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Background: In 2010, Denmark was the first country to implement a targeted routine antenatal anti-D prophylaxis (tRAADP) program, offering fetal RHD genotyping to all nonimmunized D negative pregnant women. The program represented a shift from only postnatal prophylaxis to a combined antenatal and postnatal prophylaxis. This study aimed to evaluate the clinical effect of tRAADP in Denmark.

Study design and methods: This nationwide registry-based cohort study included all D negative women who gave birth between 2004-2020, identified through the National Medical Birth Register and the Departments of Clinical Immunology in Denmark. The clinical effect of tRAADP was assessed by comparing the incidence of new D immunization between 2004-2009 (non-tRAADP-cohort) and 2011-2018 (tRAADP-cohort).

Results: A total of 282 women were D immunized during pregnancy between 2004-2009 (non-tRAADP-cohort), and 167 between 2011-2018 (tRAADP-cohort). The incidence of new D immunization decreased from 0.46% (95% CI 0.41-0.52) in the non-tRAADP-cohort to 0.22% (95% CI 0.19-0.25) in the tRAADP-cohort. The risk reduction was statistically significant p < 0.001. Notably, in the tRAADP cohort 0.1% (95% CI 0.08-0.12) of new D immunizations occurred before the time of antenatal prophylaxis.

Discussion: tRAADP significantly reduced the incidence of new D immunization by more than half, thus demonstrating the expected effect. However, even with full adherence to the current program, some women with early fetomaternal hemorrhage (FMH) were still at risk. Future studies may evaluate the impact of administering an additional tRAADP dose earlier in the second trimester to prevent this.

Background: Pathogen reduction (PR) may be used as an alternative to gamma or x-ray irradiation (I) to prevent transfusion associated graft versus host disease (TA-GVHD) if the pathogen reduction technology has been shown to inactivate residual lymphocytes. However, as I is considered the gold standard for reducing the risk of TA-GVHD, some centers continue to perform I in addition to PR. This study investigated the effect of concurrent pathogen reduction and irradiation (PR/I) on the biochemical characteristics of apheresis platelets at day 1, 5, and 7 of storage at room temperature.

Methods: We compared in vitro characteristics of apheresis platelets (PLTs), PR PLTs, I PLTs, and PR/I PLTs at storage day 1, 5, and 7. PLTs from six healthy volunteers were suspended in 65% PAS-3/35% plasma prior to splitting and treatment with PR, I, or PR/I. Parameters measured were: PLT loss, mean PLT volume (MPV), pH, glucose consumption, lactate production, CD62P, annexin V binding, PLT aggregation, mitochondrial membrane potential (MMP), and reactive oxygen species (ROS).

Results: PR/I PLTs did not show significant changes in measured parameters when compared to PR PLTs. However, when compared to control PLTs, PR and PR/I PLTs showed significant declines in PLT content, pH, MMP, aggregation and significant increases in MPV, CD62P, annexin V binding, and ROS production, mostly on day 7 of storage. Irradiation did not cause significant changes in measured parameters in comparison to control PLTs.

Conclusions/summary: While PR impacts PLTs' biochemical characteristics and function, irradiation of PR PLTs did not cause additional significant changes.

Background: Among the alleles of the ABO system, cisAB and B(A) are the most intriguing due to their ability to encode a glycosyltransferase that can synthesize both A and B antigens. This dual activity leads to the formation of the AB phenotype, even in the presence of the O allele; resolution is achieved by molecular analyses.

Case presentation and methods: We describe herein a Brazilian family in which the mother (M42.1) of group AB and the father (M42.2) of group O have two children of group AB (M42.3 and M42.4). Serological characterization involved ABO and H phenotyping tests and serial dilution of ABO monoclonal antibodies. Characterization of ABO genotypes and alleles were performed by PCR-RFLP and sequencing.

Results and discussion: In serological tests, red blood cells from M42.1, M42.3, and M42.4 showed an intermediate reactivity pattern between A₁B and A₂B. Molecular analyses revealed the presence of the ABO*O.01.01/O.01.01 genotype in M42.2 and the ABO*cisAB.05/O.01.01 genotype in M42.1, M42.3, and M42.4. The ABO*cisAB.05 allele encodes a glycosyltransferase able to synthesize A and B antigens in quantities sufficient to cause an agglutination reaction higher than that observed in A₂B phenotypes.

Conclusion: The combination of serological and molecular methods used in this study allowed us to determine the serological pattern, identify the ABO alleles, and explain the inheritance of the AB phenotype in this family.

Background: Platelets collected by the Trima Accel apheresis device (Terumo BCT) are automatically leukoreduced through a leukoreduction system (LRS) where WBCs are trapped in a conical-shaped LRS chamber. The content has been used as a valuable source of mononuclear cells for research purposes. In frequent, long-term platelet apheresis donors, lymphopenia has been associated with the use of LRS chambers, and implementation of plasma rinseback at the end of the procedure has been shown to mitigate the depletion of lymphocytes. In this report, the cellular content of the LRS chamber and remaining disposable was characterized with and without plasma rinseback.

Study design and methods: Trima disposable sets were obtained from apheresis platelet collections in 100% plasma or 35% plasma/65% PAS with or without plasma rinseback at the end of the collections. Cellular content was drained from the LRS chamber and the disposable and was characterized using a hematology analyzer and flow cytometer to establish total cell counts and proportions of RBC, platelet, and WBC subpopulations.

Results: LRS chambers contained approximately 10⁹ WBCs, with the majority being lymphocytes and monocytes. The addition of plasma rinseback significantly decreased the number of WBCs remaining in the disposable, thereby increasing the number of WBCs returned to the donor. However, rinseback did not impact the WBC content of the LRS chamber itself.

Conclusions: Blood Centers using the Trima Accel instrument may reduce lymphopenia in regular platelet donors by implementing plasma rinseback, while ensuring the cellular content of the LRS chamber intended for research purposes remains unaffected.

Background: While blood donation is generally safe, some donors experience vasovagal reactions (VVRs) that may lead to injury and reduce likelihood of future donation. Several risk factors for VVRs have been identified, but the consistency, magnitude, and validity of their associations have not been systematically evaluated. Therefore, this systematic review and meta-analysis synthesized evidence for VVR risk factors.

Methods: Database searches identified English-language studies published before February 2024 describing VVR risk factors in voluntary whole blood donors. Study characteristics, VVR and risk factor assessment methods, and effect sizes were extracted. Random-effects models pooled estimates across all studies and subgroups of geographical context, study quality, donation experience, and outcome severity. Inconsistently and infrequently reported risk factors were narratively synthesized.

Results: Totally 71 studies reporting a total of 19 million total donations were included. Female sex, new donor status, younger age, smaller blood volume, and lower blood pressure were positively associated with higher VVR risk. Donation-related fear, anxiety, and disgust were associated with higher VVR risk in narrative syntheses. Substantial between-study heterogeneity (I² > 90%) was observed for the majority of risk factors, while there was no clear evidence of subgroup variability and small study effects.

Conclusion: This systematic review and meta-analysis provides a comprehensive synthesis of risk factors for VVRs across wide-ranging blood service contexts and symptom severities, reinforcing evidence for previously identified factors. The heterogeneous associations of several risk factors motivate large-scale studies that enable comprehensive multivariable adjustment to evidence donor selection criteria and preventative intervention allocation.

Objectives: Identifying cardiac surgical patients at risk of requiring red blood cell (RBC) transfusion is crucial for optimizing their outcome. We critically appraised prognostic models preoperatively predicting perioperative exposure to RBC transfusion in adult cardiac surgery and summarized model performance.

Methods: Design: Systematic review and meta-analysis.

Study eligibility criteria: Studies developing and/or externally validating models preoperatively predicting perioperative RBC transfusion in adult cardiac surgery. Information sources MEDLINE, CENTRAL & CDSR, Embase, Transfusion Evidence Library, Web of Science, Scopus, ClinicalTrials.gov, and WHO ICTRP. Risk of bias and applicability: Quality of reporting was assessed with the Transparent Reporting of studies on prediction models for Individual Prognosis or Diagnosis adherence form, and risk of bias and applicability with the Prediction model Risk of Bias ASsessment Tool.

Synthesis methods: Random-effects meta-analyses of concordance-statistics and total observed:expected ratios for models externally validated ≥5 times.

Results: Nine model development, and 27 external validation studies were included. The average TRIPOD adherence score was 66.4% (range 44.1%-85.2%). All studies but 1 were rated high risk of bias. For TRUST and TRACK, the only models externally validated ≥5 times, summary c-statistics were 0.74 (95% CI: 0.65-0.84; 6 contributing studies) and 0.72 (95% CI: 0.68-0.75; 5 contributing studies) respectively, and summary total observed:expected ratios were 0.86 (95% CI: 0.71-1.05; 5 contributing studies) and 0.94 (95% CI: 0.74-1.19; 5 contributing studies), respectively. Considerable heterogeneity was observed in all meta-analyses.

Discussion: Future high quality external validation and model updating studies which strictly adhere to reporting guidelines, are warranted.

Background: The clinical significance of natural and treatment-emergent antibodies specific for amustaline/glutathione pathogen-reduced red blood cells (PRRBCs) is not known.

Study design and methods: A Phase 3, randomized clinical trial of PRRBCs (ReCePI) compared PRRBCs with conventional RBCs in cardiac or thoracic-aorta surgery. Subjects transfused during and for 7 days after surgery were screened for PRRBC-specific antibodies at baseline, 28 and 75 days post-surgery. Subjects with treatment-emergent antibodies were assessed for evidence of hemolysis. Cryopreserved subject RBC samples were assayed by flow cytometry for circulating PRRBCs using an acridine-specific (2S197-2M1) monoclonal antibody, and for human IgG-coated RBCs. RBC-surface acridine density was quantitated using a commercial calibrated phycoerythrin (PE)-bead panel.

Results: Five of 159 (3.1%) PRRBC and zero of 162 conventional RBC recipients developed treatment-emergent PRRBC-specific IgG, low titer antibodies detected 26-80 days post-surgery after exposure to 1-3 PRRBC units, without clinical evidence of hemolysis. DAT and eluate were weak (w+) positive and PRRBC-specific in one subject. A monocyte monolayer assay (MMA) was non-reactive in the three subjects with an interpretable result. Flow cytometry demonstrated circulating PRRBCs in all five subjects expressing surface acridine concentrations at the limit of detection (approximately 150-301 PE molecules/RBC) compared with freshly transfused PRRBCs (approximately 7500 PE molecules/RBC). In some samples, loss of surface acridine expression could not be distinguished from clearance of the PRRBCs.

Discussion: Treatment-emergent PRRBC-specific antibodies with the characteristics of nonclinically significant antibodies were detected in five subjects transfused with PRRBCs. Flow cytometry demonstrated persistent circulating PRRBCs with minimal surface acridine expression. (www.

Clinicaltrials: gov Identifier NCT03459287).

Background: The Rh blood group system (ISBT004) is encoded by two homologous genes, RHD and RHCE. Polymorphism in these two genes gives rise to 56 antigens, which are highly immunogenic and clinically significant. This study extended previous work on the establishment of RHD allele specific reference sequences using next generation sequencing (NGS) with the Ion Personal Genome Machine (Ion PGM) to sequence the complete RHCE gene.

Study design and methods: Genomic DNA (gDNA) samples (n = 87) from blood donors of different serologically predicted genotypes including R₁R₁ (DCe/DCe), R₂R₂ (DcE/DcE), R₁R₂ (DCe/DcE), R₂R_Z (DcE/DCE), R₁r (DCe/dce), R₂r (DcE/dce), R₀r (Dce/dce), rr (dce/dce), r'r (dCe/dce), and r″r (dcE/dce) were used in this study. The RHCE gene was amplified through overlapping long range-polymerase chain reaction (LR-PCR) amplicons and then sequenced with the Ion PGM. Data were analyzed against the human genome reference sequence build hg38 and variants were called.

Results: Referen variant allel VS. In addition to the RHCE reference alleles, different exonic single nucleotide variants (SNVs) were detected that encode known RHCE variant alleles including RHCE*Ce.09, RHCE*ceAR, and RHCE*ceVS.03. Numerous intronic SNVs were detected and compared from samples with different Rh genotypes, to determine their link to a specific Rh haplotype. Based on the exonic and intronic changes detected in different RHCE alleles, three RHCE reference sequences were established and submitted to Genbank (one for the RHCE*Ce allele, one for the RHCE*cE allele, and one for the RHCE*ce allele).

Conclusion: Intronic SNVs may represent a novel alternative diagnostic approach to investigate known and novel variants of the RH genes and the prediction of Rh haplotype.

Background: U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER-regulated products. Improved hemovigilance of platelet transfusions provides exposure data for future outcome studies and can identify opportunities to improve management of the limited platelet supply.

Methods: Platelet utilization in three hospital networks (2012-2018) is summarized from data obtained using Information Standard for Blood and Transplant (ISBT) 128 platelet codes. Transfusion episodes, the number of units transfused, and component characteristics are described.

Results: Most platelet-transfused patients (range 59.6%-62.2% across study years for all sites) received platelets once per year and used a small proportion of the total platelets transfused per year (range 18.4%-22.5%). In contrast, a minority of patients were transfused 12 or more times in a given study year (range 4.4%-6.3%) and used a plurality of transfused platelets (range 32.2%-44.4%) per year. The overall ratio of platelets transfused to the number of patients receiving any platelet transfusion was stable over the study period (range 3.9-4.5 platelets/patient) and similar among participating data sources. For all data sources, most transfusion episodes (78%) involved one component per transfusion episode.

Conclusion: ISBT 128 coding in the BEST Initiative was used to capture platelet transfusion events, component modifications, and characterize aspects of platelet use patterns. These data can be leveraged to identify opportunities for improved management of the platelet supply and provide granular exposure information for future studies of transfusion-related adverse events.