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Assessing red blood cell product quality with 2,3-DPG, ATP and p50 assays: A BEST Collaborative study. 用2,3- dpg、ATP和p50检测评估红细胞产品质量:一项BEST合作研究。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-23 DOI: 10.1111/vox.70117
Tamar P Feldman, Mackenzie Brandon-Coatham, Jayme Kurach, Carly Olafson, Jason Acker, Michael Wellington, Bethany L Brown

To comply with regulatory guidelines, blood products undergo laboratory testing to assess red blood cell (RBC) quality during manufacturing, storage and delivery. Measurements of metabolites such as 2,3-diphosphoglycerate (2,3-DPG) have been relied upon as proxies for in vivo function, although their predictive value for clinical efficacy is not well substantiated. Following the discontinuation of the only validated commercial assay for 2,3-DPG, we reviewed existing literature and performed a retrospective analysis of datasets from two blood centres in North America to evaluate adenosine-5'-triphosphate (ATP) and p50 as alternatives. The literature did not provide sufficient evidence to support adopting p50 in place of 2,3-DPG. Although the assays are complementary, we found several exceptions in which biological and technical factors reduced the strength of correlation between 2,3-DPG and p50. ATP, another marker of RBC quality, was not well correlated either with 2,3-DPG or p50 in quality monitoring datasets or with in vivo circulation kinetics in healthy adults. Our assessment underscores the need for a replacement assay for 2,3-DPG for comprehensive characterization of novel red cell products and storage conditions.

为了遵守监管指引,血液制品在生产、储存和运送过程中都要经过实验室检测,以评估红细胞(RBC)的质量。代谢物如2,3-二磷酸甘油酸(2,3- dpg)的测量被认为是体内功能的替代指标,尽管它们对临床疗效的预测价值尚未得到很好的证实。在唯一经过验证的2,3- dpg商业检测停止后,我们回顾了现有文献,并对北美两个血液中心的数据集进行了回顾性分析,以评估腺苷-5'-三磷酸(ATP)和p50作为替代品。文献没有提供足够的证据支持采用p50代替2,3- dpg。虽然测定是互补的,但我们发现了一些例外,其中生物和技术因素降低了2,3- dpg和p50之间的相关性强度。ATP是红细胞质量的另一个标志,在质量监测数据集中与2,3- dpg或p50或健康成人体内循环动力学都没有很好的相关性。我们的评估强调需要一种替代2,3- dpg的检测方法来全面表征新的红细胞产物和储存条件。
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引用次数: 0
Comments on Thomas et al. 'Management strategies and clinical outcomes of obstetric patients who decline allogeneic blood transfusion'. 对Thomas等人的评论。“产科患者拒绝异体输血的管理策略和临床结果”。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-31 DOI: 10.1111/vox.70110
Rui Terada, Yuko Mishima
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引用次数: 0
Perceptions of deferred blood donors regarding false-positive screening results for infectious diseases and European blood establishment strategies. 推迟献血者对传染病假阳性筛查结果和欧洲血液机构战略的看法。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-14 DOI: 10.1111/vox.70115
Jenny Erica Beckman, Niubel Díaz Padilla, Afke van der Woud, Peter van den Burg, Vĕra Novotny

Background and objectives: This study explores the perceptions of deferred blood donors in the Netherlands regarding the information provided upon receiving false-positive screening (FPS) deferral letters for infectious diseases. To ensure blood supply safety, rigorous screening for infectious agents is implemented by blood establishments. However, FPS results can create challenges after donor notification, leading to psychological distress.

Materials and methods: The study purposively selected whole-blood donors who had received deferral letters due to two FPS results between April and October 2023. Semi-structured interviews, guided by the Health Belief Model (HBM), examined health behaviours through seven constructs. Additionally, a survey of European Blood Alliance (EBA) members was conducted to gather insights on FPS management practices. Interview transcripts were coded and modelled to illustrate relationships between the themes.

Results: Ten in-depth interviews were held, revealing varied responses: some donors felt reassured by safety protocols, while the majority experienced psychological distress. Key themes included emotional reactions, contact methods, follow-up communication, engagement with Sanquin Blood Supply and altruistic motivations. The EBA survey shows varied FPS notification practices, rejection protocols, limited donor reaction studies and diverse support measures.

Conclusion: Improving communication clarity, providing follow-up procedures and adopting best practices from EBA members can enhance donor experience. These efforts are essential for refining the deferral process and improving donor perceptions, ultimately benefiting the donor and the blood supply system.

背景和目的:本研究探讨了荷兰延迟献血者在收到假阳性筛查(FPS)传染病延迟信件时所提供的信息的看法。为确保血液供应安全,血液机构对传染性病原体进行了严格的筛查。然而,FPS结果可能在供体通知后产生挑战,导致心理困扰。材料和方法:本研究有目的地选择了在2023年4月至10月期间因两次FPS结果而收到延迟信件的全血献血者。在健康信念模型(HBM)的指导下,半结构化访谈通过七个结构来检查健康行为。此外,我们还对欧洲血液联盟(EBA)成员进行了调查,以收集FPS管理实践的见解。采访记录被编码和建模,以说明主题之间的关系。结果:进行了十次深度访谈,揭示了不同的反应:一些捐赠者对安全协议感到放心,而大多数人则感到心理困扰。关键主题包括情绪反应、联系方法、后续沟通、与Sanquin血液供应公司的接触和利他动机。EBA调查显示了不同的FPS通知实践、排斥协议、有限的供体反应研究和不同的支持措施。结论:提高沟通清晰度,提供后续程序和采用EBA成员的最佳实践可以提高捐赠体验。这些努力对于完善延迟过程和改善献血者的看法至关重要,最终使献血者和血液供应系统受益。
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引用次数: 0
A target trial emulation to estimate the effect of blood donation on mortality among blood donors in Australia. 目标试验模拟估计献血对澳大利亚献血者死亡率的影响。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-14 DOI: 10.1111/vox.70118
Md Morshadur Rahman, Surendra Karki, Andrew Hayen

Background and objectives: The healthy donor effect (HDE) is a bias evident when comparing the effect of blood donation on health, often leading to conclusions such as 'donors with a high frequency of donation have better health outcomes than non-donors or donors with a lower frequency of donation'. To overcome this bias, we used a target trial emulation method while examining the relationship between blood donation and mortality among blood donors in Australia.

Materials and methods: We emulated 60 target trials from July 2006 to June 2011 using the Sax Institute's 45 and Up Study data, which was linked with other electronic health databases, including blood donation data in New South Wales, Australia. We conducted observational analogues of intention-to-treat (ITT) analyses comparing donors with non-donors, adjusting for variables that impact mortality. Hazard ratios (HRs) were approximated by the pooled logistic regression model.

Results: The 60 trials generated 263,300 person-trials with 121,967 unique participants included in the analysis. The unadjusted ITT mortality HR (95% confidence interval [CI]) between donors and non-donors was 0.57 (95% CI: 0.42-0.77). The HR was 0.70 (95% CI: 0.52-0.95) and 1.0 (95% CI: 0.73-1.35) after adjusting for age and sex, and then all the baseline covariates, respectively.

Conclusion: Blood donation did not significantly affect mortality during the follow-up when appropriate methods to mitigate the HDE were used, although blood donors were observed to have a lower crude mortality rate than non-donors.

背景和目的:在比较献血对健康的影响时,健康献血者效应(HDE)是一个明显的偏差,通常会得出诸如“献血频率高的献血者比不献血者或献血频率较低的献血者有更好的健康结果”之类的结论。为了克服这种偏差,我们在检查澳大利亚献血者献血与死亡率之间的关系时使用了目标试验模拟方法。材料和方法:从2006年7月到2011年6月,我们使用Sax研究所的45和Up研究数据模拟了60个目标试验,该数据与其他电子健康数据库相关联,包括澳大利亚新南威尔士州的献血数据。我们进行了意向治疗(ITT)的观察性类比分析,比较了供体和非供体,调整了影响死亡率的变量。风险比(hr)采用混合逻辑回归模型近似。结果:60项试验共纳入263,300人,分析中包含121,967名独特参与者。供者与非供者之间未调整的ITT死亡率HR(95%可信区间[CI])为0.57 (95% CI: 0.42-0.77)。在调整年龄和性别以及所有基线协变量后,HR分别为0.70 (95% CI: 0.52-0.95)和1.0 (95% CI: 0.73-1.35)。结论:在使用适当的方法来减轻HDE时,献血对随访期间的死亡率没有显著影响,尽管观察到献血者的粗死亡率低于非献血者。
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引用次数: 0
Enhanced O2 availability in platelet concentrates stored for neonatal transfusion is independent of agitation: Evidence from direct oximetry and Fickian diffusion modelling. 储存用于新生儿输血的血小板浓缩物中氧可用性的增强与躁动无关:来自直接血氧测定和菲克扩散模型的证据。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-28 DOI: 10.1111/vox.70101
Dean Pym, Oleg Grinberg, Amanda J Davies, Jessica O Williams, Christine Saunders, Chloë E George, Philip E James

Background and objectives: Platelet transfusions are essential for mitigating the bleeding risk of neonatal patients with thrombocytopenia. As neonatal patients have a small blood volume, adult therapeutic dose platelet units are split into reduced-volume storage containers to maximize the use of the donated product and reduce donor exposure. The shelf-life of platelets stored in reduced-volume containers, however, is limited to 5 days. Agitation in platelet concentrate (PC) storage is thought to promote gaseous exchange by maintaining a gradient of O2 across the bag film; however, recent studies have shown that agitation-induced shear promotes the progressive decline of platelet quality over storage.

Materials and methods: Electron paramagnetic resonance oximetry and Fickian diffusion modelling of O2 were used to investigate the differences in O2 availability, by assessing the O2 concentration, oxygen consumption rate (OCR), influx of O2, total PC OCR and O2 distribution in PCs stored under routine conditions in neonatal (Macopharma, VQE605B) versus adult (Haemonetics, ATSBC1ESE) PC storage containers. The influence of agitation on neonatal PC storage was evaluated.

Results: Results indicate neonatal PCs experience significantly higher O2 availability compared to adult PCs and can withstand greater insult to their ambient O2 concentration. Adjusting the agitation frequency of neonatal PCs stored from 20 to 400 rpm had no detrimental effect on O2 availability, compared to storage at 60 rpm.

Conclusion: Neonatal PCs can maintain higher O2 availability and tolerate reduced agitation without compromising oxygenation; therefore, reduced agitation strategies may be a feasible option to minimize shear during storage without compromising O2 availability.

背景和目的:血小板输注对于减轻新生儿血小板减少症患者出血风险至关重要。由于新生儿患者血容量小,成人治疗剂量血小板单位被分成小容量储存容器,以最大限度地利用捐献产品并减少献血者暴露。然而,储存在小容量容器中的血小板的保质期限制为5天。在血小板浓缩物(PC)储存中,搅拌被认为通过维持O2在袋膜上的梯度来促进气体交换;然而,最近的研究表明,搅拌引起的剪切促进血小板质量在储存过程中的逐渐下降。材料和方法:采用电子顺磁共振血氧仪和氧的菲克扩散模型,通过评估常规条件下储存在新生儿(Macopharma, VQE605B)和成人(Haemonetics, ATSBC1ESE) PC中的氧气浓度、耗氧量(OCR)、氧气流入、总PC OCR和氧气分布,研究氧气可用性的差异。评估躁动对新生儿PC储存的影响。结果:结果表明,新生儿pc的氧气可用性明显高于成人pc,并且可以承受更大的环境氧气浓度的损害。与储存在60 rpm的新生儿pc相比,将搅拌频率从20 rpm调整到400 rpm对氧气可用性没有不利影响。结论:新生儿PCs可维持较高的氧可用性,在不影响氧合的情况下耐受躁动减少;因此,减少搅拌策略可能是一种可行的选择,可以在不影响氧气可用性的情况下最大限度地减少储存期间的剪切。
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引用次数: 0
Nursing staff satisfaction with the use of several transfusion safety systems at a university hospital. 某大学医院护理人员对几种输血安全系统使用的满意度。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-24 DOI: 10.1111/vox.70119
C Otín-Aparicio, N Alegre-Santos, C Cuellas-Roca, N Huguet-Otero, N Llurba-Cunillera, M Rubí-Cabrera

Background and objectives: At the Hospital Universitari Arnau de Vilanova Lleida, Spain, nursing staff utilize different transfusion safety systems (TSSs) depending on their clinical unit. These range from a basic model involving wristband-based patient identification to a more advanced system incorporating a Personal Digital Assistant (PDA), location beacon, physical barriers, specific wristbands and personal identification. This study aimed to compare nursing staff satisfaction across the various TSSs used.

Materials and methods: In March 2025, nursing staff were invited to voluntarily and anonymously complete an online, self-designed questionnaire assessing their perceptions of the systems in use.

Results: A total of 120 nurses participated, representing 15.6% of the total population. While overall satisfaction did not differ significantly by system type, 40.6% of respondents reported a negative perception. Users of the basic system felt less safe (65.4%) and considered it less effective at preventing errors (64.1%) than those using the complex system (87.2% and 92.8%, respectively). However, the complex system was associated with more frequent technical or usability issues (66.7%) compared with the basic system (34.6%), which contributed notably to dissatisfaction.

Conclusion: Although specific factors influencing satisfaction were identified, no clear preference emerged regarding overall system satisfaction. The variability in responses may reflect the subjective nature of satisfaction. An optimal TSS would combine adaptability to staff needs, perceived safety, ease of use, intuitive visual cues, time efficiency and high reliability with minimal technical complications.

背景和目的:在西班牙阿瑙大学医院,护理人员根据其临床单位使用不同的输血安全系统(tss)。从基于腕带的病人识别的基本模型到更高级的系统,包括个人数字助理(PDA)、定位信标、物理屏障、特定腕带和个人识别。本研究的目的是比较护理人员的满意度在不同的tss使用。材料和方法:2025年3月,护理人员被邀请自愿匿名完成一份自行设计的在线问卷,评估他们对正在使用的系统的看法。结果:共有120名护士参与调查,占总人数的15.6%。虽然系统类型的总体满意度没有显着差异,但40.6%的受访者报告了负面看法。与使用复杂系统的用户(分别为87.2%和92.8%)相比,使用基本系统的用户(65.4%)认为更不安全,认为在防止错误方面效果更差(64.1%)。然而,与基本系统(34.6%)相比,复杂系统与更频繁的技术或可用性问题(66.7%)相关,这是引起不满的主要原因。结论:虽然确定了影响满意度的具体因素,但对整体系统满意度没有明确的偏好。反应的可变性可能反映了满意度的主观性。最佳的TSS应结合对工作人员需要的适应性、可感知的安全性、易于使用、直观的视觉提示、时间效率和高可靠性以及最小的技术复杂性。
{"title":"Nursing staff satisfaction with the use of several transfusion safety systems at a university hospital.","authors":"C Otín-Aparicio, N Alegre-Santos, C Cuellas-Roca, N Huguet-Otero, N Llurba-Cunillera, M Rubí-Cabrera","doi":"10.1111/vox.70119","DOIUrl":"10.1111/vox.70119","url":null,"abstract":"<p><strong>Background and objectives: </strong>At the Hospital Universitari Arnau de Vilanova Lleida, Spain, nursing staff utilize different transfusion safety systems (TSSs) depending on their clinical unit. These range from a basic model involving wristband-based patient identification to a more advanced system incorporating a Personal Digital Assistant (PDA), location beacon, physical barriers, specific wristbands and personal identification. This study aimed to compare nursing staff satisfaction across the various TSSs used.</p><p><strong>Materials and methods: </strong>In March 2025, nursing staff were invited to voluntarily and anonymously complete an online, self-designed questionnaire assessing their perceptions of the systems in use.</p><p><strong>Results: </strong>A total of 120 nurses participated, representing 15.6% of the total population. While overall satisfaction did not differ significantly by system type, 40.6% of respondents reported a negative perception. Users of the basic system felt less safe (65.4%) and considered it less effective at preventing errors (64.1%) than those using the complex system (87.2% and 92.8%, respectively). However, the complex system was associated with more frequent technical or usability issues (66.7%) compared with the basic system (34.6%), which contributed notably to dissatisfaction.</p><p><strong>Conclusion: </strong>Although specific factors influencing satisfaction were identified, no clear preference emerged regarding overall system satisfaction. The variability in responses may reflect the subjective nature of satisfaction. An optimal TSS would combine adaptability to staff needs, perceived safety, ease of use, intuitive visual cues, time efficiency and high reliability with minimal technical complications.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1242-1248"},"PeriodicalIF":1.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138809","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}
引用次数: 0
Reply to commentary on 'Restless legs syndrome among blood donors: A systematic review and meta-analysis'. 回复对“献血者的不宁腿综合征:系统回顾和荟萃分析”的评论。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-22 DOI: 10.1111/vox.70109
Alain M Ngoma, Paulin B Mutombo, Mahmoud Mosli, Magot D Omokoko, Kenneth E Nollet, Hitoshi Ohto
{"title":"Reply to commentary on 'Restless legs syndrome among blood donors: A systematic review and meta-analysis'.","authors":"Alain M Ngoma, Paulin B Mutombo, Mahmoud Mosli, Magot D Omokoko, Kenneth E Nollet, Hitoshi Ohto","doi":"10.1111/vox.70109","DOIUrl":"10.1111/vox.70109","url":null,"abstract":"","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1287-1288"},"PeriodicalIF":1.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145126116","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}
引用次数: 0
Evaluation of 6 years of fetal RHD screening in Ireland: From implementation to practice. 爱尔兰6年胎儿RHD筛查的评价:从实施到实践。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-10 DOI: 10.1111/vox.70107
Helen Ryan, Mark Lambert, Sorcha Ní Loingsigh, Richard Hagan, Diarmaid O'Donghaile

Background and objectives: The discovery of circulating fetal DNA in maternal plasma enabled non-invasive prenatal testing (NIPT) for targeted anti-D prophylaxis. In 2019, Ireland implemented an in-house test to guide this care. Here, we report 6 years of service.

Materials and methods: Cell-free fetal DNA (cffDNA) was extracted from 1000-μL plasma from pregnant RhD negative women at gestation age (GA) > 11 weeks. Samples were tested in triplicate for RHD by quantitative PCR using a multiplex assay of RHD exons 7 and 10.

Results: Of the 20,099 samples tested, 58.2% were predicted RhD positive and 36.9% were predicted RhD negative. Discrepancies were seen in 52 cases: 7 (0.03%) were predicted RhD negative but cord RhD positive and 45 (0.2%) were predicted RhD positive but cord RhD negative.

Conclusion: This test has ensured that over 7400 women have avoided unnecessary anti-D prophylaxis. There were few discrepant results, with false negatives posing a greater clinical risk due to withheld anti-D, increasing immunization risk. Three were linked to pre-analytical errors prompting procedural changes. Due to the success of fetal RHD screening, cord blood testing has been discontinued in some countries; a practice which could be reviewed in Ireland.

背景和目的:母体血浆中循环胎儿DNA的发现使无创产前检测(NIPT)能够用于靶向抗- d预防。2019年,爱尔兰实施了一项内部测试来指导这种护理。在这里,我们报告了6年的服务。材料与方法:从孕龄(GA) bb0 ~ 11周RhD阴性孕妇1000 μ l血浆中提取无细胞胎儿DNA (cffDNA)。使用RHD外显子7和10的多重分析,对三份样品进行RHD定量PCR检测。结果:在20,099份样本中,预测RhD阳性的占58.2%,预测RhD阴性的占36.9%。52例出现差异:7例(0.03%)预测RhD阴性但脐带RhD阳性,45例(0.2%)预测RhD阳性但脐带RhD阴性。结论:该检测确保7400多名妇女避免了不必要的抗- d预防。结果差异不大,假阴性由于抗- d被隐瞒,临床风险更大,增加了免疫风险。其中三起与分析前错误有关,导致程序发生变化。由于胎儿RHD筛查的成功,脐带血检测已在一些国家停止;这种做法可以在爱尔兰进行审查。
{"title":"Evaluation of 6 years of fetal RHD screening in Ireland: From implementation to practice.","authors":"Helen Ryan, Mark Lambert, Sorcha Ní Loingsigh, Richard Hagan, Diarmaid O'Donghaile","doi":"10.1111/vox.70107","DOIUrl":"10.1111/vox.70107","url":null,"abstract":"<p><strong>Background and objectives: </strong>The discovery of circulating fetal DNA in maternal plasma enabled non-invasive prenatal testing (NIPT) for targeted anti-D prophylaxis. In 2019, Ireland implemented an in-house test to guide this care. Here, we report 6 years of service.</p><p><strong>Materials and methods: </strong>Cell-free fetal DNA (cffDNA) was extracted from 1000-μL plasma from pregnant RhD negative women at gestation age (GA) > 11 weeks. Samples were tested in triplicate for RHD by quantitative PCR using a multiplex assay of RHD exons 7 and 10.</p><p><strong>Results: </strong>Of the 20,099 samples tested, 58.2% were predicted RhD positive and 36.9% were predicted RhD negative. Discrepancies were seen in 52 cases: 7 (0.03%) were predicted RhD negative but cord RhD positive and 45 (0.2%) were predicted RhD positive but cord RhD negative.</p><p><strong>Conclusion: </strong>This test has ensured that over 7400 women have avoided unnecessary anti-D prophylaxis. There were few discrepant results, with false negatives posing a greater clinical risk due to withheld anti-D, increasing immunization risk. Three were linked to pre-analytical errors prompting procedural changes. Due to the success of fetal RHD screening, cord blood testing has been discontinued in some countries; a practice which could be reviewed in Ireland.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1259-1262"},"PeriodicalIF":1.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034282","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}
引用次数: 0
Challenges in promoting stewardship of albumin: A comparative perspective from recent guidelines. 促进白蛋白管理的挑战:来自最近指南的比较视角。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-24 DOI: 10.1111/vox.70121
Tomohiko Sato, Akito Nozaki, Satoshi Yasumura, Masanori Matsumoto
{"title":"Challenges in promoting stewardship of albumin: A comparative perspective from recent guidelines.","authors":"Tomohiko Sato, Akito Nozaki, Satoshi Yasumura, Masanori Matsumoto","doi":"10.1111/vox.70121","DOIUrl":"10.1111/vox.70121","url":null,"abstract":"","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1289-1291"},"PeriodicalIF":1.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138854","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}
引用次数: 0
The effect of plasma donation frequency on total serum protein, immunoglobulin G and donor safety: A non-inferiority randomized controlled trial. 血浆捐献频率对血清总蛋白、免疫球蛋白G和献血者安全性的影响:一项非劣效性随机对照试验。
IF 1.6 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-28 DOI: 10.1111/vox.70105
Morten Haugen, Lise Sofie Haug Nissen-Meyer, Tor A Strand, Karin Magnussen

Background and objectives: The safety of varying plasma donation frequencies remains unclear. This non-inferiority randomized controlled trial investigated the effect of plasma donation frequency on total serum protein (TSP), immunoglobulin G (IgG) concentrations, additional biomarkers, adverse events (AEs) and psychological distress.

Materials and methods: In this trial, 120 male donors were randomized into three groups: high-frequency plasma donors (HFPDs, three times every 2 weeks), regular-frequency plasma donors (RFPDs, once every 2 weeks) and a control group (whole blood donation every 3 months). Blood samples were collected biweekly from baseline until the last donation in Week 16 and 4 weeks after the last donation.

Results: HFPDs completed median (range) 21.5 (1-24), RFPDs 8 (1-8) and controls 2 (1-2) donations. HFPDs had lower concentrations of TSP and IgG compared to controls, with a mean difference (95% confidence interval [CI]) of -5.5 g/L (-7.4, -3.6) and -2.8 g/L (-3.8, -1.8), respectively. Within-group analysis revealed significant reductions, which increased with the frequency of donations, in TSP, IgG, IgG subclasses, immunoglobulin M (IgM), immunoglobulin A (IgA), ferritin and haemoglobin. Many of the biomarkers required more than 4 weeks to return to baseline levels. Only mild AEs were reported, and plasma donation frequency had no effect on psychological distress.

Conclusion: High- and regular-frequency plasmapheresis substantially reduces concentrations of TSP, IgG and other biomarkers, with greater reductions at higher donation frequencies. Further research is needed to assess the long-term health implications of frequent plasma donation.

背景和目的:不同血浆捐献频率的安全性尚不清楚。这项非劣效性随机对照试验研究了血浆捐献频率对血清总蛋白(TSP)、免疫球蛋白G (IgG)浓度、其他生物标志物、不良事件(ae)和心理困扰的影响。材料与方法:本试验将120名男性献血者随机分为三组:高频献血者(HFPDs,每2周3次)、高频献血者(RFPDs,每2周1次)和对照组(每3个月全血一次)。从基线开始每两周采集一次血样,直到第16周和最后一次献血后4周。结果:HFPDs完成中位(范围)21.5 (1-24),RFPDs完成8(1-8),对照组完成2(1-2)。与对照组相比,HFPDs的TSP和IgG浓度较低,平均差异(95%置信区间[CI])分别为-5.5 g/L(-7.4, -3.6)和-2.8 g/L(-3.8, -1.8)。组内分析显示,随着献血频率的增加,TSP、IgG、IgG亚类、免疫球蛋白M (IgM)、免疫球蛋白A (IgA)、铁蛋白和血红蛋白的含量显著降低。许多生物标志物需要超过4周的时间才能恢复到基线水平。只有轻度不良反应被报道,血浆捐献频率对心理困扰没有影响。结论:高频和高频血浆置换可显著降低血清TSP、IgG等生物标志物的浓度,且频率越高,降低幅度越大。需要进一步的研究来评估频繁献血对健康的长期影响。
{"title":"The effect of plasma donation frequency on total serum protein, immunoglobulin G and donor safety: A non-inferiority randomized controlled trial.","authors":"Morten Haugen, Lise Sofie Haug Nissen-Meyer, Tor A Strand, Karin Magnussen","doi":"10.1111/vox.70105","DOIUrl":"10.1111/vox.70105","url":null,"abstract":"<p><strong>Background and objectives: </strong>The safety of varying plasma donation frequencies remains unclear. This non-inferiority randomized controlled trial investigated the effect of plasma donation frequency on total serum protein (TSP), immunoglobulin G (IgG) concentrations, additional biomarkers, adverse events (AEs) and psychological distress.</p><p><strong>Materials and methods: </strong>In this trial, 120 male donors were randomized into three groups: high-frequency plasma donors (HFPDs, three times every 2 weeks), regular-frequency plasma donors (RFPDs, once every 2 weeks) and a control group (whole blood donation every 3 months). Blood samples were collected biweekly from baseline until the last donation in Week 16 and 4 weeks after the last donation.</p><p><strong>Results: </strong>HFPDs completed median (range) 21.5 (1-24), RFPDs 8 (1-8) and controls 2 (1-2) donations. HFPDs had lower concentrations of TSP and IgG compared to controls, with a mean difference (95% confidence interval [CI]) of -5.5 g/L (-7.4, -3.6) and -2.8 g/L (-3.8, -1.8), respectively. Within-group analysis revealed significant reductions, which increased with the frequency of donations, in TSP, IgG, IgG subclasses, immunoglobulin M (IgM), immunoglobulin A (IgA), ferritin and haemoglobin. Many of the biomarkers required more than 4 weeks to return to baseline levels. Only mild AEs were reported, and plasma donation frequency had no effect on psychological distress.</p><p><strong>Conclusion: </strong>High- and regular-frequency plasmapheresis substantially reduces concentrations of TSP, IgG and other biomarkers, with greater reductions at higher donation frequencies. Further research is needed to assess the long-term health implications of frequent plasma donation.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"1205-1215"},"PeriodicalIF":1.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12695444/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970967","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}
引用次数: 0
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