Vox Sanguinis最新文献

Background and objectives: Iron deficiency (ID), with or without anaemia, affects over 1 billion people globally. Early detection is essential, but current diagnostic tools may be costly, logistically complex and not widely accessible. This study evaluates low haemoglobin density percentage (LHD%), derived from mean corpuscular haemoglobin concentration (MCHC) in routine complete blood counts (CBCs), as a no-added-cost, accessible alternative for ID screening.

Materials and methods: We retrospectively analysed 3526 adult patient records (January-April 2025) from a single-centre institution, including those with iron panel and CBC performed within 24 h. Patients were categorized as Normal, ID, ID anaemia (IDA) or anaemia without ID (AwoID). LHD% was calculated and assessed across groups using receiver operating characteristic (ROC) curve analyses for cutoff determinations.

Results: Median LHD% increased progressively from the Normal group (2.99%) to the IDA group (6.71%). ROC analysis showed modest but acceptable diagnostic performance: area under the curve (AUC) was 0.677 overall, 0.687 in non-anaemic and 0.684 in anaemic subjects. Specific LHD% cutoffs varied by context: >4.48% for general screening (61% sensitivity, 67% specificity), >7.02% for donor screening (95% specificity) and >3.74% for anaemia workup (75% sensitivity).

Conclusion: LHD% shows potential as a context-specific, no-added-cost screening tool for ID using existing CBC data. While its diagnostic performance is modest, its scalability and accessibility could support broader public health screening efforts. Further prospective validation is recommended.

Background and objectives: The demand for intravenous immunoglobulin (IVIG) is increasing, but supply is limited. Some residual protein contaminants such as prekallikrein activator (PKA) and immunoglobulin A (IgA) can cause severe adverse effects, necessitating a more efficient purification process with high recovery and fewer impurities.

Materials and methods: We used IVIG intermediate from caprylic acid precipitation as the starting material. Diatomite adsorption and two-step anion exchange chromatography (AEX) were employed to remove PKA, Factor XII, prekallikrein and kallikrein. Three resins for the second-step flow-through mode AEX were evaluated, and the loading conditions were optimized by Design of Experiments (DoE) and high-throughput screening experiments to better remove IgA and immunoglobulin M (IgM). Pilot-scale experiments validated the feasibility of the optimized process.

Results: Diatomite adsorption (300 g/kg, 1 h) and two-step AEX could remove PKA, Factor XII, prekallikrein and kallikrein to below the limit of detection. The best AEX resin and optimal loading condition (pH 6.0 with 3.0 mS/cm conductivity) to remove IgA and IgM were obtained. As a result, IgA and IgM could be reduced to 3.83 and 10.70 μg/mL, respectively, with the immunoglobulin G (IgG) recovery over 86.9%. The 800-L pilot-scale results demonstrated successful process scale-up, achieving robust IgG recovery and effective impurity removal for IVIG production.

Conclusion: The combination of diatomite absorption and optimized two-step AEX resulted in IVIG preparation with enhanced purity and high recovery.

Three technologies are currently under active development for pathogen inactivation of red cell concentrates or whole blood (WB): the Intercept technology using S-303 as an inactivating chemical; the Theraflex technology using UV-C illumination; and the Mirasol technology using riboflavin and UV light. For the UV-C technology, no in vivo data are available. For the other two technologies, recovery, survival and life span of the treated red blood cells (RBCs) are shortened but are within objective requirements, including a 24-h recovery >75%. S-303-treated RBCs were transfused in various patient groups and, so far, showed no relevant differences in the clinical endpoints. In early studies, S-303-reactive antibodies were observed, which prompted changes in the inactivation process, and no further antibody formation was seen. The one published study with the riboflavin/UV procedure showed good effectiveness of treated WB, with haemoglobin increment similar to that of untreated WB. When considering potential implementation of pathogen inactivation strategies, a balance should be struck between microbiological safety, component quality and cost. None of the current technologies is in a stage for large-scale blood bank application, either because of limited availability of evidence of satisfactory in vitro quality data or because of the ongoing requirement of clinical trials in a broad spectrum of patients.

Background and objectives: The para-Bombay phenotype is characterized by the lack of ABH antigens on red blood cells, but ABH substances can be found in saliva. In this study, we report a novel FUT1 allele responsible for a para-Bombay phenotype in a pregnant woman.

Materials and methods: ABO, H and Lewis phenotypes and the secretor status were studied in blood and saliva samples. ABO, FUT1 and FUT2 genes were sequenced. Haplotypes were determined by clone sequencing. The structural impact of the new FUT1 variant was assessed using ChimeraX and AlphaFold software.

Results: Serological tests revealed a para-Bombay phenotype. Sequencing studies suggested the presence of the ABO*A1.01 and ABO*O.01.01 reference alleles. The molecular analysis of FUT1 revealed the presence of the FUT1*01W.31 allele and the novel c.521T>C variant responsible for the p.Phe174Ser change. FUT2 study showed the homozygous substitution c.390C>T. The analysis of the AlphaFold model of α2FucT1 predicted that Phe174 is a structural residue located deep inside the protein's hydrophobic core.

Conclusion: We identified the FUT1*01W.31 allele in compound heterozygosity with a novel allele carrying the missense substitution c.521T>C as responsible for the para-Bombay phenotype. In silico studies support that the p.Phe174Ser gives rise to a weak FUT1 variant.

Background and objectives: On-site donor deferral for low haemoglobin (Hb) levels poses significant challenges for blood establishments globally, leading to material wastage and consumption of valuable staff and donor time. Traditionally, donors are deferred based on a single visit's Hb measurement, without considering previous Hb levels and measurement variability. This study aims to quantify, in different settings, the potential impact of an alternative deferral algorithm based on historical mean Hb levels.

Materials and methods: We retrospectively reassessed donor eligibility in 20,430,816 donations and deferrals in Australia, Belgium, Finland, France, the Netherlands, South Africa and the United States using an algorithm that considers a repeat donor eligible as long as their historical mean Hb is above the deferral threshold and deviations from the mean are consistent with anticipated measurement variability. We quantified the potential impact of the alternative algorithm by calculating the change in donations and deferrals.

Results: Across countries, the alternative algorithm may reduce low Hb deferrals between 30% and 70%. Additionally, in every country, a small proportion of current donors (~1%) donate who exhibit consistent low Hb levels. Balancing new deferrals and donations, the estimated net increase in donations across countries ranges between 0.7% and 3.3%.

Conclusion: The alternative deferral algorithm based on mean Hb levels is a first step towards a more comprehensive assessment of Hb levels to determine donor eligibility. Further research is needed to refine the algorithm, to determine its long-term impact, to improve the model with information related to iron stores and recovery and to address the impact on donor safety.

Background and objectives: Suboptimal use of RhD-negative red blood cells (RBCs) can lead to reduced inventories of this scarce resource. Prevention of D-alloimmunization is particularly important for RhD-negative females of childbearing potential (FCPs). The utilization of RBCs in the Region of Southern Denmark was analysed to elucidate opportunities for conserving RhD-negative RBCs.

Materials and methods: RBC transfusions from 1 January 2020 to 31 December 2024 were identified using the South Danish Transfusion Service's laboratory and inventory IT systems. RhD-typing results, including the time when the patient's RhD type became known, were used to identify whether a historical or current RhD type was available at the time of RBC transfusion. Transfusions were grouped into 72-h 'transfusion episodes', and the achievement of the RBC critical administration threshold (CAT; 3 RBC units/h) was noted.

Results: There were 30,564 recipients of 162,778 RBC units. Of these units, 36,483 (22%) units were RhD-negative, out of which 22,922 (63%) were crossmatched (i.e., sufficient time was available to demonstrate compatibility with recipient plasma) and issued to RhD-negative non-FCPs; 1934 (5%) units were uncrossmatched and urgently transfused to 1409 patients who were historically known to be RhD-positive, and 934 (3%) units were transfused to 303 non-FCPs without a current or historical RhD type. In RhD-negative patients who reached CAT, 1440 of 36,483 (4%) RhD-negative RBC units were transfused after they had reached CAT.

Conclusion: Many of the RhD-negative RBC units were issued to recipients who were not RhD-negative FCPs, those known to be RhD-positive and those requiring massive transfusion, suggesting strategies for resource conservation.

Background and objectives: The role of viscoelastic haemostatic assays (VHAs) versus conventional coagulation tests (CCTs) in chronic liver disease (CLD) in the emergency department (ED) is undefined. We aimed to characterize VHA profiles and concordance with CCT.

Materials and methods: Patients with CLD presenting to EDs (January 2016-August 2023) were included. Post-transfusion results were excluded. VHA was categorized as hypo/normo/hypercoagulable using manufacturer ranges. CCT-coagulopathy was defined as international normalized ratio (INR) >1.5, platelets <50 × 10⁹/L or fibrinogen <1.0 g/L.

Results: VHA use increased over time (incidence rate ratio [IRR] 1.23, 95% confidence interval [CI]: 1.19-1.28; p < 0.001). Of 438 patients, 397 underwent rotational thromboelastometry (ROTEM) and 41 thromboelastography (TEG). ROTEM showed hypocoagulability in 275 patients (69%), normocoagulability in 84 (21%), hypercoagulability in 18 (5%) and mixed profiles in 14 (4%). Deficits were fibrinogen deficiency in 220 patients (55%), factor deficiency in 148 (37%), hyperfibrinolysis in 42 (11%) and platelet deficiency in 33 (8%). TEG showed hypocoagulability in 22 (54%), normocoagulability in 13 (32%), hypercoagulability in 3 (7%) and mixed profiles in 3 (7%). Deficits included fibrinogen deficiency in 19 patients (46%), factor deficiency in 6 (15%), hyperfibrinolysis in 5 (12%) and platelet deficiency in 3 (7%). In 120 VHA-CCT paired results, fibrinogen deficiency was detected by both in 18%, VHA alone 26%, CCT alone 2%; platelet deficiency by both 5%, VHA alone 5%, CCT alone 5%; factor deficiency by both 22%, VHA alone 3% and CCT alone 42%.

Conclusion: Hypocoagulability from reduced fibrin-based clot strength was predominant. Marked discordance between VHA and CCT was observed in coagulation factor deficiency. CLD-specific thresholds are required to guide transfusion.

In 2025, the Parasitology Subgroup of the International Society of Blood Transfusion (ISBT) Transfusion-Transmitted Infectious Diseases (TTID) Working Party (WP) transitioned into the Emerging Pathogens and Parasitology (EPP) Subgroup (referred to here as the EPP). This followed recognition that the parasitology subgroup's relevance was limited in scope given the small number of transfusion-transmissible parasites that still lacked effective mitigation. The EPP was proposed to address themes that are not adequately covered by existent subgroups of the TTID WP. In addition to maintaining a focus on transfusion-transmissible parasitic infections, a major objective of the EPP is horizon scanning for emerging pathogens. Horizon scanning refers to a systematic and proactive approach of information gathering and evaluation to identify early-and often subtle-signals of possible threats, which in this case pertain to blood safety. The EPP will characterize those risks to guide decision making and preparedness, pertaining to the safety and sufficiency of the blood supply. We describe the scope, structure and functioning of the EPP, within the broader TTID WP. We include examples of projects that may be pursued and outputs from horizon scanning a contemporary emerging pathogen. This collectively highlights the strategic relevance and objectives of the EPP.

Background and objectives: Tranexamic acid (TXA) as an adjunct to prophylactic platelet transfusion is sometimes used to prevent bleeding in patients with malignancies experiencing chemotherapy-induced thrombocytopenia. However, there is little biological evidence in support. This pilot exploratory study aimed to evaluate the haemostatic efficacy of TXA before and after platelet transfusion versus platelet transfusion alone in patients with haematological malignancies experiencing chemotherapy-induced thrombocytopenia.

Materials and methods: Rotational thromboelastometry (ROTEM; EXTEM, tissue plasminogen activator [tPA]-EXTEM and FIBTEM) was used to assess the haemostatic effect of these treatments.

Results: Eighteen patients were randomized to receive platelet transfusion and either 3 or 1.5 g of TXA per day or to be observed. At enrolment, ROTEM parameters were similar across groups. TXA alone did not affect EXTEM clot formation time (CFT) or maximum clot firmness (MCF). A trend towards increased EXTEM CFT and MCF values 2 h after platelet transfusion was observed. The effect of TXA was witnessed by the increase in tPA-EXTEM lysis index at 60 min (LI60). In the observation group, tPA-EXTEM LI60 also significantly increased after platelet transfusion. The World Health Organization (WHO) rates for grade ≥2 bleeding and the median number of platelet transfusions were similar across all groups.

Conclusion: Platelet transfusion as well as TXA decreased fibrinolysis for this patient population. This could be explained by the plasminogen activator inhibitor 1 contained in platelets. Future research should explore other alternative treatments and the utility of viscoelastometric testing to guide platelet transfusions, particularly in cases of bleeding or platelet transfusion refractoriness.