Vox Sanguinis最新文献

Background and objectives: The European Union's ban on the use of di(2-ethylhexyl) phthalate (DEHP) in medical devices will take effect in 2030. DEHP is a plasticizer in polyvinyl chloride blood bags that helps stabilize the red blood cell membrane during hypothermic red blood cell concentrate (RBCC) storage. Recent studies have shown that RBCCs have acceptable in vitro quality after storage in DEHP-free containers (e.g., plasticized with di(2-ethylhexyl) terephthalate [DEHT] and stored in phosphate-adenine-glucose-guanosine-saline-mannitol [PAGGSM] additive solution). To complement quality data, in this study, we compared bacterial growth in RBCCs stored in either DEHT/PAGGSM or DEHP/saline-adenine-glucose-mannitol (SAGM).

Materials and methods: Paired ABO-matched whole blood units were collected into DEHT/PAGGSM sets, pooled and split into one DEHT/PAGGSM and one DEHP/SAGM bag set. RBCCs were produced using a top/bottom buffy coat process, tested for baseline in vitro quality and sterility, and spiked with Yersinia enterocolitica, Serratia liquefaciens and Listeria monocytogenes (~10² CFU/mL) and Cutibacterium acnes (~10³ CFU/mL) (N = 3). RBCCs were stored at 1-6°C for 43 days and sampled weekly for bacterial enumeration. Bacterial counts were compared between DEHP/SAGM and DEHT/PAGGSM RBCCs over 43 days of storage.

Results: For Y. enterocolitica, S. liquefaciens and C. acnes, no differences in survival/growth between DEHP/SAGM and DEHT/PAGGSM RBCCs were observed. Y. enterocolitica and S. liquefaciens grew to 10⁸-10⁹ CFU/mL by day 14, while C. acnes remained at 10³ CFU/mL until day 43. L. monocytogenes counts declined in DEHT/PAGGSM compared to DEHP/SAGM RBCC on days 0-7, but bacterial loads were similar (~10⁷ CFU/mL) in both bags by day 43.

Conclusion: These results suggest that the bacterial safety risk of RBCCs is not increased in DEHT/PAGGSM containers.

Background and objectives: Immune-mediated haemolysis caused by red blood cell (RBC) auto or alloantibodies depends on several factors, including antibody subclass. Immunoglobulin (Ig) IgG1 and IgG3 are more efficient at triggering phagocytosis and complement activation. This study evaluated whether IgG subclass determination can help predict the clinical relevance of RBC antibodies in different immunohaematological contexts.

Materials and methods: Blood donors and patients with IgG-positive direct antiglobulin tests (DATs) were included. IgG subclasses were determined using monospecific gel cards for IgG1/IgG3. The monocyte monolayer assay (MMA) assessed in vitro biological relevance. Antibody specificity was established by standard immunohaematological techniques. Statistical comparisons were performed using Chi-square, Fisher's exact and Mann-Whitney U tests.

Results: Among patients with IgG autoantibodies (n = 29), 51.7% had IgG1 or IgG3, versus 3.7% of donors (n = 27; p < 0.001). The presence of IgG1/IgG3 autoantibodies showed 93% positive predictive value (PPV) and 96.3% specificity for distinguishing patients from donors. IgG1/IgG3 autoantibodies were more frequently associated with positive MMA results (83.3% vs. 33.3%). Among RBC alloantibodies (n = 17), 64% were IgG1/IgG3, correlating with MMA positivity (sensitivity 78%; PPV 77%). Antibodies traditionally considered benign were often IgG1/IgG3 and MMA-positive.

Conclusion: IgG subclass determination provides diagnostic value beyond IgG quantification alone. In DAT-positive donors, not detecting IgG1/IgG3 is compatible with a low haemolysis risk and often obviates follow-up; when IgG1/IgG3 are detected, selective evaluation may be appropriate. For alloantibodies, subclass identification may help predict clinical relevance, especially in urgent transfusion settings when MMA is unavailable, supporting transfusion safety decisions and efficient resource use.

Background and objectives: Japan's geographical and climatic vulnerability to natural disasters, including earthquakes, tsunamis and typhoons, presents significant challenges to maintaining a stable blood supply during emergencies. This review synthesizes lessons learned from three major earthquakes-the 1995 Great Hanshin-Awaji, the 2011 Great East Japan and the 2016 Kumamoto earthquakes-to inform disaster preparedness and blood service resilience.

Materials and methods: Key measures implemented by the Japanese Red Cross Blood Services (JRCBS) were examined, with a focus on systemic challenges, disaster response protocols and technological innovations that enhanced service continuity during and after large-scale disasters.

Results: The implementation of the Wide-Area Management System (WAMS) in 2012 enabled centralized testing, processing and real-time national inventory management, facilitating efficient redistribution of blood products during crises. Communication disruptions due to reliance on traditional telephone and fax lines remain a challenge. A recently introduced web-based ordering system has improved operational reliability. Transport logistics are also vulnerable; contingency strategies involving maritime routes, helicopters and drones are being explored. A potential large-scale earthquake beneath the Tokyo Metropolitan Area underscores the urgency of enhancing coordination with hospitals and developing multi-modal transport plans. JRCBS operational continuity guidelines provide structured protocols to ensure rapid recovery if key facilities are incapacitated.

Conclusion: Japan's experience highlights the importance of integrated management systems, robust communication infrastructure and diversified transport options in maintaining blood supply during disasters. These strategies offer a model for enhancing blood service resilience in disaster-prone regions globally.

Background and objectives: Wikipedia has become a widely consulted source for health-related information, including transfusion medicine, by both healthcare professionals and the general public. However, the accuracy and completeness of transfusion-related content on this platform remain understudied. So, we aimed to systematically evaluate the current state and quality of transfusion medicine-related content available on Wikipedia.

Materials and methods: The Wikipedia Subgroup of the Clinical Transfusion Working Party of the International Society of Blood Transfusion (ISBT) conducted a cross-sectional analysis of transfusion medicine-related Wikipedia articles up to 31 December 2024. Articles were identified using the search terms 'Transfusion', 'Blood Components', 'Blood Groups' and related topics. Data extracted and analysed included article metadata, content metrics, visibility indicators and editorial activity.

Results: A total of 190 Wikipedia pages related to transfusion medicine were identified, with an additional 14 domain-specific webpages. The most common categories were blood groups (15.3%), blood components (13.7%) and clinical transfusion medicine (11.6%). Nearly 50% of pages were created between 2006 and 2010. Only 21.6% of pages were classified as complete, while 48.4% remained in the development phase.

Conclusion: This study uncovers significant gaps in transfusion medicine content on Wikipedia, with many articles found to be incomplete or poorly maintained. These findings present a clear opportunity for healthcare professionals, particularly members of the ISBT Clinical Transfusion Working Party's Wikipedia Subgroup, to enhance the quality, accuracy and accessibility of transfusion-related information through coordinated, collaborative editing efforts.

Background and objectives: The 21st edition of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guide recommends replacing pH measurement with glucose determination as a quality control (QC) parameter for platelet concentrates (PCs) stored in platelet additive solutions (PAS). However, simple, validated glucose measurement methods suitable for Blood Establishment (BE) laboratories are lacking. This study assessed the feasibility of using a point-of-care (POC) glucometer for glucose measurement in PAS-E-stored PCs.

Materials and methods: Thirty PCs suspended in PAS-E were analysed on days 2 and 6 of storage using a POC glucometer (Accu-Chek Instant®, Roche) and a reference laboratory autoanalyser (AU5800, Beckman Coulter®). Method comparison was performed using paired statistical testing, categorical analysis at low glucose concentrations and correlation analysis as a descriptive measure of association.

Results: Glucose levels measured by the glucometer and the autoanalyser were comparable on day 6. The mean difference was 2.2 ± 5.5 mg/dL on day 2 (p = 0.033) and 0.4 ± 2.6 mg/dL on day 6 (p = 0.415). Although a strong linear association was observed between methods (r = 0.988; p < 0.001), correlation was not interpreted as evidence of analytical agreement. Classification of samples below the clinically relevant threshold of 10 mg/dL (≈0.56 mmol/L) did not differ significantly between methods.

Conclusion: A POC provides reliable glucose measurements in PAS-E PCs, comparable to a standard autoanalyser. This simple, rapid and cost-effective approach may facilitate implementation of the new EDQM recommendation and improve QC efficiency in BE.

Background and objectives: Patients with haematological malignancies often require blood transfusion support. Multiple allogeneic blood transfusions may result in alloimmunization, complicating future transfusions. This study determined alloantibody prevalence, specificities and factors associated with the presence of red blood cell (RBC) alloantibodies among transfused patients with haematological malignancies at Mbarara Regional Referral Hospital (MRRH) and the Uganda Cancer Institute (UCI).

Materials and methods: This was a cross-sectional study among patients with haematological malignancies who had been multiply transfused and were seeking cancer care at MRRH and the UCI, in Uganda. Patient plasma was screened for the presence of RBC alloantibodies using haemagglutination testing with a 3-cell commercial reagent RBC and antibody identification with 11-cell antibody panels.

Results: A total of 427 patients with a median age of 36 (inter-quartile range: 26-56 years) were investigated. Twenty-five participants (5.9%) possessed RBC alloantibodies whose specificities were as follows: anti-C, two; anti-D, four; anti-E, six; anti-K, four; and anti-c, anti-Fy^a, anti-Jk^a, anti-Le^a and anti-M, one each. Four patients possessed pan-reactive antibodies. Patients with chronic cancer (adjusted odds ratio [AOR] = 2.62, 95% confidence interval [CI]: 1.16-7.21), leukaemia (AOR = 2.71, 95% CI: 1.81-4.03), human immunodeficiency virus (HIV) infection (AOR = 4.34, 95% CI: 1.69-5.11), antibiotic use (AOR = 5.08, 95% CI: 2.11-7.41) and a history of ≥5 transfusions were significantly associated with RBC alloimmunization (p ≤ 0.05).

Conclusion: RBC alloimmunization prevalence was 5.9% and associated with clinical and transfusion-related factors. Alloantibodies to Rh, Kell, MNS, Duffy, Kidd and Lewis blood group systems were detected, underscoring the need for improved pre-transfusion testing in Uganda.

Background and objectives: Glycophorin GYP(B-A-B) hybrid alleles encode a set of low-frequency antigens, including Mi^a. Such hybrids are predominantly found in East and Southeast Asians and demonstrate variation in frequency within that region. These antigens and their corresponding antibodies are clinically significant. We aimed to characterize the GYP(B-A-B) hybrid alleles among north-eastern Thai blood donors.

Materials and methods: Altogether, 1377 DNA samples from north-eastern Thai blood donors were genotyped for GYP(B-A-B) using high-resolution melting (HRM) assay. Samples exhibiting aberrant melting profiles were investigated by Sanger sequencing. The immunogenic potential of the Mi^a antigen across diverse populations was also assessed using the Giblett equation.

Results: Among the 1377 donors, 249 (18.08%) were identified as carrying GYP(B-A-B) hybrids. Of these, 17 samples (1.24%) were GYP*Mur homozygotes, 219 (15.90%) were GYP*Mur/GYPB heterozygotes, 12 (0.87%) were GYP*Thai/GYPB heterozygotes and one sample (0.07%) was a compound GYP*Mur/GYP*Thai heterozygote. Additionally, six single-nucleotide polymorphisms (SNPs) were identified in five donors with the wild-type GYPB/GYPB genotype. Furthermore, one sample carried two variants at positions c.136+743C>G and c.136+746C>T within intron 2. The Giblett equation calculation predicted a high immunogenic potential of Mi^a antigen with substantial variation across populations (1.269-10.468).

Conclusion: In this study, GYP*Mur was the predominant hybrid allele with a frequency of 254/2754 (9.22%). GYP(B-A-B) hybrid alleles show considerable heterogeneity and immunogenicity, with population-dependent differences driven by variations in antigen distribution and antibody prevalence. The use of our molecular approach may help identify compatible blood products for transfusion and prevent alloimmunization.

Background and objectives: Europe will ban di(2-ethylhexyl) phthalate (DEHP), used in blood bags, after 1 July 2030. This two-phase study assessed the in vitro quality and in vivo 24-h post-transfusion recovery (PTR) of whole blood-derived leukoreduced red cell concentrates (RCCs) collected and processed in 1,2-cyclohexane dicarboxylic acid diisononyl ester (DINCH)-plasticized sets and stored for 42 days in non-DEHP Erythromate-plasticized, a proprietary blend of DINCH and N-butyryl-tri-n-hexyl citrate (BTHC), disposable sets.

Materials and methods: In Phase 1, in vitro parameters of RCCs (n = 32) stored in non-DEHP sets containing phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) were compared with those of RCCs stored in DEHP sets containing saline-adenine-glucose-mannitol (SAGM) (n = 24). These parameters were assessed against the European Directorate for the Quality of Medicines & Health Care (EDQM) criteria. In Phase 2, PTR of 42-day autologous non-DEHP RCCs was evaluated using biotin-labelled methods in 24 healthy participants and compared against the EDQM and the US Food and Drug Administration (FDA) criteria.

Results: Phase 1 results showed that haemoglobin concentrations remained stable. Haemolysis in non-DEHP/PAGGSM disposable sets was below the EDQM limit (<0.8%) with a 95% confidence limit (CL) of 0.25% on Day 42 and was significantly lower (0.22% ± 0.11%) compared to DEHP/SAGM (0.31% ± 0.14%). In Phase 2, PTR exceeded the 75% threshold set by the EDQM and FDA in all infusions (lower CL: 88.3%), with a mean of 93.3% ± 6.7%.

Conclusion: RCCs stored in non-DEHP/PAGGSM disposable sets met the in vitro EDQM criteria for quality and in vivo EDQM and FDA criteria for transfusable RCCs, thereby providing a suitable alternative to current DEHP-plasticized disposable sets.

Trial registration: The clinical trial was registered at the World Health Organization-International Clinical Trials Registry Platform (ICTRP): NL-OMON56734, registration date 30 April 2024.

Background and objectives: Patient blood management (PBM) is a multidisciplinary approach aimed at reducing the use of blood products. It considers the patient's own blood as a valuable resource to preserve and seeks to avoid the routine use of transfusions to treat anaemia. PBM is primarily based on interventions implemented by anaesthesiologists, including preoperative anaemia correction, targeted administration of coagulation factors and tranexamic acid and strict adherence to transfusion protocols. However, the role of surgical approaches in this context deserves attention. Indeed, surgical innovations over the past two decades have significantly contributed to reducing transfusion requirements. This review will focus on this aspect of PBM.

Materials and methods: For this review, we performed a comprehensive search of the PubMed database related to PBM in surgery and also consulted other relevant databases.

Results: In the preoperative period, advances in diagnostic techniques, surgical indications and surgical access allow for two blood-sparing options: active surveillance or alternatives to surgery. In the intraoperative period, the development of minimally invasive approaches, the use of innovative haemostatic techniques, per surgery autologous transfusion (cell salvage) and the prevention of hypothermia contribute to the reduction of blood loss and, consequently, the need for transfusion. In the postoperative period, proactive patient management through careful monitoring and the application of enhanced recovery after surgery principles plays a major role in decreasing overall postoperative morbidity.

Conclusion: These innovations have significantly reduced the need for transfusion in surgical practice. They enhance patient safety by minimizing bleeding and transfusion-related risks.

Background and objectives: Plasma transfusion is indicated for patients with coagulopathy and active bleeding or those undergoing major surgery. Appropriate use is defined by an international normalized ratio (INR) >1.7 and a dose of 3-4 units for adults. However, audits in tertiary care settings consistently revealed high rates of inappropriate plasma use. At Niagara Health, audits across three community hospitals showed that 42% of plasma transfusions in hospitalized adults were inappropriate, largely due to limited understanding of proper indications. This misuse leads to resource wastage, higher costs and unnecessary patient exposure to transfusion-related risks. The aim of this project was to improve appropriate plasma transfusion rates among hospitalized adults in three Niagara region hospitals by 25% over a 12-month period.

Materials and methods: This non-randomized, interrupted time series quality improvement project followed the Model for Improvement (MFI) framework. Sequential Plan-Do-Study-Act cycles began in July 2024, with monthly monitoring of transfusion rates. Interventions included an awareness campaign, enhanced audit and feedback and implementation of an electronic transfusion order set in the electronic medical record (EMR).

Results: During the study, 253 plasma units were transfused. Median monthly appropriateness rates were 90% (INR >1.7), 89% (dose >2 units) and 78% (both criteria). Appropriateness improved, particularly in dosing. Out-of-guideline requests screened by technologists decreased by 15%, with no significant change in plasma or red cell use.

Conclusion: Electronic order sets, technologist screening, education and audit-feedback improved adherence to plasma transfusion guidelines without increasing workload or affecting other blood product use. These strategies may be scalable to other components.