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Abstract Fibrinogen concentrate (FC) for acquired hypofibrinogenemia associated with critical obstetrical hemorrhage (COH) was covered by public medical insurance in September 2021 in Japan. We aimed to investigate changes in the policy of FC use and its effect on COH after insurance coverage. A primary survey covering September 2020 to August 2021 and a secondary survey covering September 2021 to August 2022 were conducted at 428 higher-level medical facilities. We investigated the policy of FC use in transfusion strategy and the maternal outcomes in COH. Among the hospitals that responded to both surveys, the number of facilities that use FC increased from 51.5 (101/196) to 78.6% (154/196) (P

Background: The current best practices allow for the red blood cells (RBCs) to be stored for prolonged periods in blood banks worldwide. However, due to the individual‐related variability in donated blood and RBCs continual degradation within transfusion bags, the quality of stored blood varies considerably. There is currently no method for assessing the blood product quality without compromising the sterility of the unit. This study demonstrates the feasibility of monitoring storage lesion of RBCs in situ while maintaining sterility using an optical approach. Study design and methods: A handheld spatially offset Raman spectroscopy (RS) device was employed to non‐invasively monitor hemolysis and metabolic changes in 12 red cell concentrate (RCC) units within standard sealed transfusion bags over 7 weeks of cold storage. The donated blood was analyzed in parallel by biochemical (chemical analysis, spectrophotometry, hematology analysis) and RS measurements, which were then correlated through multisource correlation analysis. Results: Raman bands of lactate (857 cm−1), glucose (787 cm−1), and hemolysis (1003 cm−1) were found to correlate strongly with bioanalytical data over the length of storage, with correlation values 0.98 (95% confidence interval [CI]: 0.86–1.00; p =.0001), 0.95 (95% CI: 0.71–0.99; p =.0008) and 0.97 (95% CI: 0.79–1.00; p =.0004) respectively. Discussion: This study demonstrates the potential of collecting information on the clinical quality of blood units without breaching the sterility using Raman technology. This could significantly benefit quality control of RCC units, patient safety and inventory management in blood banks and hospitals. [ABSTRACT FROM AUTHOR]

Objective: Unexpectedly wide distribution (90%) of hemoglobin oxygen saturation (sO2) within red cell concentrates (RCCs) has recently been observed. Causes of such variability are not yet completely explained whereas the roles of oxygen and oxidative lesions during the storage of RCCs are known. The objectives of the present study are to characterize sO2 distribution in RCCs produced in a Swiss blood center and to investigate the influence of processing and donors’ characteristics.Methods: The level of sO2 was measured in 1701 leukocyte-depleted RCCs derived from whole blood donations in both top–bottom (TB; component filtered, SAGM) and top–top (TT; whole blood filtration, PAGGSM) RCCs. The sO2 value was measured non-invasively through the PVC bag prior to storage by resonance Raman spectroscopy. Gender, age, blood type, hemoglobin level, and living altitude of donors, as well as process method and time-to-process were recorded.Results: Overall, the sO2 exhibited a wide non-Gaussian distribution with a mean of 51.2 ± 18.5%. Use of top-top kits resulted in a 16% higher sO2 (P < 0.0001) than with top-bottom ones. Waiting time before processing only had a modest impact, but the blood processing itself reduced the sO2 by almost 12% (P < 0.0001). sO2 was also significantly affected by some donors’ characteristics. RCCs from men exhibited 25% higher sO2 (P < 0.0001) than those donated by women. Multivariate analysis revealed that the apparent correlation observed with hemoglobin level and age was actually due to multicollinearity with the sex variable. Finally, we noticed no significant differences across blood type but found that altitude of residence was associated with the sO2 (i.e., higher in higher living place).Conclusion: These data confirm wide sO2 distribution in RCCs reported recently. The sO2 was impacted by the processing and also by donors’ characteristics such as the gender and the living altitude, but not by the hemoglobin level, blood group and donor age. This study provides new hints on the factors influencing red blood cells storage lesions, since they are known to be related to O2 content within the bags, giving clues to better process and to better store RCCs and therefore potentially improve the efficacy of transfusion.

Objective: Unexpectedly wide distribution (<10 to >90%) of hemoglobin oxygen saturation (sO2) within red cell concentrates (RCCs) has recently been observed. Causes of such variability are not yet completely explained whereas the roles of oxygen and oxidative lesions during the storage of RCCs are known. The objectives of the present study are to characterize sO2 distribution in RCCs produced in a Swiss blood center and to investigate the influence of processing and donors' characteristics. Methods: The level of sO2 was measured in 1701 leukocyte-depleted RCCs derived from whole blood donations in both top–bottom (TB; component filtered, SAGM) and top–top (TT; whole blood filtration, PAGGSM) RCCs. The sO2 value was measured non-invasively through the PVC bag prior to storage by resonance Raman spectroscopy. Gender, age, blood type, hemoglobin level, and living altitude of donors, as well as process method and time-to-process were recorded. Results: Overall, the sO2 exhibited a wide non-Gaussian distribution with a mean of 51.2 ± 18.5%. Use of top-top kits resulted in a 16% higher sO2 (P < 0.0001) than with top-bottom ones. Waiting time before processing only had a modest impact, but the blood processing itself reduced the sO2 by almost 12% (P < 0.0001). sO2 was also significantly affected by some donors' characteristics. RCCs from men exhibited 25% higher sO2 (P < 0.0001) than those donated by women. Multivariate analysis revealed that the apparent correlation observed with hemoglobin level and age was actually due to multicollinearity with the sex variable. Finally, we noticed no significant differences across blood type but found that altitude of residence was associated with the sO2 (i.e., higher in higher living place). Conclusion: These data confirm wide sO2 distribution in RCCs reported recently. The sO2 was impacted by the processing and also by donors' characteristics such as the gender and the living altitude, but not by the hemoglobin level, blood group and donor age. This study provides new hints on the factors influencing red blood cells storage lesions, since they are known to be related to O2 content within the bags, giving clues to better process and to better store RCCs and therefore potentially improve the efficacy of transfusion. [ABSTRACT FROM AUTHOR]

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Quatre-vingt-dix millions de patients reçoivent une transfusion de globules rouges chaque année. Cette procédure nécessite une étape de stockage des globules rouges entre le don et la transfusion au receveur, permettant la réalisation de contrôles de qualité et une meilleure gestion des flux. Les nombreuses améliorations techniques des dernières décennies permettent aujourd'hui le stockage réfrigéré des concentrés érythrocytaires (CGR) pendant 42 jours avant utilisation. Ce stockage s'accompagne cependant d'altérations des globules rouges, collectivement nommés les « lésions » de stockage, dont l'amplitude augmente avec la durée de conservation et serait responsable de la clairance post-transfusionnelle précoce d'une partie des globules rouges transfusés (en moyenne 18 %), diminuant d'autant le rendement transfusionnel. L'impact de la durée de conservation sur la sécurité transfusionnelle a été largement débattu au cours des dernières années et, si l'innocuité de la prise en charge standard semble établie, la question de la sécurité des CGR après 35 jours de stockage est l'objet de controverses. En Europe, le seul critère de qualité des CGR est l'hémolyse à 42 jours qui ne doit pas dépasser 0,8 %, mais ce paramètre n'a pas été corrélé au rendement transfusionnel. De nouveaux marqueurs, notamment basés sur les modifications morphologiques liées au stockage, pourraient être mieux corrélés au rendement transfusionnel. Ninety million patients receive a red blood cell transfusion every year. This procedure requires to store red blood cells (RBC) between donation and transfusion to the recipient, to allow quality control and better flow management. Numerous technical improvements in recent decades now allow refrigerated storage of RBC concentrates for 42 days before use. During this 6-week-long period, a series of modifications that alter RBC have been described, collectively referred as the storage «lesion». These alterations increase with storage duration and is responsible for the early post-transfusion clearance of a portion of the transfused RBC (on average 18 %), reducing transfusion yield. The impact of storage duration on transfusion safety has been widely debated in recent years and, while the safety of standard care management seems to be established, the question of the safety of RBC stored for more than 35 days is still controversial. In Europe, the only quality criterion for RBC concentrates is hemolysis at 42 days, which should not exceed 0.8 %, but this parameter has not been correlated with transfusion efficacy. New markers, including storage-related morphological changes, may better correlate with transfusion yield. [ABSTRACT FROM AUTHOR]

Red blood cell (RBC) concentrates may be stored for up to 42 days before transfusion to a patient. During storage extracellular vesicles (EVs) develop and can be detected in significant amounts in RBC concentrates. The concentration of EVs is affected by component preparation methods, storage solutions, and inter-donor variation. Laboratory investigations have focused on the effect of EVs on in vitro assays of thrombin generation and immune responses. Assays for EVs in RBC concentrates are not standardized. The aims of this review are to describe the factors that determine the presence of erythrocyte-EVs in RBC concentrates, the current techniques used to characterize them, and the potential role of EV analysis as a quality control maker for RBC storage. • Extracellular vesicles are present in packed red blood cells. • Storage conditions promote the red blood cell derived extracellular vesicle release. • Red blood cell derived extracellular vesicle might modulate coagulation and immunity. [ABSTRACT FROM AUTHOR]

Background: Securing future blood supply is a major issue of transfusion safety. In this prospective 10-year longitudinal study we enrolled all blood donation services and hospitals of the federal state Mecklenburg-Western Pomerania. Methods and Results: From 2005 to 2015 (time period with major demographic effects), whole blood donation numbers declined by 18%. In male donors this paralleled the demographic change, while donation rates of females declined 12.4% more than expected from demography. In parallel, red cell transfusion rates/1,000 population decreased from 2005 to 2015 from 56 to 51 (-8.4%), primarily due to less transfusions in patients >60 years. However, the transfusion demand declined much less than blood donation numbers: -13.5% versus -18%, and the population >65 years (highest transfusion demand) will further increase. The key question is whether the decline in transfusion demand observed over the previous years will further continue, hereby compensating for reduced blood donation numbers due to the demographic change. The population structure of Mecklenburg-Western Pomerania reflects all Eastern German federal states, while the Western German federal states will reach similar ratios of age groups 18-64 years / ≥65 years about 10 years later. Conclusions: Regular monitoring of age- and sex-specific donation and transfusion data is urgently required to allow transfusion services strategic planning for securing future blood supply. [ABSTRACT FROM AUTHOR]

[Display omitted] • Storage-related changes were identified in Red Cell Concentrate using SORS. • MuSCA was employed to assess Raman data against parallel bioanalytical measurements. • Spectral markers strongly correlated with respective bioassays in RCC were revealed. • Our approach enabled direct quality monitoring of RCC within sealed transfusion bags. In this work we employ Spatially Offset Raman Spectroscopy (SORS) to non-invasively identify storage-related changes in red blood cell concentrate (RCC) in-situ within standard plastic transfusion bags. To validate the measurements, we set up a parallel study comparing both bioanalytical data (obtained by blood-gas analysis, hematology analysis and spectrophotometric assays), and Raman spectrometry data from the same blood samples. We then employ Multisource Correlation Analysis (MuSCA) to correlate the different types of data in RCC. Our analysis confirmed a strong correlation of glucose, methemoglobin and oxyhemoglobin with their respective bioassay values in RCC units. Finally, by combining MuSCA with k -means clustering, we assessed changes in all Raman wavenumbers during cold storage in both RCC Raman data from the current study and parallel RCC supernatant Raman data previously acquired from the same units. Direct RCC quality monitoring during storage, would help to establish a basis for improved inventory management of blood products in blood banks and hospitals based on analytical data. [ABSTRACT FROM AUTHOR]

Red blood cell concentrates (RCCs) are the major blood component transfused to patients. There is a great variability in patient response, depending on both the patient's blood volume and haemoglobin content in the RCC. Standardisation of transfusion practice is needed to improve the prediction of patient outcome. We hypothesise that labelling of RCCs with haemoglobin content will add possibilities for the standardisation of transfusion practice. Data from multiple international transfusion services regarding haemoglobin content and weight or volume of RCC were collected and analysed. We demonstrate a strong and highly significant correlation between haemoglobin content with both weight and volume of the RCCs. A linear regression model was used to assess these relationships, and it demonstrates how haemoglobin content can be estimated for different cell production processes. We recommend the use of weight or volume of the RCCs as the basis of estimating haemoglobin in the RCC and postulate that this can be used in future studies to explore the effects of a haemoglobin dose-based transfusion system. As the weight - and sometimes the volume - of the blood bag is easily accessible, in contrast to direct haemoglobin measurements from each individual unit, this method is feasible and simple. [ABSTRACT FROM AUTHOR]

Background and Objectives The German Armed Forces Blood Service in Koblenz supplies red blood cell concentrates (RBCs) to military and civilian institutions at home and to field hospitals during peacekeeping operations abroad. During long-distance transport, blood products can be exposed to extreme environmental conditions or inappropriate handling, which may compromise product quality. Materials and Methods Different active and passive cooling systems, cooling elements, packaging material and data loggers were examined in a climate chamber. A number of techniques for measuring temperature were investigated in order to preserve the blood products’ quality during transport, including some field tests with multiparametric data recording. Results Any kind of active cooling systems, conventional cooling elements and customary packaging material, as well as temperature-sensitive labels, minimum–maximum thermometers and intra-product measurement were found to be unsuitable for military requirement. The best results were obtained when the passively cooling RCB 25 transport box (Dometic) was used together with latent heat/cold storage elements (deltaT) and Junior data loggers (Escort). Conclusion The elaborated protocol allows temperatures to be maintained between 2 and 6°C as required by European guidelines for at least 36 h each and between 1 and 10°C as required by German guidelines for at least 48 or 64 h at ambient temperatures between −10 and 40°C. Preliminary results indicate that care must be taken concerning additional factors such as air pressure variation or vibration. [ABSTRACT FROM AUTHOR]

Background and Objectives The aim of this study was to investigate whether in-line filtration, using a polyester filter for the preparation of red cell concentrates (RCC) and plasma (PL), leads to an altered proportion of T and B lymphocytes in the fraction of residual white blood cells (WBC). Materials and Methods The capacity of Pall WBF-2 in-line filters to reduce the numbers of T and B lymphocytes from red blood cell concentrates (RCC) and plasma (PL) of 22 donations was investigated by three-colour flow cytometry (FC) using the Tritest-Trucount kit. T and B lymphocytes were identified using monoclonal antibodies (mAbs) against CD3, CD19 and CD45, conjugated with fluorescein isothiocyanate, phycoerythrin or peridinin chlorophyll protein-A, respectively. As the number of B cells was below the detection limit of the FC method, WBC of the respective blood components of healthy donors were concentrated 25-fold by Percoll density-gradient centrifugation. In this fraction the absolute numbers of T and B cells, as well as their ratio, were determined using the Attractor software, which provides a discrimination of rare cell counts from FC in relation to debris. Results The mean numbers, as well as minima and maxima of T and B lymphocytes per unit, were as follows. T cells in RCC: 4·51 × 103 (1·68 × 102 -4·09 × 104 ) and in PL: 1·35 × 103 (2·21–1·78 × 104 ); B cells in RCC: 2·33 × 103 (7·10 × 101 -9·15 × 103 ) and in PL: 2·33 × 102 (7·5 × 102 -2·8 × 103 ). T cells were retained, on average, at a higher level than B cells: 3·01 times higher in RCC and 1·01 times higher in PL. Conclusion After filtration, the ratio of T and B lymphocytes changed in RCC (1·95 : 1) compared with unfiltered blood, where it was... [ABSTRACT FROM AUTHOR]

Human red blood cell concentrate and platelet suspension are unstable preparations, therefore, they are not part of the international pharmaceutical market for biological and economic reasons. Consequently, they cannot be replaced by external sources. Human allogeneic erythrocyte and platelet preparations should therefore be considered as part of the common national wealth. The amount of transfused red blood cell concentrate has been declining in countries with advanced health systems in recent years. The changes were initially driven by the spread of the concept and practice of liberal and restrictive transfusion triggers. A complex, thoughtful system of perioperative blood utilization, the Patient Blood Management has later emerged, and a paradigm shift in the delivery of life-threatening perioperative bleeding has developed. At the same time, clinical practitioners are facing a new challenge of reducing willingness to donate blood worldwide. The rationalization of the use of human red blood cell concentrate and platelet suspension is essential in Hungary. As a health care measure, the currently rigidly earmarked financial resources available for allogeneic preparations and stable factor concentrates for the treatment of life-threatening haemorrhages need to be changed to be interoperable. The perioperative blood use could additionally be reduced by the widespread dissemination of the Patient Blood Management requiring complex coordinated educational interdisciplinary and logistical work. Orv Hetil. 2020; 161(37): 1545-1553.