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Several Tanzanian regions fall short of annual whole blood donation targets. Understanding what motivates first-time and repeat donors, and whether certain recruitment and retention strategies may affect blood safety, is essential to improving retention and ensuring a safe blood supply. This study aimed to identify variables associated with pre-donation deferral, donor retention and transfusion-transmitted infection (TTI) prevalence in Tanzanian (candidate) blood donors. Between February and April 2023, 1471 (candidate) donors were surveyed at 43 mobile blood collections across 5 Tanzanian regions to collect data on socio-demographics, motivations, incentives received after donation and recruitment methods used. Multivariable logistic regression modelling was performed on a dataset of 675 participants to identify predictors of pre-donation deferral, retention and TTI rates. Pre-donation deferral was more likely among females, first-time donors, those recruited via multiple methods and those attending collections at public places (all p < 0.05). Donor retention was positively associated with increasing age, having received an incentive and donating at Nyarugusu refugee camp (all p < 0.05). Donors mainly motivated by receiving test results had significantly higher TTI rates than those wanting to save lives. TTI rates were lower in those donating at schools/universities and Nyarugusu compared to public places. This study revealed multiple important predictors of pre-donation deferral, retention and TTI rates in Tanzanian (candidate) blood donors. Further research is needed to identify the most effective donor recruitment and retention strategies and to assess the value of targeting specific populations for a more stable blood supply in Tanzania.
The global blood product shortage is a persistent problem that urgently needs addressing. Research has investigated the effects of incentives, different interventions and different modes of communication on promoting blood donation; yet, there has been no systematic review comparing interactive communication-based interventions. Identifying effective methods to recruit and retain blood donors could inform future intervention design and improve resource allocation, thereby reducing strain on blood-product supply. This review brings together relevant literature found on Medline, CENTRAL, Embase and PsychINFO to address the following questions: 'What are the most effective interactive interventions for promoting blood donation?' and 'Are these different between encouraging first-time and returning blood donors?' A total of 36 studies were included in this review. Overall, the quality of research on interactive communication-based interventions was poor, with several studies lacking sufficient detail to make clear conclusions. Evidence for three common interventions (phone calls, educational sessions and motivational interviews) was conflicting. Additionally, there was limited research into web-based interventions and recruitment of first-time donors. Reporting of communication interventions for blood donation could be improved, and our review suggests that a more heterogeneous approach to donor recruitment may be advantageous.
Di(2-ethylhexyl) phthalate (DEHP) has been used in blood bag manufacturing for decades, but concern about its potential toxicity has prompted regulatory efforts to eliminate it from medical devices, including blood bags. As manufacturers transition to non-DEHP materials, evaluation is required to ensure blood component quality in modified bag systems. Investigational Trima Accel disposables were developed using plasticizers approved as DEHP alternatives per the European Pharmacopoeia. Red blood cells (RBCs) were collected, and two consecutive studies evaluated in vitro quality and in vivo RBC recovery. Leukoreduced RBCs (LR-RBCs) were stored in Additive Solution 3 (AS-3) at 2-6°C for 42 days. In vitro quality parameters measured on days 0, 35 and/or 42 were assessed against US Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) acceptance criteria. A radiolabelling study evaluated in vivo 24-h RBC recovery using the FDA criteria. Key FDA criteria were met, including haemolysis, which remained below the acceptable limit throughout 42 days of storage. All EDQM criteria were met except Day 0 haematocrit, with 8 units outside the specified range and the confidence interval (CI) lower bound at 77.6%. All FDA criteria for in vivo 24-h RBC recovery were met. Apheresis LR-RBCs collected with Trima Accel systems using non-DEHP disposables and stored for 42 days met key FDA and EDQM criteria, with any in vitro parameter failures considered artefactual. Products also met FDA's 24-h in vivo RBC recovery criteria, supporting their use as acceptable transfusable products.
The para-Bombay phenotype is characterized by H antigen deficiency and the natural production of antibody against the I and H antigens (anti-IH), some of which are occasionally clinically significant. It genetically results from the presence of two non-functional FUT1 alleles coupled with at least one functional FUT2 allele. We present the serological and molecular characterization of a para-Bombay phenotype case, which led to the identification of a novel FUT1 allele. A sample from a blood donor was identified as a result of a discrepancy between forward and reverse typing. This sample subsequently underwent serological typing for A, B and H antigens in accordance with the American Association of Blood Banks Technical Manual. Furthermore, Sanger sequencing and nanopore sequencing were employed to analyse the ABO, FUT1 and FUT2 genes. The donor was found to have an H-deficient phenotype and the presence of anti-IH. Sanger sequencing identified an ABO*A1.01/ABO*O.01.02 genotype. Nanopore sequencing showed a compound heterozygous state in FUT1, represented by the FUT1*01W.09 allele and a novel FUT1 allele carrying the c.[35C>T;133_136dupCGCC] variant. The FUT2 genotype was determined as FUT2*01/FUT2*01W.02.01. This study identifies a novel FUT1 allele characterized by the c.[35C>T;133_136dupCGCC] variant that impairs H antigen expression on red blood cells, thereby contributing to the understanding of FUT1 allele diversity.
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Thawed plasma (TP) can be stored for several days to facilitate rapid emergency transfusion. However, in Japan, the 24-h post-thaw shelf life limit raises concerns about plasma wastage. We evaluated fibrinogen recovery in cryoprecipitate prepared from TP that was stored for 5 days after thawing. Cryoprecipitate was prepared using the one-step method (OSM, n = 12), two-step method (TSM, n = 15) and the TP stored for 5 days post-thaw (n = 15). Cryoprecipitate was prepared using three protocols: OSM, in which fresh frozen plasma (FFP) was thawed once at 2-6°C for 24-30 h; TSM, in which FFP was thawed at 2-6°C, refrozen at -30°C and then thawed again at 2-6°C for 24-30 h; and TP, in which FFP was stored at 2-6°C for 5 days after initial thawing, then refrozen and thawed as in the TSM. All samples were centrifuged after the final thawing to collect the cryoprecipitate. Fibrinogen recovery was calculated from fibrinogen concentrations, and bacteriological testing was performed on the cryoprecipitate prepared from TP. Fibrinogen recovery differed significantly among the groups (p < 0.001), with the highest recovery in the TSM group, followed by the TP and OSM groups. Recovery in the TP group was significantly higher than that in the OSM group. No bacterial growth was detected in any of the samples. Using stored TP to prepare cryoprecipitate could offer a more efficient way to manage resources while supporting emergency transfusion readiness.
Vasovagal reaction (VVR) is the most frequent adverse reaction in blood donation, which usually recovers soon without complications. However, syncopal VVR can result in severe injury due to a fall. Some reports have shown the possibility to prevent VVR with salt-loading prior to blood donation. This semi-randomized controlled study aims to clarify the preventive effect of salt-loading on VVR among whole blood (WB) donors. During the study period, donors who donated 400 mL of WB on odd days were assigned to the salt-loading group and those who donated on even days to the control group. Participants in the salt-loading group were asked to take three tablets containing 0.3 g salt in total. The incidence of VVRs occurring >20 min after needle removal (delayed VVR [dVVR]) did not significantly differ between the two groups. Secondary analysis suggested a possible dose-dependent preventive effect against dVVR (odds ratio [OR]: 0.70; 95% confidence interval [CI]: 0.52-0.94; p = 0.02). The number of delayed syncopal VVR episodes in summer was lower in the salt-loading group than in the control group (n = 1 vs. 8; OR: 0.13; p = 0.04; pre-specified α = 0.0125). There was no significant preventive effect of pre-donation salt-loading on VVR. Further investigations with sufficient number of participants are needed to conclude the suggested dose dependency and seasonal preventive effect on dVVRs.
Complexity science investigates how complex systems behave and how we interact with them. Its implementation in clinical transfusion research is limited, even though human cells, organ systems, bodies, hospitals and blood supply systems are all examples of complex systems. Complexity science can help us to better understand the systems we study using novel and existing research methods. It also highlights that there is always unpredictability in complex systems, challenging us to both accept and cope with this uncertainty. This review provides a brief introduction of complex systems, explores why many transfusion-related research questions should be viewed through the lens of complexity and discusses how we can apply this perspective to transfusion research.
The demand for plasma-derived medicinal products underscores the need to assess health effects of plasma donation. This study examines the association between plasma donation rates and infection risk in a country with voluntary, non-remunerated donation. From 2016 to 2024, 45,615 first-time plasma donors were enrolled in a cohort study with time-varying exposure. Follow-up began 90 days after the first plasma donation, with donation rates recalculated every 90 days. Donation rates were categorized as 0, 1 (reference), 2-3, 4-5 or 6-8 donations. Infection was defined using Danish health registers. Survival models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). The median plasma donation rate was 2 (Q1, 1; Q3, 4). During follow-up, 15,498 donors experienced an infection. A trend of decreasing HRs for infection was observed with higher donation rates compared with a single donation (0 donations: HR: 0.89, 95% CI: 0.86-0.93; 2-3 donations: HR: 0.85, 95% CI: 0.81-0.89; 4-5 donations: HR: 0.65, 95% CI: 0.59-0.72; and 6-8 donations: HR: 0.48, 95% CI: 0.36-0.62). Findings were consistent across multiple regression models. In this study, higher plasma donation rates were associated with lower infection risk. Importantly, this inverse association is likely due to bias inherent to observational designs, particularly the internal healthy donor effect, which limits interpretation. Thus, no causal relationship between plasma donation rates and infection risk can be inferred. This underscores the challenges of assessing plasma donation safety using non-randomized data.
Bedside transfusion errors, especially positive patient identification (PPID), are a risk to patient safety. Bedside electronic transfusion checks (BETC), using barcode-enabled personal digital assistants (PDAs), are recommended to improve safety and efficiency. This study assessed staff satisfaction with BETC versus manual transfusion checks in three large London hospitals. The surveys aimed to compare clinical staff satisfaction with BETC versus the manual system. A cross-sectional survey was conducted immediately after training and 6 months after routine BETC use. The initial (21 questions) and follow-up (15 questions) surveys assessed usability, accuracy, workflow efficiency and patient care impact. Responses were collected via Microsoft Forms and analysed using descriptive statistics and logistic regression, adjusting for job role, experience and hospitals. A total of 2085 staff completed the initial survey (55% response) and 514 the follow-up (13%), predominantly nurses (75%). For group and screen (G&S) labelling, ratings of 'ease of use' and 'accuracy' improved significantly between surveys, while perceived impact on reducing mislabelling remained consistently high (96.2% vs. 94.7%). Compared with manual checks, BETC was rated significantly by clinicians for ease of use (89% → 94%) and accuracy (89% → 95%; both p < 0.001). Improvements were also observed for the time saved by clinical staff (75% → 89%), patient care (77% → 89%), fewer nurses required (79% → 91%) and traceability (80% → 87%), all statistically significant (p < 0.001). BETC was associated with significantly greater clinical staff satisfaction than manual transfusion checks, providing large-scale evidence for their adoption to enhance transfusion safety, efficiency and staff experience.
Blood is indispensable in emergency medical care and serves as mortality. However, in disaster zones and other challenging environments, batch identification and rapid allocation of blood supplies remain particularly difficult. A portable blood batch identification device (PBBID) based on ultra-high-frequency (UHF) radio-frequency identification (RFID) technology was developed to improve the efficiency of blood verification management in complex environments. PBBID has a lightweight foldable cabin and an integrated composite protective layer and UHF RFID antenna and is equipped with a dedicated blood management terminal. Its function, identification rate and accuracy were tested, and blood quality was assessed via blood count, biochemical analysis and haemolysis rate assay. Folded PBBID occupies 24.92% of the expanded volume, unfolding takes 23.68 ± 6.00 s and can identifying 40 blood units in 5.37 ± 0.48 s. During the storage period, fixed-frequency scanning did not significantly affect the quality of red blood cells. However, intensive scanning exceeding 300 times led to a notable increase in the haemolysis rate. With its foldable design, rapid batch identification capability and operational simplicity, PBBID markedly enhances the efficiency and accuracy of blood management in emergency medical rescue. Under conventional conditions, it does not compromise blood quality and can shorten the time required for transfusion and emergency treatment of patients with trauma, potentially establishing it as a valuable tool in pre-hospital and emergency medical rescue operations.
Immunoglobulin A (IgA) deficiency occurs in approximately 1 in 14,000 individuals in Japan. Approximately 32% harbour anti-IgA, most of which are naturally occurring and rarely cause anaphylaxis, although high-titre anti-IgA from alloimmunization can cause severe reactions. A stable supply of IgA-deficient plasma is essential for minimizing this risk. We therefore developed a novel reagent for large-scale identification of IgA-deficient donors. Four mouse monoclonal anti-IgA-producing cell lines were established using the hybridoma method after immunizing mice with IgA protein. Purified antibodies were conjugated to carboxylate-modified polystyrene latex beads for IgA measurement using the latex agglutination method on an automated analyser. Samples with low IgA concentrations were re-tested by enzyme-linked immunosorbent assay (ELISA) for confirmation. Adoption of a dual antibody assay design achieved a detection limit of 0.4 mg/dL, suitable for high-throughput screening. Screening of 24,977 randomly selected donor samples between February 2022 and April 2023 yielded 4 low IgA cases. IgA deficiency was verified by supplemental ELISA, which was required solely for these four samples. Three of four had IgA levels <0.05 mg/dL, which is the most common threshold for identifying IgA-deficient donors. We have developed a new reagent for detecting IgA deficiency. The assay is automatable and appears useful for large-scale screening of blood donors.
Iron deficiency (ID) poses a non-negligible risk for blood donors, yet longitudinal data on iron status and whether low-dose iron-containing supplements improve ID among Japanese donors are scarce. This study aimed to elucidate these issues. Sixty-six healthy Japanese donated 400 mL of whole blood (WB) and underwent scheduled blood samplings. Fourteen participants discontinued follow-up; 52 donors completed the second 400 mL WB donation at Week 48. Participants were subsequently provided supplements containing 6 mg/day of ferric citrate for 12 weeks, with continued monitoring through Week 48; the total duration of participation in the study was 96 weeks. Haematological data were analysed using a linear mixed-effects model. In men, serum ferritin (sFer) declined from 116.2 ng/mL (95% confidence interval [95% CI]: 88.0-144) to 83.7 ng/mL (55.5-112) at Week 4 and returned to baseline by Week 36. In women, sFer decreased from 29.2 ng/mL (21.74-36.7) to 16.6 ng/mL (9.16-24.1) at Week 4 and returned to baseline at Week 24. Recovery of sFer was slower than that of haemoglobin (Hb) in both sexes. Iron supplementation did not affect the recovery of Hb and sFer in men and Hb in women, whereas women showed a significant increase in sFer at Week 16. Although Hb recovered quickly after 400 mL WB donation, replenishment of iron stores took longer. Low-dose iron supplementation facilitated the recovery of iron stores in women. These findings highlight the need for monitoring iron status and may inform strategies to support donor safety and maintain adequate blood supply.
Selective immunoglobulin A (IgA) deficiency is the most common human immunodeficiency, affecting approximately 1 in 500-800 individuals of European ancestry. It is defined by a serum IgA level below 7 mg/dL, with normal immunoglobulin G (IgG) and immunoglobulin M (IgM) levels. Since 1968, severe allergic transfusion reactions have been reported in IgA-deficient patients, often linked to anti-IgA antibodies. This led to recommendations for using IgA-deficient blood components in affected individuals. However, due to the rarity of such reactions, standardized and evidence-based guidelines are lacking, while blood services face logistical challenges maintaining registries of IgA-deficient donors and inventories of compatible products. An international survey was conducted to assess current practices in managing IgA deficiency. The survey explored the frequency of transfusion reactions involving IgA/anti-IgA, detection methods for IgA deficiency and anti-IgA antibodies, reasons for requesting IgA-deficient products, product availability and strategies to facilitate access to IgA-deficient products. Participants from 14 countries/regions across four continents reported a wide variability in defining IgA deficiency, criteria for recommending IgA-deficient products and anti-IgA testing practices. These findings highlight the need for international reference standards and harmonized recommendations to improve the management of IgA-deficient patients. Establishing harmonized best practices and evidence-based guidelines should enhance patient safety and support clinical decision making globally.
The functions of cold-stored platelets (PLTs) have recently been re-evaluated. In Japan, cold storage may be started immediately after blood collection (Day 0, control group), after the period for improving bacterial screening sensitivity has ended (Day 2, DCS2) and after the expiration date of room-temperature storage has ended (Day 5, DCS5). The present study investigated the effects of different cold storage start dates on PLT function. Concentrated PLTs, collected using an apheresis device, were placed in an additive solution (Terumo-platelet additive solution+, Terumo BCT) and then divided into three groups with different cold storage start dates (days 0, 2 or 5). The three groups were stored until Day 21, and various PLT function parameters-including aggregation (adenosine diphosphate [ADP] + collagen-induced and ristocetin-induced aggregation), viscoelasticity (maximum clot firmness [MCF], clotting time and α-angle) and PLT activation (CD62P, PAC-1, CD63 and Annexin V)-were measured and compared. Comparisons of results until Day 14 revealed that among the PLT function parameters examined, only ADP + collagen-induced aggregation and MCF showed a deterioration in DCS2 and DCS5. However, aggregation and MCF values in DCS2 and DCS5 on Day 10 were not markedly different from those in the control group on Day 14 (US expiration date). PLTs stored at room temperature for 2 or 5 days after collection and then refrigerated may be preserved until Day 10.
Paediatric patients with haematological disorders frequently require multiple blood transfusions, increasing their risk of developing irregular antibodies. Because of the immunohaematological differences from adults, patterns of alloimmunization in children may vary. This study aimed to determine the prevalence and characteristics of irregular antibodies in paediatric patients with haematological disorders at the National Institute of Hematology and Blood Transfusion (NIHBT). A total of 2663 paediatric patients with haematological disorders were screened for irregular antibodies using column agglutination technology. Positive samples underwent antibody identification. Associations between alloimmunization and clinical or transfusion-related factors were assessed using univariate analyses and multivariable logistic regression. The prevalence of irregular antibodies was 8.04% (95% confidence interval [CI]: 7.0-9.1). Among positive cases, 66.82% had a single antibody, most commonly anti-E (35.51%) and anti-Mia (14.02%). The most frequent antibody combination was anti-c and anti-E (13.08%). Factors significantly associated with antibody formation after adjustment included a higher number of transfused red cell units (57.65 vs. 44.53 units, p = 0.000), absence of phenotype-matched transfusions (p = 0.017), non-Kinh ethnicity (p = 0.0003) and a diagnosis of thalassaemia (p = 0.0013). A relatively high prevalence of irregular red cell alloantibodies was observed in paediatric patients, predominantly involving antibodies of the Rh blood group system and anti-Miᵃ. These findings support the relevance of targeted antigen matching in settings where fully phenotype-matched red blood cells are not consistently available.
Donated plasma is required for the manufacture of plasma medicines, which are essential for prophylaxis and patient treatment. Because of social, geopolitical or economic challenges, this important raw material can become at risk of supply interruption, leading to a lack of essential products for patients. The plasma supply chain depends on the willingness of individuals to donate. To increase the number of donors and donations, collection institutes use various information, recruitment and retention strategies to increase individual willingness to repeatedly donate plasma. In this short report, we provide an overview of current (plasma) donor recruitment and retention strategies across 17 European countries. An online survey, consisting of questions on information, communication, recruitment and retention efforts, was sent to collection institutes via e-mail. Between July and October 2023, 17 respondents replied to the survey on behalf of their organization. The majority of organizations (10) were governmental or state public bodies, while 5 were non-governmental or non-state not-for-profit organizations and 2 were hospital-based. All 17 organizations collect whole blood, 16 collect platelets, 12 collect plasma and 7 collect combinations of blood products. The majority (nine) indicated they do not collect enough to meet national demand and are thus (partially) dependent on plasma from other countries. While blood establishments currently employ a broad portfolio of strategies, varying and targeted content and different media and channels to reach their audiences, there is very limited data and knowledge available on the evaluation, effectiveness and impact of these strategies.
Daratumumab, a therapeutic human anti-CD38 monoclonal antibody, improves multiple myeloma outcomes but interferes with pre-transfusion testing by binding CD38 on reagent red blood cells (RBCs), potentially masking clinically significant alloantibodies. This study aimed to evaluate the effectiveness of a novel high-affinity anti-idiotypic anti-daratumumab reagent in neutralizing daratumumab interference while preserving RBC alloantibody detection and ensuring compatibility with routine transfusion laboratory workflows. A non-interventional, multicentre study across 28 transfusion laboratories in 15 countries evaluated a novel anti-idiotypic anti-daratumumab reagent (DaraClear). In total, 443 daratumumab-containing plasma samples and 197 RBC alloantibody-containing samples were tested. All samples were initially tested at 10% (v/v), with stepwise escalation to 20% and 30% only if neutralization was incomplete. Neutralization efficiency, antibody detection, cross-match resolution and workflow integration were assessed, alongside comparisons with dithiothreitol (DTT), papain, trypsin and DaraEx. Daratumumab interference was neutralized in 99.5% of samples, with 86.2% resolved using the 10% protocol. Detection of 190/197 RBC antibodies (96.4%) was preserved, including weak/low-titre antibodies. Neutralization was superior to DTT (93.3%), papain/trypsin (84.9%) and DaraEx (68.4%; all p < 0.0001). Titration studies confirmed efficacy across various ranges of daratumumab titres. The reagent integrated seamlessly into workflows, remained stable over time and avoided RBC modification. Daratumumab interference was efficiently neutralized while preserving alloantibody detection. The robust performance and workflow compatibility provide a practical solution for pre-transfusion testing in daratumumab-treated patients, supporting safe and timely transfusions with reduced laboratory burden.
No established standards currently exist regarding the optimal interval for repeating antibody identification. Considering both transfusion safety and resource constraints, this study aimed to investigate the feasibility of extending the interval between antibody identification tests in a high-volume transfusion setting. We retrospectively reviewed 153,526 records over a 7-year period in which antibody identification was repeated at 7-day intervals under current practice. Cases with autoantibodies, non-specific antibodies, drug-related antibodies, passive anti-D from Rhesus immunoglobulin (RhIG) or unidentified antibodies were excluded. Time intervals to newly detected antibodies (0-7, 8-14, 15-21 and 22-30 days) were analysed in transfused patients with at least one pre-existing antibody. A total of 5806 antibodies were detected from 4835 patients (3.15%). Of these, 217 antibodies were detected in 155 patients (3.21%) who were known to previously possess at least one antibody. Antibody development was most frequently detected at 8-14 days post transfusion (16 cases, 35.56%), followed by 22-30 days (14 cases, 31.11%), 15-21 days (10 cases, 22.22%) and 0-7 days (5 cases, 11.11%). The median time to new antibody detection was 15.5 days (interquartile range, 10-26 days). This study proposes an optimal interval for antibody identification in settings with a high prevalence of transfusion-dependent patients and resource constraints. A 14-day interval has the potential to reduce personnel workload and costs while maintaining transfusion safety.