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Background Methods Results Conclusion China's significant population affected by HIV poses a substantial threat to blood transfusion safety. Despite advancements in blood testing techniques, a residual risk of HIV transmission persists. Accurately assessing HIV epidemic and the residual risk is vital for monitoring blood supply safety and evaluating the effectiveness of new screening tests.We conducted a retrospective analysis of HIV detection results among voluntary blood donors from 2003 to 2022. The study included data on HIV‐confirmed positive donors, HIV prevalence, infection risk factors, and an incidence‐window period mathematical model to estimate the residual risk of HIV.Between 2003 and 2022, HIV prevalence among blood donors in Guangzhou showed a peak‐shaped trend, initially increasing before declining. The overall HIV prevalence was 18.9 infections per 100,000 donations. Male donors had a significantly higher prevalence compared with female donors. Donors aged 26–35 years had the highest prevalence. Ethnic minority donors had a higher prevalence compared with Han donors. Repeat donors had a lower prevalence compared with first‐time donors. Donors from other provinces had a higher prevalence compared with local donors. During the period of 2003 to 2022, the residual risk of HIV in Guangzhou steadily decreased, reaching a notable 1 in 526,316 donations in the past two years.The HIV epidemic among blood donors in Guangzhou remains severe, but the residual risk of HIV is decreasing. Novel detection methods have proven advantageous in reducing this residual risk. Implementing additional effective measures is imperative to ensure blood safety and curb the spread of HIV. [ABSTRACT FROM AUTHOR]

Background Materials and Methods Results Discussion Hepatitis B core antibody (anti‐HBc) screening has been implemented in many blood establishments to help prevent transmission of hepatitis B virus (HBV), including from donors with occult HBV infection (OBI). We review HBV screening algorithms across blood establishments globally and their potential effectiveness in reducing transmission risk.A questionnaire on HBV screening and follow‐up strategies was distributed to members of the International Society of Blood Transfusion working party on transfusion‐transmitted infectious diseases. Screening data from 2022 were assimilated and analyzed.A total of 30 unique responses were received from 25 countries. Sixteen respondents screened all donations for anti‐HBc, with 14 also screening all donations for HBV DNA. Anti‐HBc prevalence was 0.42% in all blood donors and 1.19% in new donors in low‐endemic countries; however, only 44% of respondents performed additional anti‐HBc testing to exclude false reactivity. 0.68% of anti‐HBc positive, HBsAg‐negative donors had detectable HBV DNA. Ten respondents did universal HBV DNA screening without anti‐HBc, whereas four respondents did not screen for either. Deferral strategies for anti‐HBc positive donors were highly variable. One transfusion‐transmission from an anti‐HBc negative donor was reported.Anti‐HBc screening identifies donors with OBI but also results in the unnecessary deferral of a significant number of donors with resolved HBV infection and donors with false‐reactive anti‐HBc results. Whilst confirmation of anti‐HBc results could be improved to reduce donor deferral, transmission risks associated with anti‐HBc negative OBI donors must be considered. In high‐endemic areas, highly sensitive HBV DNA testing is required to identify infectious donors. [ABSTRACT FROM AUTHOR]

Background: Long COVID is a common condition lacking consensus definition; determinants remain incompletely understood. Characterizing immune profiles associated with long COVID could support the development of preventive and therapeutic strategies. Methods: We used a survey to investigate blood donors' infection/vaccination history and acute/persistent symptoms following COVID‐19. The prevalence of long COVID was evaluated using self‐report and an adapted definition from the RECOVER study. We evaluated factors associated with long COVID, focusing on anti‐spike and anti‐nucleocapsid SARS‐CoV‐2 antibodies. Lastly, we investigated long COVID clinical subphenotypes using hierarchical clustering. Results: Of 33,610 participants, 16,003 (48%) reported having had COVID‐19; 1853 (12%) had self‐reported long COVID, 685 (4%) met an adapted RECOVER definition, and 2050 (13%) met at least one definition. Higher anti‐nucleocapsid levels measured 12–24 weeks post‐infection were associated with higher risk of self‐reported and RECOVER long COVID. Higher anti‐spike IgG levels measured 12–24 weeks post‐infection were associated with lower risk of self‐reported long COVID. Higher total anti‐spike measured 24–48 weeks post‐infection was associated with lower risk of RECOVER long COVID. Cluster analysis identified four clinical subphenotypes; patterns included neurological and psychiatric for cluster 1; neurological and respiratory for cluster 2; multi‐systemic for cluster 3; and neurological for cluster 4. Discussion: Long COVID prevalence in blood donors varies depending on the adopted definition. Anti‐SARS‐CoV‐2 antibodies were time‐dependently associated with long COVID; higher anti‐nucleocapsid levels were associated with higher risk; and higher anti‐spike levels were associated with lower risk of long COVID. Different underlying pathophysiologic mechanisms may be associated with distinct clinical subphenotypes. [ABSTRACT FROM AUTHOR]

Background: In December 2021, the U.S. Food and Drug Administration published a letter to clinical laboratory staff and healthcare providers detailing a risk of false Rapid Plasma Reagin (RPR) when using the Bio‐Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit in people who had received COVID‐19 vaccination; Treponema pallidum particle agglutination assays did not appear to be impacted by this issue. We evaluated reactivity rates of syphilis screening with negative confirmatory testing at our institution by year and seasonality. Methods: We performed a retrospective study of routine syphilis testing of whole blood (WB) collections at an academic hospital‐based donor center in the eastern United States. All WB donations from 2011 to 2023 which demonstrated reactive syphilis screening (Beckman Coulter PK TP Microhemagglutination) with negative confirmatory testing (CAPTIA Syphilis (T. pallidum)‐G) were evaluated. Reactivity rates by year and season of donation were compared using unpaired t‐tests. Results: A total of 109 WB donations from 86 unique donors who donated from 2011 to 2023 screened reactive for syphilis with negative confirmatory testing. The unconfirmed syphilis reactivity rate increased from 2018 to 2023 (mean: 0.360%) compared to 2011–2017 (mean: 0.071%, p <.05). An autumnal peak in unconfirmed reactives was observed. Conclusion: The unconfirmed syphilis reactivity rate among WB donors at our institution increased markedly since 2017 compared to the 7 years prior and doubled from 2020 to 2021. No testing assay changes explain these results. The autumnal peak in unconfirmed reactives suggests a possible environmental trigger such as viral infection or vaccination. [ABSTRACT FROM AUTHOR]

Background: The Golden Hour Box (GHB), an iceless blood container designed for transfusion closest to the point of injury, is used by military medical teams in remote damage control resuscitation. While its performance is well‐established in hot environments, it remains underexplored in cold conditions, a significant consideration in emerging global conflict zones. Study Design and Methods: Four GHBs were preconditioned at +4°C or +18°C for 8 h and subsequently exposed to controlled laboratory simulated temperatures of −5, −15, and −25°C for 100 h. The study focused on their capability to maintain an internal temperature between +2 and +6°C, the recommended range for red blood cells unit storage and transport, using calibrated sensors for precise monitoring. Results: When exposed to negative Celsius temperatures, GHBs showed varied performance depending on preconditioning temperatures. When preconditioned at +4°C, GHBs maintained an internal temperature within the target range (+2 to +6°C) for 100 h at −5°C, 52 ± 1 h at −15°C, and 29 ± 4 h at −25°C. In contrast, the internal temperature of GHBs preconditioned at +18°C exceeded this range in less than 30 min, then dropped below 2°C more rapidly than those preconditioned at +4°C, occurring within 20 ± 2 h at −15 and 13 ± 1 h at −25°C. Conclusion: The GHB, when properly preconditioned, effectively maintains internal temperatures suitable for blood product transport in extreme cold. Future research, including analyses of blood performances, is still needed to validate these results in more realistic operational conditions for use in cold environments. [ABSTRACT FROM AUTHOR]

Background: In many countries, sexually active gay, bisexual and other men who have sex with men (gbMSM) continue to be screened based on their sex or gender and the sex or gender of their sexual partner. However, there is growing support that screening based on specific sexual behaviors that pose risk of transfusion transmissible infection is a better approach to donor screening. Study Design and Methods: This paper reports results from Phase 1 (qualitative) of a mixed‐methods study on Canadian blood and plasma donors' views on expanding eligibility for gbMSM by changing to sexual behavior‐based screening. Semistructured interview data with 40 donors (whole blood = 20, plasma = 20; male = 21, female = 18, nonbinary = 1; mean age = 46.2; 10% participation rate) in Canada were analyzed using a thematic approach. Results: All participants, except one, supported the change as they anticipated that at least one of three outcomes would be achieved: increasing blood supply, enhancing equity, and improving or maintaining the safety of blood supply. One donor who was more skeptical of the change questioned the scientific evidence for the change and indicated mistrust of state institutions. The discussion considers implications for blood operators' communication strategies that can be used to reduce donor discomfort with the changes to donor screening. Conclusion: In a nonrandom, purposive sample of 40 Canadian blood and plasma donors, most participants held favorable views regarding expanding the eligibility of gbMSM donors based on sexual risk behavior. Understanding donors' views on increasing eligibility may inform Canadian Blood Services and other blood operators as they develop their communications plans. [ABSTRACT FROM AUTHOR]

Background: The rapid provision of blood products is life‐saving for patients with massive hemorrhage. Ideally, RhD‐negative blood products would be supplied to a woman of childbearing potential whose Rh type is unknown due to the risk of D‐alloimmunization and the potential for hemolytic disease of the fetus and newborn to occur if RhD‐positive blood products are transfused. Therefore, there is a need for a test that rapidly determines her RhD type. This study compared the RhD type determined using a rapid ABO and RhD test to the RhD type determined by an immunohematology reference laboratory. Methods: After receiving ethics review board approval, 200 random, unique, deidentified patient samples that had undergone routine pretransfusion testing in an immunohematology reference laboratory using column agglutination technology were collected and tested using a rapid ABO and RhD test (Eldoncard Home kit 2511). The RhD typing results from these two methods were compared to determine the accuracy of the rapid ABO and RhD test. Results: The rapid ABO and RhD test produced results that were concordant with the transfusion service's results in 199/200 (99.5%) of cases, with a negative predictive value of 98.2% and 99.3% sensitivity. The single outlier was likely an RhD variant due to its serological characteristics. Discussion: These data indicate that this rapid ABO and RhD test could be used for the rapid determination of a patient's RhD type, perhaps even in the emergency department, which could guide the selection of blood products provided during their resuscitation. [ABSTRACT FROM AUTHOR]

Background: Demand for low‐titer Group O whole blood (LTOWB) is increasing for trauma. The whole blood (WB) platelet‐sparing (WB‐SP) filter enables leukoreduction (LR) while retaining platelet quantity and function; however, in the United States WB must be filtered and placed in the cold within 8 h of collection. A longer processing window would facilitate improved logistics and supply of LR‐WB to meet the growing medical need. This study evaluated the impact of increasing filtration timing from <8 h to <12 h on the quality of LR‐WB. Study Design and Methods: Thirty WB units were collected from healthy donors. Control units were filtered within 8 h and test units within 12 h of collection. WB was tested throughout 21 days of storage. Hemolysis, WBC content, component recovery, and 25 additional markers of WB quality were tested including hematologic and metabolic markers, RBC morphology, aggregometry, thromboelastography, and p‐selectin. Results: There were 0 failures for residual WBC content, hemolysis, or pH, and no differences in component recovery between arms. Few differences in metabolic parameters were observed, but the small effect size suggests these are not clinically significant. Trends throughout storage were similar and filtration timing did not impact hematological parameters, platelet activation and aggregation, or hemostatic capacity. Conclusion: Our studies showed that extending filtration timing from 8 to 12 h from the collection does not significantly impact the quality of LR‐WB. Characterization of the platelets demonstrated that storage lesions were not exacerbated. Extending the time from collection to filtration will improve LTOWB inventory in the United States. [ABSTRACT FROM AUTHOR]

Background: Sickle cell trait (SCT) testing of red blood cell (RBC) units is sometimes performed to identify and divert units containing hemoglobin S (HbS). Recipients strategically guarded against this exposure include fetuses, neonates, and children with sickle cell disease (SCD). The clinical necessity of this practice is unclear. Study Design and Methods: A one‐year audit (2018) was performed at a pediatric tertiary care hospital that tests for SCT in RBC units prescribed to children with SCD and neonates. The impact of incorporating varying numbers of SCT RBC units in a single‐unit top‐up, partial‐manual red cell exchange, and automated erythrocytapheresis was modeled in four typical‐parameter age scenarios (2, 5, 10, and 18 years) sharing a high baseline HbS. Additionally, a survey assessing SCT testing practices was administered to Canadian pediatric hospital transfusion laboratories serving hemoglobinopathy programs. Results: Of 2268 donor RBC units tested, one was positive for SCT (0.04% [95% CI: 0.01%–0.24%]), at a cost of $19,384.56 CAD. The impact of SCT unit incorporation on lost HbS reduction was modest (Δ1%–3% [automated erythrocytapheresis] and Δ4%–15% [top‐up/partial manual exchange]). The survey (with all 13 sites responding) showed variable SCT testing practice; four (31%) do not test, four (31%) test for children with SCD, and six (46%) test for neonates. Conclusion: RBC SCT testing may be more costly than beneficial or necessary in children with SCD. As of 2019, our transfusion service has ceased SCT testing for this population. Further research in the fetal/neonatal populations is needed to overturn this entrenched practice. [ABSTRACT FROM AUTHOR]

Background: Genomic testing is already used by blood collection agencies (BCAs) to identify rare blood types and ensure the best possible matching of blood. With ongoing technological developments, broader applications, such as the identification of genetic markers relevant to blood donor health, will become feasible. However, the perspectives of blood donors (and potential blood donors) on routine genomic testing of donor blood are under‐researched. Study Design and Methods: Eight online Focus Groups were conducted: four with donors and four with non‐donors. Participants were presented with three hypothetical scenarios about the current and possible future applications of genomic testing: Performing rare blood type testing; identifying donors with genetic markers associated with iron metabolism; and identifying donors with genetic markers associated with bowel cancer. Results: Testing to identify rare blood types was perceived to be an appropriate application for the BCA to undertake, while identifying markers associated with iron metabolism and cancer genetic markers were only partially supported. Participants raised concerns about the boundaries of acceptable testing and the implications of testing for privacy, data security, and health insurance. Perspectives of donors and non‐donors on all scenarios were similar. Discussion: The principles of who benefits from genomic testing and the perceived role of BCAs were key in shaping participants' perspectives. Participants generally agreed that testing should be directly related to blood donation or be of benefit to the recipient or donor. Findings indicate that consent and communication are key to the acceptability of current and expanded genomic testing. [ABSTRACT FROM AUTHOR]

The document provides a schedule of oral abstract presentations for the Transfusion journal conference. The presentations cover a range of topics including infectious diseases, viruses, storage lesion, blood donor issues, immunohematology, COVID, blood safety evaluation, blood donor testing, donor adverse events, extended blood storage, pediatrics, patient blood management, platelet storage, transfusion medicine service operations, pathogen reduction, clinical transfusion medicine, biotherapy spotlight, assessing blood donor risks, mouse models, and genomics. The presentations will take place at the George R. Brown Convention Center on October 19-22, 2024. [Extracted from the article]

Background: On-site deferral for low hemoglobin (Hb) is common in most countries and deferral rates commonly vary between 1% and 20%. Blood banks continuously strive to reduce deferral rates as these imply an immediate loss of products, a waste of materials, a waste of staff and donor time, and potential loss of donors. Despite many efforts, the main cause of donor deferral-the variability in hemoglobin measurement outcomes-remains largely unaddressed.Study Design and Methods: Repeated hemoglobin measurements obtained at donor intake were used to estimate the variability in measurement outcomes (measurement variability). This information is incorporated in a new algorithm for donor deferral where the mean hemoglobin level of a donor is used to determine both donor eligibility and the deviance of individual measurement outcomes. The algorithm was tested on a cohort of new Dutch donors that started between 2012 and 2022 to evaluate its impact on the donor deferral rate.Results: Historical data from 439,376 new donors with a deferral rate of 5.3% were analyzed by applying the new donor deferral algorithm. It was found that 92% of all deferrals were unnecessary as Hb levels were within the range of expected measurement variability. Contrarily, it appeared that 460 donors (0.10%) made 704 donations (0.06%) whilst not complying with donor eligibility criteria.Discussion: Not accounting for measurement variability can be shown to not only result in unnecessary on-site deferrals but also results in donations by donors that can be shown not to comply with the legally required minimum Hb levels. [ABSTRACT FROM AUTHOR]

Background: Babesia is an intraerythrocytic parasite responsible for hundreds of cases of transfusion‐transmitted babesiosis in the past 50 years. In May of 2020, blood testing for Babesia was implemented at the American Red Cross (ARC) for all donations in endemic areas of the northeastern and midwestern regions of the United States. Methods: Between May 2020 and May 2021, 1,816,669 donations from 13 states and DC were tested for Babesia by the ARC. Testing was performed in pools of 16 whole blood lysates using a licensed nucleic acid test (NAT) targeting Babesia 18S rRNA. Reactive donations were tested for B. microti antibody by immunoglobulin G immunofluorescence. Suspected cases of transfusion‐transmitted babesiosis (TTB) were investigated if reported. Results: The first 13 months of Babesia screening identified 365 NAT‐reactive donations. Antibodies for B. microti were detected in 79% (287) of reactive donations; negative serology samples were prevalent between May and July. Follow‐up donations were collected from 142 donors, and 86% (122), collected up to 74 days after index, remained NAT reactive. Reactive donations were mainly collected in MA (77), CT (68), NY (49), NJ (47), and PA (44), but were identified in all states except Delaware. Most reactive blood donors were male (65%) aged between 40 and 80 years. Since the beginning of Babesia testing, no case of TTB was identified. Conclusions: The absence of TTB cases since implementation of Babesia screening for blood donations collected in endemic areas suggests testing is an effective strategy to eliminate TTB. [ABSTRACT FROM AUTHOR]

Background: Many blood collection agencies are generating important data on donor health outcomes using large‐scale blood donor cohort studies. Such studies can be very effective when donors provide access to linkage of their data to external health databases, and storage and genomic testing of their blood sample. In this study, we aimed to assess the willingness of Australian blood donors to provide additional data and blood sample for donation‐related and other health research. Study design and methods: We invited 2017 donors to complete a survey using four methods (postal letter, postal letter and email, email only, and in‐center recruitment). The survey asked for information on demographics, lifestyle behaviors, health, experience and attitude to blood donation, and willingness to give blood sample and additional data for research. Results: Response rates ranged from 23.8% for email only to 77.2% for in‐center recruitment. Of those who responded (n = 827), 95.5% indicated they would be willing to provide a blood sample for donation and transfusion‐related research. Of these, >90.0% were willing for their sample to be used in research involving genetic testing and other health‐related topics. Also, >90.0% were willing to consent for linkage of their information to external health databases. Conclusions: Donors surveyed reported a high willingness to participate in health research by completing surveys, allowing linkage to external datasets, and providing a blood sample. These findings provide strong support for future longitudinal research studies with Australian blood donors. [ABSTRACT FROM AUTHOR]

Background: Convalescent plasma is undergoing randomized trials as a potential therapeutic option for COVID‐19 infection. Little empirical evidence exists regarding the determination of donor eligibility and experiences with donor selection. Study Design and Methods: This prospective study was conducted at a tertiary care hospital in New York to select plasma donors for a randomized, double‐blind, controlled convalescent plasma trial. Clearance for donation required successful completion of an online questionnaire and an in‐person screening visit, which included (a) completion of a Donor Health Questionnaire (DHQ), (b) Immunoglobulin G (IgG) antibody testing using an immunochromatographic anti‐ severe acute respiratory coronavirus 2 (SARS‐CoV‐2) test, (c) Polymerase chain reaction (PCR) testing if <28 days from symptom resolution, and (d) routine blood bank testing. Results: After receiving 3093 online questionnaires, 521 individuals presented for in‐person screening visits, with 40.1% (n = 209) fully qualifying. Subjects (n = 312) failed to progress due to the following reasons: disqualifying answer from DHQ (n = 30, 9.6%), insufficient antibodies (n = 198, 63.5%), persistent positive PCR tests (n = 14, 4.5%), and blood donation testing labs (n = 70, 22.4%). Importantly, 24.6% and 11.1% of potential donors who reported having PCR‐diagnosed infection had low or undetectable SARS‐CoV‐2 antibody levels, respectively. Surprisingly, 62.9% (56/89) of subjects had positive PCR tests 14–27 days after symptom resolution, with 13 individuals continuing to be PCR positive after 27 days. Conclusion: It is feasible for a single site to fully qualify a large number of convalescent plasma donors in a short period of time. Among otherwise qualified convalescent plasma donors, we found high rates of low or undetectable antibody levels and many individuals with persistently positive PCR tests. [ABSTRACT FROM AUTHOR]

Background: This study compared the likelihood of return to donate and donation rate ratio by age of donors at their first donation when followed up to 12 years. Study Design and Methods: Donation history of two cohorts of first‐time donors (those donating in 2007 and 2013) was extracted until March 2019 from Australian Red Cross Lifeblood's national database. Poisson regression analyses compared donor return and negative‐binomial regression estimated the rate ratio of donations. Results: A total of 120 469 and 95 381 donors were included in the 2007 and 2013 cohorts, respectively. Compared to donors aged 20‐24 years, the likelihood of return in both cohorts increased consistently as age at first donation increased from 30‐years and above. Average number of whole‐blood and plasmapheresis donations increased as the age at first donation increased from 30‐years onward. The whole‐blood donation rate was highest for donors ≥60 years, while plasmapheresis donation rate was highest for donors aged 50‐59 years. These patterns were largely consistent when stratified by sex. Conclusions: To continuously ensure the short‐ to mid‐term sufficiency of blood supply in Australia, targeted recruitment of donors aged 30‐years and above may be considered, however its feasibility and impact should be explored further given relatively smaller proportion of new donors are middle‐aged and older under current policies. Future studies with a longer follow‐up period are needed to examine whether the frequency of donation among those who start donating at a younger age increases later in their life when they are 30‐years or over. [ABSTRACT FROM AUTHOR]

Background: The frequency of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNAemia in blood donors is uncertain. Thus, assays for SARS-CoV-2 RNA detection in blood, validated on commercially available polymerase chain reaction (PCR) systems, are required to allow a good comparability of data.Study Design and Methods: The cobas SARS-CoV-2 dual-target reverse transcriptase PCR (RT-PCR) assay, licensed for respiratory swab SARS-CoV-2 RNA testing, was validated for detection of viral RNA in blood. For the validation panel, SARS-CoV-2-positive plasma samples were prepared by spiking SARS-CoV-2-positive respiratory specimens in negative human plasma. The 95% limit of detection (LOD95) was determined by probit analysis. For clinical validation, coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) donors and patients with COVID-19 with a severe disease course treated in an intensive care unit (ICU) were included.Results: The validation of the SARS-CoV-2 RT-PCR assay for blood demonstrated high sensitivity and specificity and intra- and inter-assay precision and efficiency. The LOD95 for SARS-CoV-2 RNA was 5.0 genome copies/mL (95% confidence interval [CI], 3.3-12 copies/mL) for target 1 and 4.3 genome copies/mL (95% CI, 2.9-10 copies/mL) for target 2. In a cohort of 39 CCP donors with 66 CCP donations no SARS-CoV-2 RNA in plasma was detected. Screening of 25 blood samples of 19 ICU patients with COVID-19 showed six positive results for SARS-CoV-2 RNA in at least one target of the assay.Conclusion: The SARS-CoV-2 RNA assay, only licensed for respiratory swabs, performed on a PCR system for high-throughput testing, showed a good assay performance for blood testing. [ABSTRACT FROM AUTHOR]

The quantification of the coagulopathic state associated with oncologic and hematologic diseases is imperfectly assessed by common coagulation tests such as prothrombin time, activated partial thromboplastin time, fibrinogen levels, and platelet count. These tests provide a static representation of a component of hemostatic integrity, presenting an incomplete picture of coagulation in these patients. Viscoelastic tests (VETs), such as rotational thromboelastometry (ROTEM) and thromboelastography (TEG), as whole blood analyses, provide data related to the cumulative effects of blood components and all stages of the coagulation and fibrinolytic processes. The utility of VETs has been demonstrated since the late 1960s in guiding blood component therapy for patients undergoing liver transplantation. Since then, the scope of viscoelastic testing has expanded to become routinely used for cardiac surgery, obstetrics, and trauma. In the past decade, VETs' expanded usage has been most significant in trauma resuscitation. However, use of VETs for patients with malignancy-associated coagulopathy (MAC) and hematologic malignancies is increasing. For the purposes of this narrative review, we discuss the similarities between trauma-induced coagulopathy (TIC) and MAC. These similarities center on the thrombomodulin-thrombin complex as it switches between the thrombin-activatable fibrinolysis inhibitor coagulation pathway and activating the protein C anticoagulation pathway. This produces a spectrum of coagulopathy and fibrinolytic alterations ranging from shutdown to hyperfibrinolysis that are common to TIC, MAC, and hematologic malignancies. There is expanding literature regarding the utility of TEG and ROTEM to describe the hemostatic integrity of patients with oncologic and hematologic conditions, which we review here. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic caused downtrends in both blood collections and blood usage. Rapidly visualizing the impact of the pandemic and newly implemented hospital policies on usage could potentially inform blood ordering practices to help avoid wastage.Study Design and Methods: Blood usage data were obtained from the laboratory information system. An R-based workflow was written in R Markdown for analysis and visualization. Reports were generated daily and shared with blood bank leadership. Selected reports were shared with institutional leadership, other departments, and collaborating blood suppliers.Results: Mean daily transfusions dropped 42% from 3/9-13 to 3/16-20, with a significant decrease in usage of red cells, plasma, and cryoprecipitate. The greatest decline in use was seen in the general operating rooms, whereas outpatient transfusions remained steady. Weekly total blood usage decreased through the end of March into April and returned to normal levels in May.Conclusion: During two 5-weekday periods of changing hospital policies, overall blood usage decreased by almost half. Visualization of usage by hospital location showed a large decrease in general operating room usage after cancellation of elective procedures. This data visualization has informed decisions to modify standing product orders during an initial period of decreased usage as well as return to normal orders in later months. [ABSTRACT FROM AUTHOR]

Background: An increased risk of complications, including death, has been associated with stored red blood cell (RBC) units in observational studies but not in randomized trials. We aimed to evaluate for volume-dependent effects attributable to length of RBC storage in a secondary analysis of the Age of Blood Evaluation (ABLE) trial.Study Design and Methods: In the 2510 critically ill adults from the ABLE trial randomized to receive RBC units stored not more than 7 days or the oldest compatible RBC units, we estimated the hazard ratio (HR) for death by intensive care unit (ICU) and hospital discharge and by days 28, 90, and 180, within subgroups defined by the number of RBC units received. Extended Cox proportional hazards regression was used to model the HR.Results: A volume-dependent effect of storage age on survival was present for death by 90 and 180 days, but not earlier endpoints. The HR for death by 90 days was 0.55 (95% confidence interval [CI], 0.11-0.98, fresh vs standard) after transfusion of 6 RBC units but 1.45 (95% CI, 1.06-1.98) after transfusion of 1 RBC unit.Conclusion: In this exploratory analysis, volume-dependent effects related to RBC storage were documented in the ABLE trial. The harms associated with small volumes of fresh RBC units and large volumes of older RBC units should be further explored. [ABSTRACT FROM AUTHOR]

Background: Risk of transfusion-transmitted (TT) malaria is mainly associated with whole blood (WB) or red blood cell (RBC) transfusion. Risk mitigation relies mostly on donor deferral while a limited number of countries perform blood testing, both negatively impacting blood availability. This study investigated the efficacy of the pathogen reduction system using amustaline and glutathione (GSH) to inactivate Plasmodium falciparum in WB.Study Design and Methods: WB units were spiked with ring stage P. falciparum infected RBCs. Parasite loads were measured in samples at time of infection, after 24 hours at room temperature (RT), and after a 24-hour incubation at RT post-treatment with 0.2 mM amustaline and 2 mM GSH. Serial 10-fold dilutions of the samples were inoculated to RBC cultures and maintained up to 4 weeks. Parasitemia was quantified by cytometry.Results: The P. falciparum viability assay has a limit of detection of a single live parasite per sample. Input parasite titer was >5.7 log10 TCID50 per mL. A 24-hour incubation at RT paused parasite development in controls, but they retained viability and infectivity when tested in culture. In contrast, no infectious parasites were detected in the amustaline/GSH-treated sample after 4 weeks of culture.Conclusion: A robust level of P. falciparum inactivation was achieved in WB using amustaline/GSH treatment. Parasite log reduction was >5.7 log10 TCID50 per mL. Development of such a pathogen reduction system may provide an opportunity to reduce the risk of TT malaria and improve blood availability. [ABSTRACT FROM AUTHOR]

Background: The Transfusion Register of Irregular Antibodies and Cross-match Problems (TRIX) is a unique national database in the Netherlands that was launched in 2007. Transfusion laboratories register the presence of irregular RBC alloantibodies for their patients and can consult the database for information that is relevant for pretransfusion testing, unknown in their own laboratory information system.Study Design and Methods: Data from the TRIX database 10 years after implementation have been analyzed to demonstrate the added value of TRIX for transfusion practice. TRIX antibody registration, antibody disappearance likelihood, and differences between men and women have been analyzed and evaluated.Results: In the 10-year period 2007 to 2016, a total of 80,164 alloantibodies have been identified and registered in 62,110 individuals. Of the antibodies, 81% were reported in women and 19% in men (female:male, 4.3:1). Rh (DCcEe and Cw ), K, Fya , and Jka antibodies account for 65.6% of all antibody registrations. M and Lewis antibodies account for 18.6% of all antibodies. Antibody disappearance likelihood is relatively high for the clinically relevant antibodies directed against Jkb , s, Fyb , and e. Antibodies directed against D, Fya , and K have a relatively low antibody disappearance likelihood.Conclusion: TRIX is a unique and useful tool for transfusion laboratories for timely and up-to-date information on the presence of erythrocyte antibodies, which improves pretransfusion testing and compatible blood selection. TRIX also provides macro data on the prevalence of individual antibodies and antibody disappearance likelihoods that can be used for developing blood type matching strategies for patient groups at risk. © 2019 AABB. [ABSTRACT FROM AUTHOR]

Background: CD47 is a novel therapeutic target in the treatment of solid-organ and hematologic malignancies. CD47 is also expressed on RBCs. Here, we report our experience of the RBC effects and the impact on blood bank testing and transfusion management in a Phase 1 trial of the humanized anti-CD47 monoclonal antibody Hu5F9-G4 in relapsed or primary refractory acute myeloid leukemia (AML) (NCT02678338).Study Design and Methods: Nineteen patients with relapsed or primary refractory AML treated across five UK centers were included for analysis. Patients received escalating doses of Hu5F9-G4. Serial laboratory data were collected to evaluate impact on hemoglobin (Hb), markers of hemolysis (bilirubin, lactate dehydrogenase, reticulocyte count), transfusion requirements, and blood compatibility testing.Results: A decline in Hb was observed with drug administration (median Hb change, -1.0 g/dL; range, 0.4-1.6) with associated increase in transfusion requirements. Patients responded to transfusion with a median Hb increment per unit of 1.0 g/dL. RBC agglutination was seen in all cases without associated change in Hb, lactate dehydrogenase, bilirubin, or reticulocyte count. Nine of 19 (47%) patients developed a newly positive antibody screen with a pan-agglutinin identified in plasma. Invalid ABO blood grouping occurred in 4 of 12 (33%) non-group O patients due to anomalous reactivity in the reverse ABO-type results.Conclusions: Treatment with Hu5F9-G4 in patients with AML resulted in an Hb decline and increased transfusion requirements. Problems with ABO blood typing and compatibility testing were widely observed and should be expected by centers treating recipients of Hu5F9-G4. [ABSTRACT FROM AUTHOR]

Background: Parvovirus B19 (B19V) can cause severe anemia, hydrops foetalis, and even death in vulnerable patients. To prevent transfusion-transmitted B19V infection of at-risk patients, B19V antibody screening of blood donors was implemented. The cost-effectiveness of this intervention is unclear, as the likelihood of transmission through blood and subsequent complications for recipients are unknown. This study estimates the cost-effectiveness of anti-B19V donor screening in the Netherlands.Study Design and Methods: The estimates needed for the cost-effectiveness model were: the occurrence of B19V in Dutch blood donors, the number of anti-B19V tested products required by hospitals, the likelihood of morbidity and mortality given B19V infection, treatment costs, and screening costs. These estimates were obtained from literature and observational data. When data were unavailable, structured expert judgment elicitation and statistical modeling were applied.Results: The costs of preventing one transfusion transmitted B19V infection are estimated at €68,942 (€42,045 - €102,080). On average, 1.25 cases of morbidity and 0.12 cases of mortality are prevented annually. Although the perceived risk of transfusion transmitted B19V infection was low, half of the treating physicians favored anti-B19V screening.Conclusion: The estimated mortality and morbidity caused by B19V infection was low in the risk groups. The cost-effectiveness ratio is similar to other blood safety screening measures. No guidance exists to evaluate the acceptability of this ratio. The explicit overview of costs and effects may further guide the discussion of the desirability of B19V safe blood products. [ABSTRACT FROM AUTHOR]

Background: Launched in 2013, Canadian Blood Services' Cord Blood Bank (CBS' CBB) has built a high-quality, ethnically diverse cord blood repository that aims to reduce ethnic disparity in accessing suitable units for transplantation.Methods and Results: As of December 2016, 2000 units have been banked. The self-reported maternal ethnicity was 58% non-Caucasian. Overall, 26% of units were classified as multi-ethnicity with Caucasian (84%) most frequently observed in combination with Asian, First Nations (predominant indigenous peoples in Canada south of the Arctic Circle), or African ethnicity. Utilization scores that incorporate total nucleated and CD34+ cell counts in the CBS' CBB were associated with greater likelihood of utilization compared with the international inventory of units (p < 0.05). The distribution of utilization scores was similar for Caucasians compared with non-Caucasians (p < 0.05). Using HLA genotypes of cord blood units and their mothers, we determined probable ethnic assignments for each haplotype using HaploStats (National Marrow Donor Program). Significant increases in HLA-match likelihoods are predicted for all ethnicities as the inventory grows to its target of 10,000 units and the gap in HLA-match likelihoods for Caucasian and non-Caucasian patients progressively declines.Conclusions: The CBS' CBB inventory is predicted to have high HLA-matching likelihoods across a broad spectrum of ethnic groups, improving access to high-quality stem cell products for all patients. [ABSTRACT FROM AUTHOR]

Background: ABO-incompatible platelet transfusions are common, and transfusions with ABO-incompatible plasma are increasing with the use of group A plasma and group O whole blood (WB) in emergencies. Many centers screen blood products for anti-A and/or anti-B titers to help prevent hemolysis from ABO-incompatible transfusions, yet titer methods and definition of high titers are not standardized.Study Design and Methods: This international multicenter study collected data on anti-A and anti-B titer practices for plasma, apheresis platelet (AP), and WB units from January 2015 through December 2017 to determine the prevalence of high-titer units using local definitions.Results: A total of 87,701 plasma, AP and WB units were screened for high-titer anti-A and/or anti-B. High-titer detection rates for group A plasma ranged 0%-13.6%; group A AP 2.7%-9.3%; group O AP 2.3%-65.7%; and group O WB 6.4%-20.7%. At the one center that collected group B AP, the high-titer rate was 10.9%. High-titer rates varied from month to month, as well as between years for a given month. There was no clear pattern of when high-titer units were donated.Conclusion: The prevalence of high-titer plasma, AP, and WB units varies by titer method and local definition of high titer. Even at the lowest titer threshold of 50, a significant proportion of units had a high-titer antibody, although the clinical relevance of this finding needs further investigation. [ABSTRACT FROM AUTHOR]

Background: West Nile virus (WNV) is transmitted to humans through mosquito bites and can be further transmitted to humans through transfusion or transplantation. Because most infected individuals are asymptomatic, blood donor screening is important in areas where WNV is endemic. These studies evaluated the performance of a new test for detection of WNV RNA in blood donations.Study Design and Methods: Analytical performance evaluation included sensitivity, specificity, inclusivity, and correlation. A clinical specificity study was conducted at four blood donor testing laboratories in parallel with the cobas TaqScreen WNV Test (Roche Molecular Systems, Inc.).Results: The 95% and 50% limit of detection for cobas WNV was 12.9 copies/mL (95% confidence interval [CI], 10.8-16.3) and 2.1 copies/mL (95% CI, 1.9-2.4) for WNV lineage 1, respectively, and 6.2 copies/mL (95% CI, 4.8-8.9) and 1.1 copies/mL (95% CI, 0.8-1.3) for WNV lineage 2, respectively. Clinical specificity was 100% in 10,823 donor samples tested individually (95% CI, 99.966%-100%) and 63,243 tested in pools of 6 (95% CI, 99.994%-100%). Samples of other members of the Japanese encephalitis virus serocomplex, including St Louis encephalitis, Japanese encephalitis, Murray Valley encephalitis, Usutu, and Kunjin viruses were detected by cobas WNV.Conclusion: The cobas WNV test for use on the cobas 6800/8800 System, a fully automated test system, demonstrated high sensitivity and specificity and is suitable for the detection of WNV in blood donors. [ABSTRACT FROM AUTHOR]

Background: The major aims of the RBC-Omics study were to evaluate the genomic and metabolomic determinants of spontaneous and stress-induced hemolysis during RBC storage. This study was unique in scale and design to allow evaluation of RBC donations from a sufficient number of donors across the spectrum of race, ethnicity, sex, and donation intensity. Study procedures were carefully piloted, optimized, and controlled to enable high-quality data collection.Methods: The enrollment goal of 14,000 RBC donors across four centers, with characterization of RBC hemolysis across two testing laboratories, required rigorous piloting and optimization and establishment of a quality assurance (QA) and quality control (QC) program. Optimization of WBC elution from leukoreduction (LR) filters, development and validation of small-volume transfer bags, impact of manufacturing and sample-handling procedures on hemolysis parameters, and testing consistency across laboratories and technicians and over time were part of this quality assurance/quality control program.Results: LR filter elution procedures were optimized for obtaining DNA for analysis. Significant differences between standard and pediatric storage bags led to use of an alternative LR-RBC transfer bag. The impact of sample preparation and freezing methods on metabolomics analyses was evaluated. Proficiency testing monitored and documented testing consistency across laboratories and technicians.Conclusion: Piloting and optimization, and establishment of a robust quality assurance/quality control program documented process consistency throughout the study and was essential in executing this large-scale multicenter study. This program supports the validity of the RBC-Omics study results and a sample repository that can be used in future studies. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses articles in the issue on topics including design of red blood cells (RBC)-Omics program; vitro hemolysis testing of donated RBCs from recalled RBC-Omics donors; and developing methods for performing genome-wide association studies.

BACKGROUND: Three probable cases of transfusion‐transmitted (TT) parvovirus B19 (B19V) occurred in Australia between 2014 and 2017. This study aimed to determine the B19V DNA prevalence among blood donors, to model the risk to recipients of fresh components, and to assess risk management options. STUDY DESIGN AND METHODS: Plasma samples from 4232 donors were tested for B19V DNA by polymerase chain reaction. Reactive samples were confirmed and viral load determined. A transmission‐risk model was used to estimate recipient risk, and the risk from community exposure was estimated using seroprevalence data. RESULTS: Two samples (0.0473%, 95% confidence interval [CI] 0.0130‐0.172) confirmed positive for B19V DNA had a potentially infectious viral load of 105 IU/mL or higher. The estimated risk of a TT‐B19V–associated significant complication was low overall at approximately 1 in 300,000 (95% CI, 1 in 82,000 to 1 in 1 million) fresh components transfused, with 3.1 (95% CI, 0.85‐11.3) complications modeled per year. Among vulnerable recipient groups, the risk was higher than 1 in 15,000 patients, but the risk from community exposure far exceeded the transfusion risk for all patient and age groups. CONCLUSION: In the context of the small contribution of transfusion to the burden of B19V disease, the significant costs that would be incurred by any strategy to reduce the risk, and given the significant uncertainties and likely overestimation of the risk, we conclude TT‐B19V is a tolerable risk to blood safety, despite being high for some vulnerable recipient groups. [ABSTRACT FROM AUTHOR]

Keywords: immunohematology (RBC serology, blood groups); transfusion practices EN immunohematology (RBC serology, blood groups) transfusion practices 2429 2430 2 12/11/22 20221201 NES 221201 A 44-year-old G6P3 female at 25 weeks gestational age was transferred to our tertiary care center for threatened preterm birth and a stat cesarean section was performed upon presentation for abnormal fetal tracing. The lipemia is the cause of the opaque (dark gray) plasma suspended above the gel matrix in the last two gel columns in Figure 2A and in the two gel columns in Figure 2B gl The patient had an oral glucose tolerance test the day prior, which was suspected to have precipitated diabetic ketoacidosis (DKA) and exacerbated her underlying hypercholesterolemia. The gel cards were manually read and testing using saline IAT confirmed the patient's blood group and negative antibody screen. [Extracted from the article]

Background: Published studies demonstrate that placental blood samples provide acceptable results for various laboratory tests, but these studies did not include pretransfusion testing. The aim of this study was to show concordance between heel stick and placental blood sample pairs for pretransfusion testing and to validate tube and gel method for placental samples. Using placental blood samples for pretransfusion testing potentially reduces the amount of blood collected from newborns for initial laboratory tests.Study Design and Methods: Placental samples were collected for pretransfusion tests at birth from 32 newborns with less than 2000 g birthweight and less than 35 weeks to compare the results with the heel stick samples from the same newborns. ABO and D typing, direct antiglobulin test (DAT) with IgG, and antibody screen tests were performed on these sample pairs. For ABO and D typing both tube and gel methods were used to validate both methods for the placental samples.Results: This study shows 100% concordance in 32 sample pairs for ABO, D, and DAT tests. Antibody screen results were compared on 29 sample pairs. All 28 sample pairs were concordant, but one placental blood sample was more sensitive to detect a weak maternal antibody than its corresponding heel stick sample was.Conclusion: The results of this study validated that placental blood samples can be used in place of heel stick samples and are suitable for pretransfusion testing. This study also validated ABO and D typing by tube and gel methods for placental samples. [ABSTRACT FROM AUTHOR]

The current reference method in the United States for measuring in vivo population red blood cell (RBC) kinetics utilizes chromium-51 (51 Cr) RBC labeling for determining RBC volume, 24-hour posttransfusion RBC recovery, and long-term RBC survival. Here we provide evidence supporting adoption of a method for kinetics that uses the biotin-labeled RBCs (BioRBCs) as a superior, versatile method for both regulatory and investigational purposes. RBC kinetic analysis using BioRBCs has important methodologic, analytical, and safety advantages over 51 Cr-labeled RBCs. We critically review recent advances in labeling human RBCs at multiple and progressively lower biotin label densities for concurrent, accurate, and sensitive determination of both autologous and allogeneic RBC population kinetics. BioRBC methods valid for RBC kinetic studies, including successful variations used by the authors, are presented along with pharmacokinetic modeling approaches for the accurate determination of RBC pharmacokinetic variables in health and disease. The advantages and limitations of the BioRBC method-including its capability of determining multiple BioRBC densities simultaneously in the same individual throughout the entire RBC life span-are presented and compared with the 51 Cr method. Finally, potential applications and limitations of kinetic BioRBC determinations are discussed. [ABSTRACT FROM AUTHOR]

An introduction is presented which discusses the use of whole blood (WB) pathogen reduction (PR) with rapid diagnostic tests (RDTs) for transfusion-transmitted infection (TTI) testing in low-income countries such as Africa.

Background: Platelets (PLTs) are prone to activation and the release of biologic response modifiers (BRMs) under storage conditions. The transfusion inflammatory reaction in the vascular compartment involves endothelial cell activation due to cell-cell interactions and BRMs infused with the blood products. Endocan/ESM-1 is a proteoglycan secreted by endothelial cells under the control of proinflammatory cytokines. We aimed to measure endocan activity in supernatants of PLT components (PCs), implicated in serious adverse reactions (SARs) or not (no.AR), sampled at different stages during storage.Study Design and Methods: PLT function, by quantification of soluble CD62P, and their ability to produce endocan were assessed. Functional testing of PC supernatants was performed on EA.hy926 endothelial cells in vitro by exposing them to PC supernatants from each group (no.AR or SARs); EA.hy926 activation was evaluated by their production of interleukin (IL)-6 and endocan.Results: PLT endocan secretion was not induced in response to PLT surface molecule agonists, and no significant correlation was observed between sCD62P and endocan concentration after PLT activation. However, we observed a significant increase in the secretion of IL-6 and endocan after EA.hy926 activation by all PC supernatants. IL-6 and endocan secretion were significantly higher for cells stimulated with SAR than those stimulated with no.AR PC supernatants, as well as cell apoptosis.Conclusion: The correlation between the secretion of endocan and that of IL-6 by endothelial cells suggests that endocan can be used as a predictive marker of inflammation for the quality assessment of transfusion grade PLTs. [ABSTRACT FROM AUTHOR]

Background: Resource-limited countries in Africa experience blood shortages. Understanding clinical drivers of blood demand can inform strategies to increase blood availability.Study Design and Methods: From a national representative sample of 42 hospitals in Tanzania, patient records and requests for whole blood (WB) and red blood cells (RBCs) to treat anemia were analyzed using data collected prospectively from June through September 2013. Abstracted data included cause of anemia, number of requested units, clinical signs, and pretransfusion hemoglobin (Hb) levels. Weighted projections of nationwide drivers of blood demand for the year, 2013, were calculated. Mean posttransfusion Hb levels were estimated, and blood requests were assessed for clinical appropriateness.Results: Malaria was the leading driver of blood demand for anemia among children, accounting for 67% (55,949 units; standard deviation [SD], 1911 units) of projected units requested for children in 2013. Maternal hemorrhage was the leading driver of blood demand for anemia among adults, accounting for 21% (31,321 units; SD, 963 units) of projected units requested. Seventeen percent (26,133 units; SD, 1013 units) of projected requested units were deemed inappropriate. Adults with severe anemia had a mean Hb level of 3.7 g/dL and a mean of 1.6 WB or RBC units per request, resulting in an estimated mean posttransfusion Hb level of 5.3 g/dL.Conclusions: Strategies to prevent and treat underlying causes of anemia and decrease inappropriate blood requests will likely increase blood availability. Restrictive blood ordering practices seen in adults with severe anemia suggests undertreatment of anemia and may result in an underestimation of the national blood demand. [ABSTRACT FROM AUTHOR]

Background: Emerging transfusion-transmissible pathogens, including arboviruses such as West Nile, Zika, dengue, and Ross River viruses, are potential threats to transfusion safety. The most prevalent arbovirus in humans in Australia is Ross River virus (RRV); however, prevalence varies substantially around the country. Modeling estimated a yearly risk of 8 to 11 potentially RRV-viremic fresh blood components nationwide. This study aimed to measure the occurrence of RRV viremia among donors who donated at Australian collection centers located in areas with significant RRV transmission during one peak season.Study Design and Methods: Plasma samples were collected from donors (n = 7500) who donated at the selected collection centers during one peak season. Viral RNA was extracted from individual samples, and quantitative reverse transcription-polymerase chain reaction was performed.Results: Regions with the highest rates of RRV transmission were not areas where donor centers were located. We did not detect RRV RNA among 7500 donations collected at the selected centers, resulting in a zero risk estimate with a one-sided 95% confidence interval of 0 to 1 in 2019 donations.Conclusion: Our results suggest that the yearly risk of collecting a RRV-infected blood donation in Australia is low and is at the lower range of previous risk modeling. The majority of Australian donor centers were not in areas known to be at the highest risk for RRV transmission, which was not taken into account in previous models based on notification data. Therefore, we believe that the risk of RRV transfusion transmission in Australia is acceptably low and appropriately managed through existing risk management, including donation restrictions and recall policies. [ABSTRACT FROM AUTHOR]

Background: Maritime medical capability may be compromised by blood resupply. Air-dropped red blood cells (RBCs) is a possible mitigation factor. This study set out to evaluate RBC storage variables after a simulated parachute air drop into the sea, as limited data exist.Study Design and Methods: The air load construction for the air drop of blood was subject to static drop assessment to simulate a worst-case parachute drop scenario. One control and two test Golden Hour shipping containers were each packaged with 10 RBC units. The control box was not dropped; Test Boxes 1 and 2 were further reinforced with waterproof boxes and underwent a simulated air drop on Day 7 or Day 8 postdonation, respectively. One day after the drop and once a week thereafter until Day 43 of storage, RBCs from each box were sampled and tested for full blood counts, hemolysis, adenosine triphosphate, 2,3-diphosphoglycerate, pH, extracellular potassium, glucose, lactate, deformability, and RBC microvesicles.Results: The packaging configuration completed the air drop with no water ingress or physical damage. All units met UK specifications for volume, hemoglobin, and hemolysis. There were no significant differences for any of the variables studied between RBCs in the control box compared to RBCs in Test Boxes 1 and 2 combined over storage.Conclusion: The test proved that the packaging solution and the impact of a maritime air drop as performed in this study, on Day 7 or Day 8 postdonation, did not affect the in vitro quality of RBCs in SAGM over storage for 35 days. [ABSTRACT FROM AUTHOR]

Background: Rapid analytics to predict circulating hematopoietic stem cells are valuable for optimal management of mobilization, particularly for the use of newer and costly mobilization agents such as plerixafor.Study Design and Methods: We used stepwise, linear multiple regression modeling applied to cell population data collected by routine hematology analyzers (Beckman Coulter DxH 800) on patients undergoing autologous stem cell collection (n = 131). Beta coefficients were used to derive a formula for a stem cell index (SCI). We then tested the correlation of SCI with stem cell counts and performance of the SCI as a predictor of poor mobilization with external validation in a separate cohort (n = 183).Results: The SCI correlated strongly with CD34 counts by flow cytometry (r = 0.8372 in the development cohort, r = 0.8332 in the external validation cohort) and compares favorably with other rapid stem cell enumerating technologies. In the external validation cohort, the SCI performed well as a predictor (receiver operating characteristic area under the curve, 0.9336) of poor mobilization (CD34 count < 10), with a sensitivity of 72% and a specificity of 93%. When prevalence of poor mobilization was 33%, this resulted in a positive predictive value of 83% and a negative predictive value of 87%. The SCI also showed promise in tracking responses to plerixafor administration.Conclusion: The findings demonstrate the utility of the cell population data collected by hematology analyzers to provide rapid data beyond standard complete blood counts, particularly for stem cell count prediction, requiring no additional reagents, specimen, or instrumentation. [ABSTRACT FROM AUTHOR]

After 30 years of hematopoietic stem cell use for various indications, umbilical cord blood is considered as an established source of cells with marrow and postmobilization peripheral blood. The limited number of cells still remains a problematic element restricting their use, especially in adults who require to be grafted with a higher cell number. Improving the quality of harvested cord blood, at least in terms of volume and amount of cells, is essential to decrease the number of discarded units. In this review, we examine several variables related to parturient, pregnancy, labor, delivery, collection, the newborn, umbilical cord, and placenta. We aim to understand the biologic mechanisms that can impact cord blood quality. This knowledge will ultimately allow targeting donors, which could provide a rich graft and improve the efficiency of the collection. [ABSTRACT FROM AUTHOR]

Background: Chronic myeloid leukemia (CML) is a common hematologic malignancy; however, its occurrence during pregnancy is unusual due to its low prevalence in females of childbearing age. There are conflicting reports of how to best manage CML in pregnancy, particularly in the setting of leukocytosis.Hemapheresis: A 30-year-old female was diagnosed with CML at 18 weeks' estimated gestational age. On initial presentation she reported fatigue, night sweats, and early satiety, and was found to have a white blood cell (WBC) count of 69.3 × 109 /L and platelet count of 366 × 109 /L. Her disease was managed during pregnancy using interferon-α alone despite persistent leukocytosis.Conclusion: CML may be effectively managed during pregnancy, even in the setting of leukocytosis, without the application of leukocytapheresis. Management relies not only upon the coordination of drug therapy and fetal monitoring, but requires close communication between multiple medical disciplines. Leukocytapheresis has been safely performed during pregnancy and may be a suitable adjunct management strategy in pregnant patients diagnosed with CML with specific clinical presentations, such as hyperleukocytosis (WBC count > 150 × 109 /L) and/or symptomatic leukostasis. [ABSTRACT FROM AUTHOR]

Background: Massive transfusion is a response to massive uncontrolled hemorrhage. To be effective, it must be timely and address the patient's needs for blood volume, oxygen transport, and hemostasis.Study Design and Methods: A review was performed on all activations of the massive transfusion protocol (MTP) in a hospital with large emergency medicine, trauma, and vascular surgery programs. Indications, transfused amounts, and outcomes were determined for each MTP event to determine appropriateness of MTP use. Results are presented as descriptive statistics, categorical associations, and simple linear trend relationships.Results: The MTP was activated 309 times in 2016. Of these episodes, 237 were for trauma, 29 for gastrointestinal bleeding, 16 for ruptured abdominal aortic aneurisms, and 25 for a variety of other causes. Trauma-related MTP activations had a mean injury severity score of 32. Blood use averaged 6.6 units of red blood cells (RBCs), 6.5 units of plasma, and 1.2 units of apheresis platelets. Fourteen activations ended without the administration of any blood products, and 45 (14%) did not meet the critical administration threshold of three components. Only 60 (19%) activations met the historic definition of massive with at least 10 units of RBCs administered. Mortality was 15% for the trauma-related activations.Conclusions: Massive transfusion protocol activations were frequent and conducted with high fidelity to the 1:1:1 unit ratio standard. Making blood components available quickly was associated with low rates of total component usage and low mortality for trauma patients and was not associated with overuse. [ABSTRACT FROM AUTHOR]

Background: The objective was to determine if antenatal anemia is associated with postpartum red blood cell (RBC) transfusion.Study Design and Methods: Women who gave birth at a regional, tertiary care maternity hospital between December 1, 2015, and September 31, 2016, with a documented antenatal hemoglobin (Hb) concentration were included. Women were grouped into those who were either anemic (Hb < 11.0 g/dL) or nonanemic. The change in Hb concentration and RBC transfusion rates were compared between the anemic and nonanemic women, as well as by the mode of delivery (vaginal vs. Cesarean). To estimate the volume of blood loss in a normal delivery, the mean postpartum Hb concentration decrease for the not transfused women was calculated by subtracting the nadir postpartum Hb concentration from the antenatal Hb concentration and averaging these concentrations according to delivery route.Results: Of 8039 cases analyzed, 1562 (19%) had antenatal anemia and 6477 (81%) were nonanemic. Of the anemic women, 57 (3.6%) received an RBC transfusion compared to 49 (0.76%) of the nonanemic women (p = 0.0001; odds ratio, 4.97; 95% confidence interval, 3.38-7.31). Antenatal anemia was significantly associated with receiving an RBC transfusion regardless of mode of delivery for those who delivered vaginally (p = 0.0001) or by Cesarean (p = 0.0001) compared to those who were nonanemic. The mean postpartum Hb concentration decrease was 1.12 ± 1.12 g/dL for vaginal deliveries and 1.34 ± 0.21 g/dL for Cesarean deliveries in the not transfused women (p = 0.0001).Conclusion: Although the overall rate of transfusion was low, antenatal anemia was significantly associated with receiving a postpartum RBC transfusion. [ABSTRACT FROM AUTHOR]

Background: Patients with hematologic malignancies receive large numbers of blood transfusions, and transfusion practices for this patient group are increasingly being scrutinized by randomized controlled trials. However, no studies so far have presented current transfusion statistics on a population level for this patient group.Study Design and Methods: A retrospective descriptive study was conducted that was based on the Scandinavian Donations and Transfusions Database (SCANDAT2), which includes data on all blood donations and transfusions in Sweden and Denmark since the 1960s. Incident cases of hematologic malignancies were identified in the Swedish Cancer Register between 2000 and 2010. Cases were divided into nine patient groups based on diagnosis.Results: A total of 28,693 patients were included in the cohort. Overall, the transfusion pattern varied depending on diagnosis and age. Patients with aggressive and acute diagnoses generally received more transfusions with immediate decline in transfusion incidence after diagnosis, whereas chronic diagnoses generally maintained more stable, but lower, transfusion incidence. In general, patients with leukemia received more transfusions than patients with lymphoma, and patients with acute leukemia as well as patients that had undergone allogeneic stem cell transplantations received the most transfusions. Within 2 years after diagnosis, patients with acute myeloid leukemia diagnosed at ages 0 to 65 years received on average between 30 to 40 red blood cell transfusions and platelet transfusions, respectively, corresponding to direct material costs close to 200,000 SEK (23,809 USD).Conclusion: Results from this population-based overview of blood use in hematologic malignancies showed high variability depending on diagnosis and age. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to determine the incidence, risk factors, and outcome of transfusion-associated circulatory overload (TACO) in a cohort of mixed intensive care unit patients and to compare risk factors with those for cardiac overload in the absence of transfusion.Study Design and Methods: In a retrospective cohort study, patients who developed TACO were compared using multivariate analysis of two control groups: patients without pulmonary deterioration who received transfusion and patients who developed circulatory overload in the absence of transfusion.Results: TACO was diagnosed in 66 of 1140 patients who received transfusions (5.8%). A total of 585 control transfusion recipients and 76 control patients who developed circulatory overload also were identified. Risk factors were the referring specialties cardiology (odds ratio [OR], 13.6; 95% confidence interval [CI], 5.1-35.7; p ≤ 0.001) and cardiothoracic surgery (OR, 8.8; 95% CI, 3.7-20.7; p ≤ 0.001), history of cardiac failure (OR, 2.4; 95% CI, 1.2-4.6; p = 0.01), continuous veno-venous hemofiltration (OR, 3.2; 95% CI, 1.2-8.9; p = 0.03), and degree of positive fluid balance (OR, 1.15; 95% CI, 1.07-1.24; p ≤ 0.001), which was associated less with the onset of TACO compared with circulatory overload (OR, 0.89; 95% CI, 0.82-0.97; p = 0.005). Patients in the TACO group had a longer length of stay in the intensive care unit compared with the transfusion and circulatory overload controls groups (median, 7.2 vs. 4.3 vs. 4.4 days; p = 0.001 vs. p = 0.008).Conclusions: The incidence of TACO is high in a mixed intensive care unit population. The risk factors identified for TACO are cardiac failure, renal failure, and degree of positive fluid balance. A positive fluid balance may be less essential in the onset of TACO than in the onset of circulatory overload in the absence of transfusion. [ABSTRACT FROM AUTHOR]

Background: Intravenous immunoglobulins (IVIG) are a biologic product originally developed to treat immunocompromised patients. In the past decades, there has been increased utilization of IVIG in autoimmune conditions. The objectives were to evaluate the clinical use of IVIG in the largest tertiary medical center in Israel and to determine top uses, estimate off-label usage, and assess consumption of this blood product.Study Design and Methods: We conducted an observational, retrospective study involving all patients who received IVIG from 2007 through 2015. Subjects were classified into five groups according to the indication for treatment.Results: A total of 1117 patients were identified. The mean (±SD) ages of adults and children were 55 ± 17 and 8 ± 7 years, respectively. Most common indication for treatment were immune-mediated conditions (54%), followed by secondary immunodeficiency (28%), primary immunodeficiency (10%), infections (4%), and miscellaneous (4%). The main immune-mediated conditions treated were hematologic disorders (305 patients, 27%), neurologic disorders (219 patients, 20%), and rheumatologic conditions (79 patients, 7%). Overall, a significant change in study period was observed in the number of patients (p < 0.001), consumption of IVIG (p < 0.01), and amount of IVIG administered per patient (p < 0.01). Fifty-six percent of the IVIG infusions were given for off-label Food and Drug Administration (FDA) indications.Conclusion: In this study, we demonstrated that immune-mediated conditions represent the majority of indications for treatment with IVIG. We observed a 417% increase in IVIG administration (g) over time, attributed mainly to autoimmune diseases. Many indications are still off-label according to FDA recommendations. [ABSTRACT FROM AUTHOR]

Background: Cell therapy products are often stored and transported between sites. The aim of this study was to determine the effect of storage temperature, solution, and cell concentration on nonmobilized, peripheral blood-derived mononuclear cells (MNCs).Study Design and Methods: This was a multicenter prospective study involving healthy volunteers who underwent nonmobilized MNC collection by apheresis. Products were processed at local laboratories and concentrated to either 100 × 106 or 300 × 106 nucleated cells/mL in 5% human serum albumin (HSA) or HypoThermosol FRS (HT; BioLife Solutions). Products were stored at room temperature (RT; 20-25°C) or refrigerated temperatures (2-8°C) with assessment at 0, 24, 48, and 72 hours. NC and MNC concentration, viability, and flow cytometric analysis for CD3, CD4, CD8, CD14, CD19, CD25, and CD56 were measured.Results: Viability decreased over time for all conditions tested. Refrigerated storage preserved viability greater than RT storage, especially for products with a higher cell concentration. RT maintenance with a high cell concentration was associated with a relative loss of CD14- and CD4-positive cells, whereas the concentration of cells positive for other markers tested did not vary. Finally, there was delayed decrease in pH when using HT compared with HSA; however, there was no difference in viability between the two solutions.Conclusion: Low cell concentrations (approx. 100 × 106 cells/mL), refrigerated temperatures, and HT storage solution appear to be the optimal conditions for storing nonmobilized, peripheral blood-derived MNC products. [ABSTRACT FROM AUTHOR]

Background: Molecular tests designed to detect the presence of active RHD gene among D- donors have been successfully applied in people of European ancestry, but not in admixed populations with a considerable frequency of RHD*Ψ. Our goal was to evaluate the performance of a molecular screening tool for identifying active RHD alleles among Brazilian blood donors classified as D- C+ and/or E+.Study Design and Methods: Pools of five DNA samples of serologically D- C+ and/or E+ donors were checked by a RHD polymerase chain reaction (PCR) assay specific for RHD Intron 4 and Exon 7. When a pool result was positive, samples were genotyped individually for RHD Intron 4 and Exon 7, RHD*Ψ, RHCE*Cc, and RHD zygosity. Donors suspected of active RHD gene were further evaluated by whole-coding region and flanking intron direct sequencing.Results: A total of 405 donors were included. Two percent exhibited active RHD gene, codifying D-weak (38 and 45) or DEL phenotype. The most prevalent DEL allele was RHD*DEL1 (c.1227G>A), which is proven to be immunogenic. A high frequency of RHD*Ψ was detected in the donors with nondeleted RHD alleles (31%), far superior to the frequency of RHD variant alleles (15.5%). The proposed approach presented sensitivity of 100% and specificity of 85.7% for identifying active RHD gene.Conclusion: The strategy of checking D- donors with RHD PCR followed by exclusion of RHD*Ψ allele has proved efficient in identifying weak-D and DEL phenotype in the Brazilian population. [ABSTRACT FROM AUTHOR]

Background: The Digital Intern (DI) is an electronic decision support tool for the management of organ donors. One algorithm determines the dose, in units of red blood cells to be transfused, based on hematocrit (Hct) thresholds and targets. The effectiveness of the transfusion dose calculated by the DI in terms of achieving the selected Hct target and the duration of the targeted dose is not known.Study Design and Methods: This was a retrospective study to describe the outcomes of transfusions prescribed by the DI. Pre- and posttransfusion Hct levels were compared to define response and all posttransfusion Hct values were plotted to evaluate the duration of the prescribed dose.Results: A total of 120 organ donors were studied and 22 donors had 28 transfusions (six were transfused twice). The transfused donors were a mix of trauma and medical admissions and brain death and cardiac death donors. The transfusion target of 24% Hct was attained in 96% of transfusions. The mean number of units transfused was 1.4 and the mean time from transfusion to procurement was 19.8 hours. There was a decline in Hct over time after transfusion in all but one case with a mean decline of 1.9% Hct over 13 hours. Six donors were transfused twice, likely due to a longer donor time period (41.7 hr vs. 27 hr).Conclusions: The DI provided transfusion dosing that achieved the desired threshold in the majority of organ donors transfused. Ongoing work focuses on application of this technology to transfusions in general patient populations. [ABSTRACT FROM AUTHOR]

Background: Fibrinogen concentrate is the preferred choice for fibrinogen replacement in congenital fibrinogen deficiency. This study investigated hemostatic efficacy of a new plasma-derived, double virus-inactivated (using two dedicated virus inactivation/elimination steps) human fibrinogen concentrate for on-demand treatment of bleeding episodes (BEs) and surgical prophylaxis.Study Design and Methods: In this planned interim analysis of a prospective, multinational Phase III study (NCT02267226), 13 patients with afibrinogenemia (≥12 years) received fibrinogen concentrate (FIBRYGA, Octapharma AG). Hemostatic efficacy was assessed by investigators and an independent data monitoring and endpoint adjudication committee (IDMEAC) using objective four-point criteria and by thromboelastometry maximum clot firmness (MCF).Results: Fibrinogen concentrate was used on-demand to treat 23 BEs in 11 patients, with 21 (91.3%) requiring a single infusion only. Treatment success was 95.7% (90% confidence interval [CI], 0.81-1.00; assessment missing for one BE) by investigators and 100% (90% CI, 0.88-1.00) by IDMEAC. Mean MCF increased significantly from 0.0 to 6.5 mm (95% CI, 5.65-7.40; p < 0.0001) at 1 hour postinfusion of a median (range) dose of 58.8 (33.9-101.7) mg/kg per BE. Four patients received fibrinogen concentrate as surgical prophylaxis, with intraoperative and postoperative treatment success rated 100% (90% CI, 0.50-1.00) by investigators and IDMEAC (median [range] dose per surgery 93.5 [34.1-225.4] mg/kg). No additional hemostatic interventions were required. No deaths, thromboses, or seroconversions were reported.Conclusion: These data showed that the new fibrinogen concentrate was efficacious for on-demand treatment of acute bleeding and surgical prophylaxis in congenital afibrinogenemia patients. [ABSTRACT FROM AUTHOR]