Jay Bisht, Kriti Batni, Satyam Arora, Seema Dua, Nita Radhakrishnan
Background and objectives: Paediatric transfusion therapy is critical for managing haematological and genetic disorders. However, parental knowledge about transfusion risks, including transfusion-transmitted infections (TTIs) and adverse reactions, remains largely unexplored. This study assessed parental knowledge, attitudes and practices (KAP) regarding paediatric blood transfusions.
Materials and methods: A prospective cross-sectional study was conducted at a tertiary care children's hospital in India over 6 months. A structured questionnaire evaluated parental knowledge.
Results: Among 230 parents (51.7% mothers), 51.3% knew their child's ABO blood group and 76.1% correctly identified the required blood component. Awareness of TTIs screened in donated blood (25.9%) and leukoreduction (2%) was low. Parents of children on chronic transfusion therapy demonstrated significantly better knowledge (p = 0.001 for blood group, p < 0.001 for blood component). Education level strongly predicted transfusion-related knowledge: parents with high school education were 16.8 times more likely to know the blood group (odds ratio [OR] = 16.84, p < 0.001) and 10.4 times more likely to identify the correct blood component (OR = 10.44, p = 0.026).
Conclusion: Significant gaps exist in parental knowledge, particularly regarding TTIs and leukoreduction. Higher education and chronic transfusion exposure improve awareness. Graduate education was linked to a better understanding of TTIs (OR = 2.95, p = 0.038). Targeted education can enhance transfusion safety and the consent process.
背景和目的:儿科输血治疗是管理血液和遗传疾病的关键。然而,父母对输血风险的了解,包括输血传播感染(tti)和不良反应,在很大程度上仍然是未知的。本研究评估了父母对儿科输血的知识、态度和做法(KAP)。材料和方法:在印度一家三级保健儿童医院进行了为期6个月的前瞻性横断面研究。一个结构化的问卷评估父母的知识。结果:230名家长(51.7%为母亲)中,51.3%的家长知道自己孩子的ABO血型,76.1%的家长正确识别出所需的血液成分。捐献血液中tti筛查(25.9%)和白细胞减少(2%)的知晓率较低。接受慢性输血治疗的儿童家长对输血治疗的认知明显提高(p = 0.001)。结论:家长对输血治疗的认知存在显著差距,特别是在TTIs和白细胞减少方面。高等教育和长期输血可提高认识。研究生教育与更好地理解tti有关(OR = 2.95, p = 0.038)。有针对性的教育可以加强输血安全和同意程序。
{"title":"Parents' perception and knowledge regarding blood transfusion in a tertiary care paediatric centre in India.","authors":"Jay Bisht, Kriti Batni, Satyam Arora, Seema Dua, Nita Radhakrishnan","doi":"10.1111/vox.70159","DOIUrl":"https://doi.org/10.1111/vox.70159","url":null,"abstract":"<p><strong>Background and objectives: </strong>Paediatric transfusion therapy is critical for managing haematological and genetic disorders. However, parental knowledge about transfusion risks, including transfusion-transmitted infections (TTIs) and adverse reactions, remains largely unexplored. This study assessed parental knowledge, attitudes and practices (KAP) regarding paediatric blood transfusions.</p><p><strong>Materials and methods: </strong>A prospective cross-sectional study was conducted at a tertiary care children's hospital in India over 6 months. A structured questionnaire evaluated parental knowledge.</p><p><strong>Results: </strong>Among 230 parents (51.7% mothers), 51.3% knew their child's ABO blood group and 76.1% correctly identified the required blood component. Awareness of TTIs screened in donated blood (25.9%) and leukoreduction (2%) was low. Parents of children on chronic transfusion therapy demonstrated significantly better knowledge (p = 0.001 for blood group, p < 0.001 for blood component). Education level strongly predicted transfusion-related knowledge: parents with high school education were 16.8 times more likely to know the blood group (odds ratio [OR] = 16.84, p < 0.001) and 10.4 times more likely to identify the correct blood component (OR = 10.44, p = 0.026).</p><p><strong>Conclusion: </strong>Significant gaps exist in parental knowledge, particularly regarding TTIs and leukoreduction. Higher education and chronic transfusion exposure improve awareness. Graduate education was linked to a better understanding of TTIs (OR = 2.95, p = 0.038). Targeted education can enhance transfusion safety and the consent process.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145597630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tranexamic acid (TXA) is an essential life-saving medicine that prevents clot breakdown in patients who are haemorrhaging from trauma, childbirth, surgery and other causes. While TXA is inexpensive, it is not widely used, especially in low- and middle-income countries, which also experience challenges in the domains of blood collection, testing, storage and transfusion. TXA has been extensively studied for the treatment of traumatic, obstetric and surgical bleeding, and landmark trials have repeatedly demonstrated its safety, efficacy and life-saving potential, especially when given early (within 3 h of the inciting event). Among trauma patients with blunt and penetrating injuries as well as head trauma, TXA decreases the risk of mortality and is also cost effective. Among women with postpartum haemorrhage, TXA decreases the risk of death due to bleeding, and has been successfully implemented as part of a bundled response. Among surgical patients across sub-specialties, TXA decreases the risk of mortality and even decreases the need for blood product transfusion. Furthermore, these trials have shown that TXA does not increase the risk of adverse events such as thrombosis or seizure. We encourage the global community to shift its focus from further trials to the development of standardized implementation protocols, which have been shown to increase TXA use in both high- and low-resource settings. Expansion of TXA availability and use in global blood deserts will help bridge the gap for haemorrhaging patients who are at risk of death and disability from injury, childbirth or surgical bleeding.
{"title":"The critical role of tranexamic acid for bleeding patients.","authors":"Avery A Thompson, Sidharth Misra, Laith Ayasa, Nikathan Kumar, Quentin Eichbaum, Nakul Raykar","doi":"10.1111/vox.70156","DOIUrl":"https://doi.org/10.1111/vox.70156","url":null,"abstract":"<p><p>Tranexamic acid (TXA) is an essential life-saving medicine that prevents clot breakdown in patients who are haemorrhaging from trauma, childbirth, surgery and other causes. While TXA is inexpensive, it is not widely used, especially in low- and middle-income countries, which also experience challenges in the domains of blood collection, testing, storage and transfusion. TXA has been extensively studied for the treatment of traumatic, obstetric and surgical bleeding, and landmark trials have repeatedly demonstrated its safety, efficacy and life-saving potential, especially when given early (within 3 h of the inciting event). Among trauma patients with blunt and penetrating injuries as well as head trauma, TXA decreases the risk of mortality and is also cost effective. Among women with postpartum haemorrhage, TXA decreases the risk of death due to bleeding, and has been successfully implemented as part of a bundled response. Among surgical patients across sub-specialties, TXA decreases the risk of mortality and even decreases the need for blood product transfusion. Furthermore, these trials have shown that TXA does not increase the risk of adverse events such as thrombosis or seizure. We encourage the global community to shift its focus from further trials to the development of standardized implementation protocols, which have been shown to increase TXA use in both high- and low-resource settings. Expansion of TXA availability and use in global blood deserts will help bridge the gap for haemorrhaging patients who are at risk of death and disability from injury, childbirth or surgical bleeding.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145550937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and objectives: Artificial intelligence (AI) and big data are technologies with the potential to transform transfusion medicine (TM). This survey explored the scope of AI and big data use in TM across the Eastern Mediterranean and North Africa region.
Materials and methods: A survey was distributed among transfusion professionals to explore current use, perceived benefits and barriers to adopting AI and big data.
Results: Fifty respondents participated; the majority worked in national/regional transfusion services, and 58% worked in academic institutions. Only 24% reported using AI in daily TM practice, primarily for administrative tasks, education and research. Clinical applications were mainly in blood donor recruitment and management. Most used generative AI tools (92%) and were self-taught. Big data were employed in 36% of respondents' institutions, most often for inventory forecasting and optimizing blood product utilization. Most institutions used data based on laboratory information systems (89%), donor databases (72%) and electronic healthcare/patient records (67%). The main challenges and concerns regarding AI adoption were the lack of regulatory guidance, limited expertise, insufficient clinical validation of AI tools, implementation cost and ethical and privacy concerns. In terms of big data, the key barriers were insufficient expertise in data management and a lack of infrastructure for data storage.
Conclusion: AI and big data adoption in TM within the region remains limited. Major barriers include regulatory gaps, lack of expertise, cost constraints and infrastructure limitations. Strategic investment in regulatory frameworks, targeted training and technical resources is essential to facilitate safe and effective integration into transfusion practice.
{"title":"Use of artificial intelligence and big data in transfusion medicine: An exploratory assessment of status in the Eastern Mediterranean and North Africa region.","authors":"Arwa Z Al-Riyami, Suha Herjes","doi":"10.1111/vox.70145","DOIUrl":"https://doi.org/10.1111/vox.70145","url":null,"abstract":"<p><strong>Background and objectives: </strong>Artificial intelligence (AI) and big data are technologies with the potential to transform transfusion medicine (TM). This survey explored the scope of AI and big data use in TM across the Eastern Mediterranean and North Africa region.</p><p><strong>Materials and methods: </strong>A survey was distributed among transfusion professionals to explore current use, perceived benefits and barriers to adopting AI and big data.</p><p><strong>Results: </strong>Fifty respondents participated; the majority worked in national/regional transfusion services, and 58% worked in academic institutions. Only 24% reported using AI in daily TM practice, primarily for administrative tasks, education and research. Clinical applications were mainly in blood donor recruitment and management. Most used generative AI tools (92%) and were self-taught. Big data were employed in 36% of respondents' institutions, most often for inventory forecasting and optimizing blood product utilization. Most institutions used data based on laboratory information systems (89%), donor databases (72%) and electronic healthcare/patient records (67%). The main challenges and concerns regarding AI adoption were the lack of regulatory guidance, limited expertise, insufficient clinical validation of AI tools, implementation cost and ethical and privacy concerns. In terms of big data, the key barriers were insufficient expertise in data management and a lack of infrastructure for data storage.</p><p><strong>Conclusion: </strong>AI and big data adoption in TM within the region remains limited. Major barriers include regulatory gaps, lack of expertise, cost constraints and infrastructure limitations. Strategic investment in regulatory frameworks, targeted training and technical resources is essential to facilitate safe and effective integration into transfusion practice.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145453391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and objectives: Granulocyte transfusions may benefit patients with neutropaenia and life-threatening infections unresponsive to antimicrobial therapies. Current aphaeresis-based granulocyte concentrate (GC) production requires donor stimulation and hydroxyethyl starch (HES), which raises safety and supply concerns. This study assessed the feasibility and quality of GCs derived from pooling 10 residual leukocyte units (RLUs) processed via the Reveos automated blood processing system.
Materials and methods: Whole blood (WB) from 10 ABO-compatible donors was processed using the Reveos system to obtain 10 mL RLUs. A modified platelet pooling device enabled sterile pooling of RLUs with added plasma. The final product was irradiated and analysed on days 0, 1 and 2 post-irradiation. Parameters assessed included cell counts, sterility, biochemical properties, viability, surface markers (CD15, CD10, CD62L and CD11b) and neutrophil functions: chemotaxis, phagocytosis, oxidative burst and H₂O₂ release.
Results: All GCs (n = 10) met sterility criteria and contained a mean granulocyte dose of 0.95 ± 0.17 × 1010. Neutrophils were mature (CD15+CD10+) and remained viable on day 2. Functional assays demonstrated sustained phagocytic and respiratory activity up to 48 h post-processing, although chemotactic response and reactive oxygen species (ROS) production declined significantly from 24 h after processing (p < 0.05).
Conclusion: Pooling of Reveos-derived RLUs is a feasible, HES-free strategy to produce viable and functional GCs over 24 h from processing and irradiation. This approach provides a readily available alternative to aphaeresis products that could potentially enhance transfusion coordination.
背景和目的:粒细胞输注可能对中性粒细胞减少和对抗菌药物治疗无反应的危及生命的感染患者有益。目前基于分离的粒细胞浓缩物(GC)的生产需要供体刺激和羟乙基淀粉(HES),这引起了安全性和供应问题。本研究评估了通过revos自动血液处理系统处理的10个残留白细胞单位(rlu)提取gc的可行性和质量。材料和方法:采用revos系统处理10例abo相容供者的全血(WB),获得10 mL rlu。改良的血小板池化装置使rlu与添加的血浆无菌池化。最终产物在照射后第0、1和2天进行辐照和分析。评估的参数包括细胞计数、无菌性、生化特性、活力、表面标志物(CD15、CD10、CD62L和CD11b)和中性粒细胞功能:趋化性、吞噬、氧化破裂和H₂O₂释放。结果:所有GCs (n = 10)均符合不育标准,平均粒细胞剂量为0.95±0.17 × 1010。中性粒细胞成熟(CD15+CD10+),并在第2天保持活力。功能分析显示,处理后48小时内,rgc的吞噬和呼吸活性持续存在,但处理后24小时内,趋化反应和活性氧(ROS)的产生显著下降(p)。结论:在处理和照射后24小时内,将revos衍生的rlv池化是一种可行的、无hes的策略,可以产生有活力和功能的GCs。这种方法提供了一种易于获得的替代分离产品,可以潜在地加强输血协调。
{"title":"Production of viable and functional neutrophils in granulocyte concentrates with the Reveos automated system.","authors":"Sahra Fonseca, Marie-Claude Lampron, Isabelle Paré, Marie-Pierre Cayer, Mélissa Girard","doi":"10.1111/vox.70067","DOIUrl":"10.1111/vox.70067","url":null,"abstract":"<p><strong>Background and objectives: </strong>Granulocyte transfusions may benefit patients with neutropaenia and life-threatening infections unresponsive to antimicrobial therapies. Current aphaeresis-based granulocyte concentrate (GC) production requires donor stimulation and hydroxyethyl starch (HES), which raises safety and supply concerns. This study assessed the feasibility and quality of GCs derived from pooling 10 residual leukocyte units (RLUs) processed via the Reveos automated blood processing system.</p><p><strong>Materials and methods: </strong>Whole blood (WB) from 10 ABO-compatible donors was processed using the Reveos system to obtain 10 mL RLUs. A modified platelet pooling device enabled sterile pooling of RLUs with added plasma. The final product was irradiated and analysed on days 0, 1 and 2 post-irradiation. Parameters assessed included cell counts, sterility, biochemical properties, viability, surface markers (CD15, CD10, CD62L and CD11b) and neutrophil functions: chemotaxis, phagocytosis, oxidative burst and H₂O₂ release.</p><p><strong>Results: </strong>All GCs (n = 10) met sterility criteria and contained a mean granulocyte dose of 0.95 ± 0.17 × 10<sup>10</sup>. Neutrophils were mature (CD15<sup>+</sup>CD10<sup>+</sup>) and remained viable on day 2. Functional assays demonstrated sustained phagocytic and respiratory activity up to 48 h post-processing, although chemotactic response and reactive oxygen species (ROS) production declined significantly from 24 h after processing (p < 0.05).</p><p><strong>Conclusion: </strong>Pooling of Reveos-derived RLUs is a feasible, HES-free strategy to produce viable and functional GCs over 24 h from processing and irradiation. This approach provides a readily available alternative to aphaeresis products that could potentially enhance transfusion coordination.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1083-1092"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12602127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144555091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-07-31DOI: 10.1111/vox.70088
Thomas Bailey-Schmidt, Christine V Saunders, Chloë E George, Thomas G Scorer, Lynn M R McCallum, Tracey E Madgett
Background and objectives: Cryopreservation allows for storage of red blood cells (RBCs) beyond the standard 35-day period. Current glycerol-based methods are labour-intensive and scale-limited in application. Tricine has been identified as a potential alternative cryoprotectant (CPA), demonstrating efficacy in sheep RBC. This study aims to evaluate the biocompatibility and efficacy of tricine in human RBC cryopreservation.
Materials and methods: Human and sheep RBCs were exposed to varying concentrations of tricine (2.0-20.0% w/v) or glycerol (20.0-40.0% w/v). Biocompatibility was assessed via 24-h incubation at 4°C, while cryoprotective efficacy was evaluated following freezing in liquid nitrogen, storage at -80°C and thawing at 37°C. RBC recovery was assessed via spectrophotometric estimation of haemolysis.
Results: Tricine was biocompatible, with <1% haemolysis in both species. When frozen, tricine provided significant protection against cryoinjury in sheep RBC, with maximal recovery at 8.0% w/v (42.17% ± 10.96% of RBC recovered). However, tricine lacked cryopreservative efficacy in human RBC, with post-thaw recovery rates on par with those seen following unprotected freezing. Even at the highest performing concentration (10.0% w/v), human RBC recovery remained low (16.08% ± 2.96%), highlighting the ineffectiveness of tricine in preserving human RBC integrity. Further analyses revealed greater hydrophilicity in sheep haemoglobin, which potentially influences freezing tolerance.
Conclusion: Despite promising results within the ovine model, tricine lacks CPA efficacy for human RBC. Species differences in RBC physiology likely contribute to these discrepancies. These findings emphasize the need for rigorous model selection in cryopreservation research and further investigation into CPA mechanisms.
{"title":"Exploring tricine as a novel red cell cryopreservative: Lessons and future directions.","authors":"Thomas Bailey-Schmidt, Christine V Saunders, Chloë E George, Thomas G Scorer, Lynn M R McCallum, Tracey E Madgett","doi":"10.1111/vox.70088","DOIUrl":"10.1111/vox.70088","url":null,"abstract":"<p><strong>Background and objectives: </strong>Cryopreservation allows for storage of red blood cells (RBCs) beyond the standard 35-day period. Current glycerol-based methods are labour-intensive and scale-limited in application. Tricine has been identified as a potential alternative cryoprotectant (CPA), demonstrating efficacy in sheep RBC. This study aims to evaluate the biocompatibility and efficacy of tricine in human RBC cryopreservation.</p><p><strong>Materials and methods: </strong>Human and sheep RBCs were exposed to varying concentrations of tricine (2.0-20.0% w/v) or glycerol (20.0-40.0% w/v). Biocompatibility was assessed via 24-h incubation at 4°C, while cryoprotective efficacy was evaluated following freezing in liquid nitrogen, storage at -80°C and thawing at 37°C. RBC recovery was assessed via spectrophotometric estimation of haemolysis.</p><p><strong>Results: </strong>Tricine was biocompatible, with <1% haemolysis in both species. When frozen, tricine provided significant protection against cryoinjury in sheep RBC, with maximal recovery at 8.0% w/v (42.17% ± 10.96% of RBC recovered). However, tricine lacked cryopreservative efficacy in human RBC, with post-thaw recovery rates on par with those seen following unprotected freezing. Even at the highest performing concentration (10.0% w/v), human RBC recovery remained low (16.08% ± 2.96%), highlighting the ineffectiveness of tricine in preserving human RBC integrity. Further analyses revealed greater hydrophilicity in sheep haemoglobin, which potentially influences freezing tolerance.</p><p><strong>Conclusion: </strong>Despite promising results within the ovine model, tricine lacks CPA efficacy for human RBC. Species differences in RBC physiology likely contribute to these discrepancies. These findings emphasize the need for rigorous model selection in cryopreservation research and further investigation into CPA mechanisms.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1113-1122"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12602133/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144761518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-08-06DOI: 10.1111/vox.70087
Tatiana Stephenson, Anita Howell, Carly Olafson, Chryslain Sumian, Stefan Reichenberg, Quentin Brebant, Ken McTaggart, Geraldine M Walsh
Background and objectives: Due to toxicity concerns, di(2-ethylhexyl) phthalate (DEHP)-the most used plasticizer in polyvinyl chloride (PVC) whole blood (WB) collection and processing bag sets-will be effectively prohibited in medical devices in Europe from 2030. Removal of DEHP will primarily impact the in vitro quality of red blood cell (RBC) concentrates (RCCs) and DEHP-free sets with alternate additive solutions (ASs) that better preserve RBCs in the absence of DEHP are being developed. This study compared the in vitro quality of RCCs from di (2-ethylhexyl) terephthalate (DEHT)/phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) and DEHP/saline-adenine-glucose-mannitol (SAGM) sets.
Materials and methods: WB was collected into citrate-phosphate-dextrose (CPD) in either 500-mL DEHP/SAGM (n = 37) or prototype 475-mL DEHT/PAGGSM bag sets (n = 29). Leucoreduced (LR)-RCCs were produced using semi-automated top/bottom processing within 24 h of collection. RBC quality, including haemolysis, supernatant metabolic parameters and RBC deformability, was measured on D43 (1-day after expiry).
Results: All RCCs in the study had haemolysis <0.8%, and there was no statistically significant difference between haemolysis in DEHT/PAGGSM and DEHP/SAGM RCC (p = 0.083). Tolerance bound analysis indicated that RCCs in DEHT/PAGGSM produced using Canadian Blood Services' main production method would meet current Canadian Standards Association (CSA) CAN/CSA-Z902:25 quality control (QC) requirements for RCCs. There were some differences in metabolic in vitro quality measures, and RBCs in DEHT/PAGGSM were slightly less deformable (lower maximum elongation index [EIMAX]) and required larger amounts of force (KEI) to physically deform.
Conclusion: RBCs have acceptable in vitro quality at expiry in DEHT/PAGGSM, supporting a 42-day shelf life.
背景和目的:由于毒性问题,二(2-乙基己基)邻苯二甲酸二酯(DEHP)——聚氯乙烯(PVC)全血(WB)收集和处理袋组中最常用的增塑剂——将从2030年起在欧洲的医疗器械中被有效禁止。去除DEHP将主要影响红细胞(RBC)浓缩液(RCCs)的体外质量,目前正在开发替代添加剂溶液(ASs),在没有DEHP的情况下更好地保存红细胞。本研究比较了二(2-乙基己基)对苯二甲酸二酯(DEHT)/磷酸腺苷-葡萄糖-鸟苷-盐-甘露醇(PAGGSM)和DEHP/盐-腺嘌呤-葡萄糖-甘露醇(SAGM)两组rcc的体外质量。材料和方法:WB在500 ml DEHP/SAGM (n = 37)或475 ml DEHT/PAGGSM原型袋组(n = 29)中收集到柠檬酸盐-磷酸盐-葡萄糖(CPD)中。低还原(LR)- rcc在收集后24小时内采用半自动上下处理生产。在第43天(过期后1天)测量红细胞质量,包括溶血、上清代谢参数和红细胞变形能力。结果:研究中所有的rcc都有溶血(MAX),并且需要更大的力(KEI)来物理变形。结论:红细胞在DEHT/PAGGSM中具有可接受的体外质量,支持42天的保质期。
{"title":"In vitro quality of whole blood-derived red cell concentrates collected, processed and stored in a blood bag set plasticized with di (2-ethylhexyl) terephthalate.","authors":"Tatiana Stephenson, Anita Howell, Carly Olafson, Chryslain Sumian, Stefan Reichenberg, Quentin Brebant, Ken McTaggart, Geraldine M Walsh","doi":"10.1111/vox.70087","DOIUrl":"10.1111/vox.70087","url":null,"abstract":"<p><strong>Background and objectives: </strong>Due to toxicity concerns, di(2-ethylhexyl) phthalate (DEHP)-the most used plasticizer in polyvinyl chloride (PVC) whole blood (WB) collection and processing bag sets-will be effectively prohibited in medical devices in Europe from 2030. Removal of DEHP will primarily impact the in vitro quality of red blood cell (RBC) concentrates (RCCs) and DEHP-free sets with alternate additive solutions (ASs) that better preserve RBCs in the absence of DEHP are being developed. This study compared the in vitro quality of RCCs from di (2-ethylhexyl) terephthalate (DEHT)/phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) and DEHP/saline-adenine-glucose-mannitol (SAGM) sets.</p><p><strong>Materials and methods: </strong>WB was collected into citrate-phosphate-dextrose (CPD) in either 500-mL DEHP/SAGM (n = 37) or prototype 475-mL DEHT/PAGGSM bag sets (n = 29). Leucoreduced (LR)-RCCs were produced using semi-automated top/bottom processing within 24 h of collection. RBC quality, including haemolysis, supernatant metabolic parameters and RBC deformability, was measured on D43 (1-day after expiry).</p><p><strong>Results: </strong>All RCCs in the study had haemolysis <0.8%, and there was no statistically significant difference between haemolysis in DEHT/PAGGSM and DEHP/SAGM RCC (p = 0.083). Tolerance bound analysis indicated that RCCs in DEHT/PAGGSM produced using Canadian Blood Services' main production method would meet current Canadian Standards Association (CSA) CAN/CSA-Z902:25 quality control (QC) requirements for RCCs. There were some differences in metabolic in vitro quality measures, and RBCs in DEHT/PAGGSM were slightly less deformable (lower maximum elongation index [EI<sub>MAX</sub>]) and required larger amounts of force (K<sub>EI</sub>) to physically deform.</p><p><strong>Conclusion: </strong>RBCs have acceptable in vitro quality at expiry in DEHT/PAGGSM, supporting a 42-day shelf life.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1103-1112"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12602130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144795663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-01-27DOI: 10.1111/vox.13798
Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman
Background and objectives: Access to blood components in pre-hospital bleeding resuscitation is challenging. Dried plasma is a logistically superior alternative, and new products are emerging. Therefore, we aimed to evaluate laboratory and practical differences in three differently produced dried plasma products.
Materials and methods: Single-donor lyophilized LyoPlas®, pooled-donor, lyophilized and pathogen-reduced OctaplasLG Powder®, and single-donor sprayed-dried FrontlineODP™ along with fresh plasma (in-house, pre-FrontlineODP and OctaplasLG) as controls were analysed (n = 8). Laboratory tests included measurements of various coagulation factors and thromboelastography. The practical evaluation of the dried plasma products included preparation time, time to dissolve the dried plasma and total time, together with subjective opinions from eight clinical users.
Results: The coagulation factor content was within human reference ranges for all dried plasma, with approximately 10%-20% loss compared with fresh plasma. More variations were observed in the single-donor products compared with the pooled products. Clot formation analysed by thromboelastography showed normal graphs. Reconstitution time was similar, ranging from on average 7-9 min. In the user evaluation, the reconstitution time and the possibility of using a plastic bag for the transfusion were emphasized as important, the latter fulfilled by two of the products.
Conclusion: The study supports that dried plasma may be produced with lyophilization or spray-drying technique, as well as with the addition of pathogen reduction, with preserved coagulation capability. The products were reconstituted in acceptable time and deemed feasible for pre-hospital use by eighth test users.
{"title":"An experimental comparison and user evaluation of three different dried plasma products.","authors":"Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman","doi":"10.1111/vox.13798","DOIUrl":"10.1111/vox.13798","url":null,"abstract":"<p><strong>Background and objectives: </strong>Access to blood components in pre-hospital bleeding resuscitation is challenging. Dried plasma is a logistically superior alternative, and new products are emerging. Therefore, we aimed to evaluate laboratory and practical differences in three differently produced dried plasma products.</p><p><strong>Materials and methods: </strong>Single-donor lyophilized LyoPlas®, pooled-donor, lyophilized and pathogen-reduced OctaplasLG Powder®, and single-donor sprayed-dried FrontlineODP™ along with fresh plasma (in-house, pre-FrontlineODP and OctaplasLG) as controls were analysed (n = 8). Laboratory tests included measurements of various coagulation factors and thromboelastography. The practical evaluation of the dried plasma products included preparation time, time to dissolve the dried plasma and total time, together with subjective opinions from eight clinical users.</p><p><strong>Results: </strong>The coagulation factor content was within human reference ranges for all dried plasma, with approximately 10%-20% loss compared with fresh plasma. More variations were observed in the single-donor products compared with the pooled products. Clot formation analysed by thromboelastography showed normal graphs. Reconstitution time was similar, ranging from on average 7-9 min. In the user evaluation, the reconstitution time and the possibility of using a plastic bag for the transfusion were emphasized as important, the latter fulfilled by two of the products.</p><p><strong>Conclusion: </strong>The study supports that dried plasma may be produced with lyophilization or spray-drying technique, as well as with the addition of pathogen reduction, with preserved coagulation capability. The products were reconstituted in acceptable time and deemed feasible for pre-hospital use by eighth test users.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1058-1065"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12602137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-08-11DOI: 10.1111/vox.70090
Michael Cahillane, Nicola Pearce, Christine Saunders, Nicole Polidano, Stephanie O'Brien, Laura Paletto, Thomas Scorer, Chloe George
Background and objectives: The Welsh Blood Service (WBS) produces pooled platelet concentrates from four buffy coats (4BC-PC), achieving consistently high platelet yields exceeding the UK specification. Three buffy coat platelet concentrates (3BC-PC) offer the potential for improved supply chain resilience and increased production capacity. Data modelling was performed to evaluate the local feasibility of 3BC-PC production.
Materials and methods: Platelet recovery (%) was calculated from 41 4BC-PC to generate three reference values (maximum, average and minimum). Measurements from the 164 BCs were used to model 3BC-PC production, with further analysis determining the impacts of manufacturing variability. Calculated yields were assessed against UK, European (EU) and UK contingency specifications. Potential production increases for WBS were estimated alongside statistical significance and effect size of the modelling.
Results: Data modelling with 3BC-PC showed 100% compliance against UK minimum requirements approved as a contingency measure (≥75% achieving ≥150 × 109/unit), while compliance to EU specification (≥90% achieving ≥200 × 109/unit) ranged from 93.2% to 100%. Compliance to routine UK specification (≥75% achieving ≥240 × 109/unit) varied for the three modelled scenarios (54.5%-86.8%). Modelling indicated potential increases in platelet concentrate (PC) production, with notable rises for Groups A and O components of approximately 30%-40%.
Conclusion: Data modelling supports 3BC-PC as a feasible alternative to 4BC-PC, offering increased production capacity. Modelled 3BC-PC met UK contingency and EU specifications. Compliance with the UK standard specification was variable and suggests the need for further optimization. Real-world validation would confirm whether this is a practical proposition.
{"title":"Three buffy coat platelet concentrates: Use of data modelling to make more with less.","authors":"Michael Cahillane, Nicola Pearce, Christine Saunders, Nicole Polidano, Stephanie O'Brien, Laura Paletto, Thomas Scorer, Chloe George","doi":"10.1111/vox.70090","DOIUrl":"10.1111/vox.70090","url":null,"abstract":"<p><strong>Background and objectives: </strong>The Welsh Blood Service (WBS) produces pooled platelet concentrates from four buffy coats (4BC-PC), achieving consistently high platelet yields exceeding the UK specification. Three buffy coat platelet concentrates (3BC-PC) offer the potential for improved supply chain resilience and increased production capacity. Data modelling was performed to evaluate the local feasibility of 3BC-PC production.</p><p><strong>Materials and methods: </strong>Platelet recovery (%) was calculated from 41 4BC-PC to generate three reference values (maximum, average and minimum). Measurements from the 164 BCs were used to model 3BC-PC production, with further analysis determining the impacts of manufacturing variability. Calculated yields were assessed against UK, European (EU) and UK contingency specifications. Potential production increases for WBS were estimated alongside statistical significance and effect size of the modelling.</p><p><strong>Results: </strong>Data modelling with 3BC-PC showed 100% compliance against UK minimum requirements approved as a contingency measure (≥75% achieving ≥150 × 10<sup>9</sup>/unit), while compliance to EU specification (≥90% achieving ≥200 × 10<sup>9</sup>/unit) ranged from 93.2% to 100%. Compliance to routine UK specification (≥75% achieving ≥240 × 10<sup>9</sup>/unit) varied for the three modelled scenarios (54.5%-86.8%). Modelling indicated potential increases in platelet concentrate (PC) production, with notable rises for Groups A and O components of approximately 30%-40%.</p><p><strong>Conclusion: </strong>Data modelling supports 3BC-PC as a feasible alternative to 4BC-PC, offering increased production capacity. Modelled 3BC-PC met UK contingency and EU specifications. Compliance with the UK standard specification was variable and suggests the need for further optimization. Real-world validation would confirm whether this is a practical proposition.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1123-1131"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12602124/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144822740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-03-24DOI: 10.1111/vox.70019
Christie Vermeulen, Nan van Geloven, Bart Mertens, Saskia E Spelmink, Martin R Schipperus, Mart P Janssen, Jean-Louis H Kerkhoffs, Gijs den Besten, Annegeet G van den Bos, Irene M L W Körver-Keularts, Daan van de Kerkhof, Harriët J H Klinkspoor, Karen M K De Vooght, Adriaan J van Gammeren, Henk Russcher, Josephine W M Heijnen, Dirk de Korte, Pieter F van der Meer, Thomas R L Klei
Background and objectives: The use of di-ethyl-hexyl-phthalate (DEHP) in medical devices will be banned in the European Union from 1 July 2030, onwards. It is therefore important to evaluate the performance of non-DEHP blood collection system alternatives. Previously, we reported that red cell concentrates (RCCs) in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) stored in non-DEHP blood containers did not result in an increased transfusion reaction rate (TRR) as compared with saline-adenine-glucose-mannitol (SAGM)/DEHP-stored RCC. The current study aimed to extend the dataset and confirm previous findings.
Materials and methods: A quasi-randomized observational study was conducted to compare the number and type of transfusion reactions. A 95% credibility interval for the TRR odds ratio (OR) was calculated.
Results: A total of 7507 BTHC/PAGGSM and 25,371 DEHP/SAGM RCCs were transfused, yielding a TRR of 0.35% (0.22%-0.49%) and 0.20% (0.15%-0.26%), respectively, with an OR of 1.76 (1.10-2.81). Pooling data of the current and previous study resulted in an OR of 1.36 (0.90-2.08). Restricting the pooled data to imputability categories 'possible', 'probable' and 'definite' yielded an OR of 1.09 (0.66-1.81).
Conclusion: An increased TRR was observed for BTHC/PAGGSM in the new dataset, though it was still consistent with those of DEHP when aggregating data from both studies.
{"title":"Clinical evaluation of red cell concentrates in non-DEHP plasticized containers compared with standard DEHP plasticized containers: A quasi-randomized observational multicentre study.","authors":"Christie Vermeulen, Nan van Geloven, Bart Mertens, Saskia E Spelmink, Martin R Schipperus, Mart P Janssen, Jean-Louis H Kerkhoffs, Gijs den Besten, Annegeet G van den Bos, Irene M L W Körver-Keularts, Daan van de Kerkhof, Harriët J H Klinkspoor, Karen M K De Vooght, Adriaan J van Gammeren, Henk Russcher, Josephine W M Heijnen, Dirk de Korte, Pieter F van der Meer, Thomas R L Klei","doi":"10.1111/vox.70019","DOIUrl":"10.1111/vox.70019","url":null,"abstract":"<p><strong>Background and objectives: </strong>The use of di-ethyl-hexyl-phthalate (DEHP) in medical devices will be banned in the European Union from 1 July 2030, onwards. It is therefore important to evaluate the performance of non-DEHP blood collection system alternatives. Previously, we reported that red cell concentrates (RCCs) in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) stored in non-DEHP blood containers did not result in an increased transfusion reaction rate (TRR) as compared with saline-adenine-glucose-mannitol (SAGM)/DEHP-stored RCC. The current study aimed to extend the dataset and confirm previous findings.</p><p><strong>Materials and methods: </strong>A quasi-randomized observational study was conducted to compare the number and type of transfusion reactions. A 95% credibility interval for the TRR odds ratio (OR) was calculated.</p><p><strong>Results: </strong>A total of 7507 BTHC/PAGGSM and 25,371 DEHP/SAGM RCCs were transfused, yielding a TRR of 0.35% (0.22%-0.49%) and 0.20% (0.15%-0.26%), respectively, with an OR of 1.76 (1.10-2.81). Pooling data of the current and previous study resulted in an OR of 1.36 (0.90-2.08). Restricting the pooled data to imputability categories 'possible', 'probable' and 'definite' yielded an OR of 1.09 (0.66-1.81).</p><p><strong>Conclusion: </strong>An increased TRR was observed for BTHC/PAGGSM in the new dataset, though it was still consistent with those of DEHP when aggregating data from both studies.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1183-1188"},"PeriodicalIF":1.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}