cells in the first leucocytapheresis (516.2 x 106 (170–1148) in blood donors vs 490.5 x 106 (101–1154) in non‐donors) (P = 0.32). In all donors, in this study mobilization of HPC was successful: 87.5% of blood donors and 85.6% of non‐donors collected the required cell number in a single apheresis. In blood donors, a higher number of blood donations within 2 and 5 years prior to HPC mobilization correlated significantly with successful donation within one leucocytapheresis (P = 0.014 and P = 0.024, respectively). Conclusion: Multiple blood donations do not significantly influence the outcome of HPC collection in unrelated donors. Blood donors and non‐donors have similar results of HPC collection, so there is no reason to favour either group. [ABSTRACT FROM AUTHOR]

Background and Objectives: Phlebotomy is a central task for whole blood donation, yet there are no published standards regarding systematic donor vein assessment or the impact of vein quality on successful blood donation. Blood donation failures and related adverse events are highly predictive of donors not returning for future blood donation. A specific blood donation vein scoring tool was assessed to measure donor vein suitability for whole blood collection and investigate the correlation of the donor's veins with donation outcomes. Materials and Methods: The vein assessment tool consisted of three questions using a 5‐point Likert‐type scale to measure responses. Two phlebotomists performed blinded assessments of each donor's veins on each arm using the tool. The individual measures were then aggregated to provide a total vein score out of 12. Inter‐rater reliability of the vein score tool was assessed by calculating the intraclass correlation coefficient for absolute agreement. Results: Fifty‐seven phlebotomists across four fixed blood donation centres performed paired vein assessments on 553 blood donors. The intraclass correlation coefficient indicated moderate inter‐rater reliability was achieved. The median scores for viable donations were 10, for non‐viable donations were 6·5 and for failed phlebotomies were 4. Donation histories of donors with lower vein scores indicated lower success during blood donation. Conclusion: The vein score tool appears to be predictive of a successful donation outcome, however, since there was not a suitably high correlation between the scores of the two assessors, further refinement of the tool will be required prior to wider use. [ABSTRACT FROM AUTHOR]

Background and Objectives: Most men have larger blood volumes and iron stores, making them more suitable blood donors; however, women dominate the donor population in Stockholm. Motives for cessation and returning were examined in a group of lapsing young male donors, in order to improve retention. Methods: Demographic studies of the donor population. An online survey was sent to 1012 lapsing male donors aged 18–35 years. Questions focused on reasons for lapsing, returning and donor motivation. Results: Demographic studies showed a predominance of female donors, especially in younger age groups. Most lapsing male donors were 18–35 years old. In this age group, there was a large turnover of male donors. The most common reason for lapsing was simply falling out of habit despite repeated invitations. Other reasons were lack of time, work, travel, new sex partner and change in residence. Adverse events were of less importance. The majority indicated that they would return for donation if they had more time and/or received yet another invitation. Donors lapsing after a single donation would significantly more often donate again, than repeat donors, if they were given information on the use of their blood. Furthermore, single‐time donors found the time spent donating significantly more important. Conclusions: Increased accessibility and repeated invitations are essential for retention of young male donors. Time constraints are important, suggesting improvements in increased availability as well as shortening of visits. Young men also need help integrating blood donation routines into their life. [ABSTRACT FROM AUTHOR]

Background: In June 2017, Israel lifted the ban on blood donations from men who have sex with men (MSM) and accepts donations if 12 months have passed since the last sexual contact. Recently, the National Blood Services suggested a novel approach that involves acceptance of MSM blood donations without deferral, keeping solely the frozen plasma in quarantine and releasing it for transfusion if a subsequent donation, at least 4 months later, is found negative for transfusion‐transmitted agents. In this study, we examined the attitudes and perceptions of MSM to the new Frozen Plasma Quarantine Policy (FPQP). Method: A survey was published on gay‐oriented websites, collecting anonymous demographic data, history of blood donations and attitudes towards the new policy. Results: We analysed responses from 1233 MSM. Of these, 13·4% had donated blood at least once during the previous year, almost all of them (89·7%) not complying with the current 12‐month deferral. Most respondents (64·5%) supported the suggested new approach and would consider donating blood if it were introduced. Of MSM who had donated blood in the previous year, 85% stated they would agree to reveal their sexual practice in the donor health questionnaire (DHQ) in order to be included in the programme, compared with 8·5% under the current 12‐month deferral policy. Conclusion: The suggested Plasma Quarantine Policy may be more acceptable to MSM than a 12‐month deferral and increase their compliance with the blood services policy. This and retesting of donors may increase blood safety. [ABSTRACT FROM AUTHOR]

Background and objectives: The objective of the present study was to investigate the fear of blood, injections and fainting as barriers to blood donation in a sample of primary healthcare users in a Brazilian municipality. Materials and Methods: This is a cross‐sectional survey of primary care patients in 12 randomly selected healthcare facilities in Ribeirão Preto, Brazil in 2015–2016. Key variables were lifetime blood donation history, intentions to donate blood among non‐donors and current donation practice. To assess fear of blood in general (FBG), fear of injections in general (FIG) and fear of fainting due to fear of injection (FFI), we used the Blood Injection/Fear Scale (BIFS). We tested associations between variables using regression models and conditional inference trees (CIT). Results: A total of 1055 primary healthcare users participated (79·7% female, mean age 40·6 years [SD = 15·2]), 63·4% never donated blood, 13·3% reported they are unable to donate, 6·1% donated only once, 17·2% donated multiple times. Women had higher scores for FIG and FBG. FFI was associated with middle socioeconomic status. Those who never intended to donate exhibited the highest scores in the three dimension of fear. By CIT analysis, being female and high scores for FBG are associated with decreased blood donation. Among males, blood donation frequency is low among those aged 33 years and under. Conclusion: Fear of blood, injections and fainting are barriers to blood donation in Brazil. Efforts to recruit and retain blood donors should convey information on blood donation processes and address misconceptions that may increase fear. [ABSTRACT FROM AUTHOR]

Blood transfusion in sub‐Saharan Africa (SSA) is at a crossroad. Significant recent developments may help meet local needs in safe blood products and fulfil a global health target, as highlighted by the World Health Organization (WHO) Millennium and Sustainable Development Goals, in improving supply and safety, and ensuring the gradual implementation of selective haemotherapy. When WHO recommended the evaluation of convalescent blood or plasma to treat Ebola‐infected patients during the recent epidemics, substantial gaps in local blood collection, testing and technology infrastructure and safety, as compared to best accepted quality standards, became evident. This evidence should now serve as an 'electro‐shock'/awakening call used to highlight the needs for local governments to support National Blood Transfusion Services and establish robust national regulatory authorities that are mandated to bear regulatory responsibilities of blood establishments. A nationally co‐ordinated blood programme is the best tool to gather reliable epidemiological data, address local needs in blood and blood products and serve public health. A literature review using WHO website and PubMed was conducted in this article to outline the current clinical use of blood products and plasma derivatives in SSA. This text also intends to highlight the gaps to be filled in the coming years with respect to quality, safety, supply and efficacy of blood and plasma products, in line with WHO guidelines for transfusion. [ABSTRACT FROM AUTHOR]

The article offers information on the International Forum on the use of prehospital blood and pharmaceuticals in the treatment of traumatic hemorrhage patients. Topics discussed include early intervention with blood products in the prehospital setting; feasibility and success of transfusing whole blood on the battlefield during World War I; and relative safety from an immunohaematological perspective of transfusing uncrossmatched red blood cells.

Background and Objectives: Effective recruitment and retention of male donors are vital for the ongoing provision of blood products. Compared with females, male donors are less likely to be medically deferred or experience vasovagal reactions and are typically preferred for plasmapheresis donation in voluntary non‐remunerated settings. However, females outnumber males among donors aged under 40 years. This systematic review aimed to synthesize evidence and identify key motivators for blood donation among males to inform targeted recruitment/retention campaigns. Materials and Methods: Databases (e.g. EBSCOhost, Web of Science) were searched using terms (dona* OR dono*) AND (blood OR aphaeresis OR apheresis OR plasma* OR platelet* OR platlet*) in title AND (male OR gender OR sex OR female) AND (motivat* OR intention OR attitude OR behavi* OR predictor OR barrier OR deter*) NOT (organ OR sperm OR tissue OR autologous OR oocyte) in text. Two researchers independently systematically scanned quantitative, full‐text, English language, peer‐reviewed publications from 1990 to 2015 that examined males/females separately with outcomes of blood donation or self‐reported intention. Two additional researchers resolved discrepancies. Results: Among 28 identified articles, the most frequently cited motivators for male blood product donation were as follows: altruism; positive attitude towards incentives; health check(s); subjective norms. Altruism was less pronounced among males compared with females and was combined with ‘warm glow’ in novice males (impure altruism). Perceived health benefits and incentives (e.g. coffee mugs) were stronger motivators of males than females. Conclusion: Marketing campaigns for recruitment/retention of male donors should focus on identified motivators rather than take a ‘one‐size‐fits‐all’ approach. [ABSTRACT FROM AUTHOR]

Background and Objectives: The aim of this survey was to evaluate the knowledge about Patient Blood Management (PBM) principles and practices amongst clinicians working in seven European hospitals participating in a European Blood Alliance (EBA) project. Materials and Methods: A web‐based questionnaire was sent to 4952 clinicians working in medical, surgery and anaesthesiology disciplines. The responses were analysed, and the overall results as well as a comparison between hospitals are presented. Results: A total of 788 responses (16%) were obtained. About 24% of respondents were not aware of a correlation between preoperative anaemia (POA) and perioperative morbidity and mortality. For 22%, treatment of POA was unlikely to favourably influence morbidity and mortality even before surgery with expected blood loss. More than half of clinicians did not routinely treat POA. 29%, when asked which is the best way to treat deficiency anaemia preoperatively, answered that they did not have sufficient knowledge and 5% chose to ‘do nothing’. Amongst those who treated POA, 38% proposed red cell transfusion prior to surgery as treatment. Restrictive haemoglobin triggers for red blood cell transfusion, single unit policy and reduction of number and volumes of blood samples for diagnostic purposes were only marginally implemented. Conclusion: Overall, the responses indicated poor knowledge about PBM. Processes to diagnose and treat POA were not generally and homogeneously implemented. This survey should provide further impetus to implement programmes to improve knowledge and practice of PBM. [ABSTRACT FROM AUTHOR]

Background and Objectives Hepatitis E virus ( HEV) is a known transfusion-transmissible agent. HEV infection has increased in prevalence in many developed nations with RNA detection in donors as high as 1 in 600. A high proportion of HEV infections are asymptomatic and therefore not interdicted by donor exclusion criteria. To manage the HEV transfusion-transmission ( TT) risk some developed nations have implemented HEV RNA screening. In Australia, HEV is rarely notified; although locally acquired infections have been reported, and the burden of disease is unknown. The purpose of this study was to determine the frequency of HEV infection in Australian donors and associated TT risk. Materials and Methods Plasma samples ( n = 74 131) were collected from whole blood donors during 2016 and screened for HEV RNA by transcription-mediated amplification ( TMA) in pools of six. Individual TMA reactive samples were confirmed by RT- PCR and, if positive, viral load determined. Prevalence data from the study were used to model the HEV- TT risk. Results One sample in 74 131 (95% CI: 1 in 1 481 781 to 1 in 15 031) was confirmed positive for HEV RNA, with an estimated viral load of 180 IU/ml, which is below that typically associated with TT. Using a transmission-risk model, we estimated the risk of an adverse outcome associated with TT- HEV of approximately 1 in 3·5 million components transfused. Conclusion Hepatitis E virus viremia is rare in Australia and lower than the published RNA prevalence estimates of other developed countries. The risk of TT- HEV adverse outcomes is negligible, and HEV RNA donor screening is not currently indicated. [ABSTRACT FROM AUTHOR]

Almost 150 years after the first autologous blood transfusion was reported, intraoperative blood salvage has become an important method of blood conservation. The primary goal of autologous transfusion is to reduce or avoid allogeneic red blood cell transfusion and the associated risks and costs. Autologous salvaged blood does not result in immunological challenge and its consequences, provides a higher quality red blood cell that has not been subjected to the adverse effects of blood storage, and can be more cost-effective than allogeneic blood when used for carefully selected surgical patients. Cardiac, orthopaedic and vascular surgery procedures with large anticipated blood loss can clearly benefit from the use of cell salvage. There are safety concerns in cases with gross bacterial contamination. There are theoretical safety concerns in obstetrical and cancer surgery; however, careful cell washing as well as leucoreduction filters makes for a safer autologous transfusion in these circumstances. Further studies are needed to determine whether oncologic outcomes are impacted by transfusing salvaged blood during cancer surgery. In this new era of patient blood management, where multimodal methods of reducing dependence on allogeneic blood are becoming commonplace, autologous blood salvage remains a valuable tool for perioperative blood conservation. Future studies will be needed to best determine how and when cell salvage should be utilized along with newer blood conservation measures. [ABSTRACT FROM AUTHOR]

HIV pre-exposure prophylaxis (Pr EP) is the use of one or more antiretroviral medications (in combination) to prevent HIV infection. The most commonly used Pr EP medication (Truvada®, Gilead Sciences, Inc.) acts by inhibiting HIV-1 reverse transcriptase. If someone who is using Pr EP unknowingly becomes HIV infected (termed 'Pr EP breakthrough infection'), there may be suppressed viral replication resulting in a virus level undetectable by the most sensitive HIV NAT. Failure to seroconvert and seroreversion (loss of previously detectable HIV antibodies) have also both been observed with 2nd, 3rd and 4th generation screening immunoassays, as well as Western blot assays. If such a person was tested in the course of donating blood, the results may therefore be difficult to interpret. The index of suspicion for possible Pr EP 'interference' should be highest in the context of concomitant low-level positive or 'greyzone' reactivity on HIV NAT and serological tests, which is an unusual pattern in acutely HIV-infected blood donors. Another possibility is detectable HIV RNA with negative HIV serology (i.e. a potential ' NAT yield' case) but without subsequent HIV seroconversion (or disappearance of HIV RNA). Excluding antiretroviral therapy or Pr EP use by the donor in such circumstances would be important. The current rarity of Pr EP breakthrough infection indicates that any potential safety risk is likely very small. However, considering the increasing use of Pr EP we feel it is prudent for those interpreting HIV donor screening test results to consider the potential for Pr EP interference. [ABSTRACT FROM AUTHOR]

Background and Objectives Donor screening alone cannot eliminate the risk of transfusion-transmitted HIV infection. Donor deferral according to established criteria is a supplemental strategy, which has focused largely on men who have sex with men (MSM). A study was conducted to determine the compliance of non- MSM donors with such criteria and examine its implications on blood safety. Materials and Methods Chinese donors who have just donated blood at blood donor centres in Hong Kong were recruited. Based on the contents of the routinely administered predonation Health Screening Questionnaires, participants were requested to complete a survey to assess their practice of deferrable risk behaviours and lifestyle encounters, using tablet computers. Results Over an 8-week period in mid-2016, 1614 donors (male-to-female ratio 1·23) had enrolled in the survey, accounting for 40% of donors giving blood on the survey days. The proportion of respondents who gave blood despite having deferrable HIV risk was 5%: MSM 1·2% (of the male donors); non- MSM risk behaviours 2·6%; risky lifestyle encounters 2·1%. If inconsistent declaration and suspected risk behaviours were included, the total non-compliance rate became 10·8%. Male donors had a higher prevalence of deferrable behavioural risk, even after excluding MSM. Unawareness and non-acceptability were main reasons for non-compliance. Conclusion The non-compliance rate of donors to deferral was high, although the ultimate infection risk might be small in the presence of universal screening. Simplification of questionnaires, focus on time-limited deferral and a reduction of deferral items may improve the deferral mechanism without compromising blood safety. [ABSTRACT FROM AUTHOR]

Background and objectives Methylene blue is a phenothiazine dye, which in combination with visible light has virucidal and bactericidal properties, disrupting the replication of a broad range of enveloped viruses and some non-enveloped viruses. The study objective was to collect data on adverse reactions occurring with methylene blue plasma administered in a routine clinical practice environment and document their characteristics and severity. Materials and methods This was an open label, multicentre, non-controlled, non-randomized, non-interventional study. Patients who receive a methylene blue plasma transfusion were observed for any signs and symptoms (adverse reactions) within 24 h safter the start of the transfusion, in different hospitals for a study duration of at least 1 year. Results A total of 19 315 methylene blue plasma units were transfused. There were eight patients with adverse reactions recorded during the study, one of them serious. Two had more than one reaction (two and four, respectively). Three patients had previous transfusions with methylene blue plasma only. Conclusion Methylene blue plasma has a very acceptable safety profile with a rate of serious adverse reactions of 0·5/10 000 units. [ABSTRACT FROM AUTHOR]

Background and Objectives The present general plasticizer di-2-ethylhexyl-phthalate in polyvinylchloride ( PVC) blood bags is only physically dispersed in PVC and will therefore leach into blood components. The objective of this study was to perform a first preliminary red blood cell ( RBC) storage evaluation in a new blood bag manufactured of polyolefin without any inclusion of potentially migrating substances. Study Design and Methods This is a RBC storage study for 42 days. Blood collection was performed in a polyolefin-based PVC-free blood bag. RBCs were prepared within 8 h. Two different RBC additive solutions were used, either PAGGS-M or PAGGG-M. We weekly measured pH, K+, glucose, lactate, haemolysis, red cell ATP and 2,3- DPG. Results RBC storage in PAGGS-M resulted in high haemolysis levels already after 21 days, exceeding the European maximum limit of 0·8%, and low ATP levels by the end of the storage period. With PAGGG-M, haemolysis exceeded 0·8% after 28 days of storage. For additional parameters, the results were comparable to those of previous studies in conventional blood bags. Conclusion This is a first preliminary study of RBC storage in a new type of blood bags. PAGGG-M gave encouraging results except for its inability to prevent increased haemolysis. There will be room for further development of RBC additive solutions to address the haemolysis problems. Plasma should also be tested regarding the stability of coagulation and activation pathway variables. There may also be a potential for future use of the bag for preparation of pooled buffy-coat-derived platelets. [ABSTRACT FROM AUTHOR]

Background and objectives Fresh frozen plasma ( FFP) usage has significantly increased over the last decade leading to elevated healthcare costs. Although FFP is used in several clinical settings, it is often inappropriately transfused and evidence for its clinical efficacy is poor. Here, we describe plasma usage and transfusion costs in a real-world US inpatient setting to determine the cost-effectiveness of FFP transfusion and for comparison to various patient blood management ( PBM) options to treat coagulopathies. Materials and methods All activities related to plasma transfusion recorded at a single US hospital over one calendar year were collected in a stepwise manner using an activity-based costing ( ABC) methodology. This model maps all technical, administrative and clinical processes inherent to the cost of plasma. Results Of 18 200 inpatients recorded, 849 were charged for blood products. In total, 136 medical and surgical inpatients were charged for 577 units of FFP, receiving a total of 534 units; 43 units were charged but not transfused. The total cost per unit of FFP transfused was $409·62 and $1,608·37 per patient transfused with FFP. Wasted products, in-hospital processes and overhead costs were found to account for 89·8% of the total cost of FFP transfusions. Conclusion This study is the first to use ABC methodology to determine the full cost of plasma transfusion in a US inpatient setting. These data reveal the true cost of plasma, providing a useful reference point to compare with the cost of other PBM options to manage coagulation disorders. [ABSTRACT FROM AUTHOR]

Background and Objectives Biological raw materials, the basis for cellular therapies such as stem cells, have a significantly greater degree of complexity than their traditional pharmaceutical counterparts. This can be attributed to the inherent variation of its source - human beings. Currently, cell therapies are made in small, ad hoc batches, but larger scale production is a prerequisite to meeting future demand and will require a quality-by-design approach to manufacturing that will be designed around, or be robust to this variation. Quantification of variation will require understanding of the current baseline and stratification of its sources. Materials and Methods Haematopoietic stem cell therapy was chosen as a case study to explore this variation, and a PRISMA-guided (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) systematic meta-analysis was carried out for a number of predetermined cell measurements. Results From this data set, it appears that the extent of variation in therapeutic dose (in terms of transplanted total nucleated cells and CD34+ cells per kilogram) for HSCT is between one and four orders of magnitude of the median. Conclusions This is tolerated under the practice of medicine but would be unmanageable from a biomanufacturing perspective and raises concerns about comparable levels of efficacy and treatment. A number of sources that will contribute towards this variation are also reported, as is the direction of travel for 4 greater clarity of the scale of this challenge. [ABSTRACT FROM AUTHOR]

The article presents abstracts on progress in developing countries including a comprehensive blood service to England and North Wales, a research in blood services in Africa, and a review of blood services research capacity in Zimbabwe.

Background and Objectives In this study, we compare variant Creutzfeldt- Jakob disease (v CJD) cases definitely linked to blood transfusion, those with a history of blood transfusion in which no donor has developed v CJD and primary cases with no history of blood transfusion. The aim is to determine whether there are any differences in the demographics or clinical phenotype in these groups that might suggest additional cases of transfusion transmission of v CJD. Materials and Methods All cases of v CJD who are old enough to donate blood (i.e. >17 years old) are notified to the UKBTS at diagnosis, regardless of whether they are known to have a blood donation history. A search is then made for donor records and, if found, all components produced and issued to hospitals are identified and their fate determined. Recipient details are then checked against the NCJDRSU register to establish whether there is a match between these individuals and patients who have been diagnosed with v CJD. In the reverse study, attempts are made to trace the donors to all cases reported to have received a blood transfusion and donors' details are checked against the register to determine if any have developed v CJD. Results Of the 177 cases of v CJD diagnosed in the UK as of 1 February 2014, the TMER study identified 15 cases reported to have received a blood transfusion. Transfusion records were unavailable for 4 of these cases, all pre-1980, and in one other case there was no transfusion recorded in the medical notes. Transfusion records were found for 10 cases. One case transfused at symptom onset was excluded from this analysis. The mean age at onset of symptoms of the remaining nine transfusion recipients (four female and five male) was 42·9 years; 57·6 years in the three known transfusion-transmitted cases and 35·5 years in the six not linked cases. In one of these cases, details of components transfused were unavailable, and the remaining five cases received a total of 116 donor exposures with 112 donors identified, none of whom is known to have developed clinical v CJD. To date, five of the 112 identified donors have died and none was certified as dying of v CJD or any other neurological disorder. Two of the transfusion-transmitted cases did not fulfil diagnostic criteria for probable v CJD during life but were confirmed at post-mortem. Both cases were in the older age range (68 and 74 years, respectively), and neither had a positive MRI brain scan. The remaining cases all fulfilled the criteria for the diagnosis of v CJD in life, but two of these had atypical features and were older than the expected age at onset for v CJD. Conclusion In conclusion, it is possible that one or more of the v CJD cases that received a blood transfusion derived from an individual not known to have v CJD were infected by the blood transfusion. However, the evidence for this is weak, and the absence of a past history of transfusion in most cases of v CJD excludes a large number of unrecognised transfusion-transmitted cases. [ABSTRACT FROM AUTHOR]