Journal of Clinical Apheresis最新文献

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Large volume plasmapheresis using a single-use immunoadsorption column: A cost-effective approach for desensitization in ABO-incompatible liver transplant 使用一次性免疫吸附柱进行大容量血浆置换:ABO血型不合肝移植脱敏的一种成本效益高的方法。
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-05-16 DOI: 10.1002/jca.22058
Sarika Agarwal MD, DNB, Ashish Maheshwari MD, Meenu Bajpai MD
{"title":"Large volume plasmapheresis using a single-use immunoadsorption column: A cost-effective approach for desensitization in ABO-incompatible liver transplant","authors":"Sarika Agarwal MD, DNB,&nbsp;Ashish Maheshwari MD,&nbsp;Meenu Bajpai MD","doi":"10.1002/jca.22058","DOIUrl":"10.1002/jca.22058","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Liver transplant is a life-saving treatment, but due to the limited availability of suitable liver donors, ABO-incompatible liver transplants (ABOi-LT) are conducted to increase the availability of liver donors. Perioperative desensitization for ABOi-LT is an established strategy to circumvent the risk of graft rejection. A single prolonged session can be performed to achieve the desired titers to avoid using multiple immunoadsorption (IA) columns or off-label reuse of single-use columns. This study retrospectively assessed the effectiveness of a single prolonged plasmapheresis session using IA as a desensitization strategy in live donor liver transplant (LDLT).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and methods</h3>\u0000 \u0000 <p>This retrospective observational study conducted at a center for liver diseases in North India on six ABOi-LDLT patients who underwent single prolonged IA sessions in the perioperative period from January 2018 to June 2021.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Median baseline titer in patients was 320 (64, 1024). The median plasma volume adsorbed was 7.5 volumes (4, 8) per procedure, with a mean procedure time of 600 min (310-753). The reduction in titer ranged from 4 log to 7 log reduction per procedure. Two patients developed transient hypotension during the procedure, which was managed successfully. The median duration of pre-transplant hospital stay was 1.5 days (1, 3).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Desensitization therapy helps overcome the ABO barrier and decreases the waiting period before a transplant when ABO identical donors are unavailable. A single prolonged IA session reduces the cost of additional IA columns and hospital stay, thus making it a cost-effective approach to desensitization.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 5","pages":"548-554"},"PeriodicalIF":1.5,"publicationDate":"2023-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9530936","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
Neonatal Fc receptor blockade as emerging therapy in diseases with plasma exchange indications 新生儿Fc受体阻断是血浆置换适应症疾病的新兴治疗方法。
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-05-15 DOI: 10.1002/jca.22055
Muharrem Yunce MD, Nakul Katyal MD, Grace Fortes Monis MD, PhD, Srikanth Muppidi MD
{"title":"Neonatal Fc receptor blockade as emerging therapy in diseases with plasma exchange indications","authors":"Muharrem Yunce MD,&nbsp;Nakul Katyal MD,&nbsp;Grace Fortes Monis MD, PhD,&nbsp;Srikanth Muppidi MD","doi":"10.1002/jca.22055","DOIUrl":"10.1002/jca.22055","url":null,"abstract":"<p>Neonatal Fc receptor (FcRn) blockade may represent a mechanism similar to plasma exchange (PLEX) in reducing immunoglobulin levels and thus have a broad implication for apheresis practitioners. Although only efgartigimod received FDA approval for myasthenia gravis in December 2021, multiple trials are currently underway with different FcRn therapies in a varied group of IgG antibody-mediated neurological and hematological disorders which are outlined in this review. In this review we discuss FcRn's mechanism of action, and its potential use in various neurological and non-neurological diseases. In addition, we further compare the kinetics and adverse events of PLEX and FcRn blockade. We encourage apheresis practitioners to be familiar with this class of drugs in order to better understand how these two therapies can be used either standalone, or in combination with other therapies as both FcRn antagonism and PLEX improve clinical state by reducing IgG levels and pathogenic antibodies.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 5","pages":"632-640"},"PeriodicalIF":1.5,"publicationDate":"2023-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9461991","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: 2
Revisiting the benefits of isovolemic hemodilution red cell exchange for sickle cell disease 回顾等容血液稀释红细胞交换对镰状细胞病的益处。
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-24 DOI: 10.1002/jca.22054
Manasa S. Reddy, Ahmad Alkashash, Andrew Nord, Anne Tetrick
{"title":"Revisiting the benefits of isovolemic hemodilution red cell exchange for sickle cell disease","authors":"Manasa S. Reddy,&nbsp;Ahmad Alkashash,&nbsp;Andrew Nord,&nbsp;Anne Tetrick","doi":"10.1002/jca.22054","DOIUrl":"10.1002/jca.22054","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Isovolemic hemodilution red cell exchange (IHD-RCE) is a modified form of the standard red cell exchange (STD-RCE), intended to reduce red cell requirements in patients with sickle cell disease (SCD). This retrospective crossover analysis of nine patients aims to add to the limited existing literature on IHD-RCE and address the equipoise regarding whether the benefits of (a) decreased RBC usage per exchange and (b) increased interprocedure interval (via lower fraction of cells remaining, FCR) can be observed at the same time, in the same patient.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>At a single center, we identified 37 patients with SCD undergoing chronic RCE between 2014 and 2021. We excluded those patients who did not have at least six consecutive procedures of each type (STD- and IHD-RCE), arriving at nine patients for analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>When using greater decreases in hematocrit than previously published, we did not find that IHD-RCE resulted in any clinically apparent adverse events. We did find greater decreases in diastolic blood pressure and increases in heart rate in some patients, as compared to STD-RCE. After correcting for total blood volume, seven of the nine patients had significantly reduced red cell requirements with each IHD-RCE. Because the pattern of achieving a lower FCR than programmed was seen to an equal extent with both IHD-RCE and STD-RCE, none of the nine patients showed any statistical difference in actual FCR between procedure types.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Our data do not support the observation of both IHD-RCE benefits, decreased red cell usage per exchange and lower FCR/increased interprocedure interval, simultaneously.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 5","pages":"522-528"},"PeriodicalIF":1.5,"publicationDate":"2023-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22054","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9446316","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
Modifications to therapeutic plasma exchange to achieve rapid exchange on cardiopulmonary bypass prior to pediatric cardiac transplant 在儿童心脏移植之前,对治疗性血浆交换进行修改,以实现体外循环中的快速交换。
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-12 DOI: 10.1002/jca.22053
Emily Davies, Sairah Khan, Yunchuan D. Mo, Cyril Jacquot, Niti Dham, Pranava Sinha, Jennifer Webb
{"title":"Modifications to therapeutic plasma exchange to achieve rapid exchange on cardiopulmonary bypass prior to pediatric cardiac transplant","authors":"Emily Davies,&nbsp;Sairah Khan,&nbsp;Yunchuan D. Mo,&nbsp;Cyril Jacquot,&nbsp;Niti Dham,&nbsp;Pranava Sinha,&nbsp;Jennifer Webb","doi":"10.1002/jca.22053","DOIUrl":"10.1002/jca.22053","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Cardiac transplants increasingly occur following placement of ventricular assist devices (VADs). A strong association exists between human leukocyte antigen (HLA) sensitization and VAD placement; however, desensitization protocols that utilize therapeutic plasma exchange (TPE) are fraught with technical challenges and are at increased risk of adverse events. In response to increased VAD utilization in our pre-transplant population, we developed a new institutional standard for TPE in the operating room.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Through a multidisciplinary effort, we developed an institutional protocol for intraoperative TPE immediately prior to cardiac transplantation after cannulation onto cardiopulmonary bypass (CPB). All procedures used the standard TPE protocol on the Terumo Optia (Terumo BCT, Lakewood, CO, USA), but incorporated multiple modifications to limit patients' bypass times, and to coordinate with the surgical teams. These modifications included deliberate misidentification of replacement fluid and maximization of the citrate infusion rate.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>These adjustments allowed the machine to run at maximal inlet speeds, minimizing duration of TPE. To date, 11 patients have been treated with this protocol. All survived their cardiac transplantation operation. Hypocalcemia and hypotension were noted; however, none of these adverse events appeared to have clinical impact. Technical complications included unexpected fibrin deposition in the TPE circuit and air in the inlet line due to surgical manipulation of the CPB cannula. No thromboembolic complications occurred in any patient.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>We feel that this procedure can be rapidly and safely performed in HLA sensitized pediatric patients on CPB to limit the risk of antibody mediated rejection of their heart transplant.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 5","pages":"514-521"},"PeriodicalIF":1.5,"publicationDate":"2023-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22053","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9657692","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
Single center experience of therapeutic plasma exchange in a resource-constrained setting: A study of trends in scope and complications 在资源受限的情况下,治疗性血浆交换的单中心经验:范围和并发症趋势的研究
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-08 DOI: 10.1002/jca.22052
Prashant Pandey, Divya Setya, Arghyadeep Marik, Shweta Ranjan, Supriya Kumari, Saikat Mandal, Praveen Kumar
{"title":"Single center experience of therapeutic plasma exchange in a resource-constrained setting: A study of trends in scope and complications","authors":"Prashant Pandey,&nbsp;Divya Setya,&nbsp;Arghyadeep Marik,&nbsp;Shweta Ranjan,&nbsp;Supriya Kumari,&nbsp;Saikat Mandal,&nbsp;Praveen Kumar","doi":"10.1002/jca.22052","DOIUrl":"10.1002/jca.22052","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Therapeutic apheresis procedures are becoming an increasingly integral part of modern medical practice, be it as a part of therapy or pre-conditioning regimes for solid organ transplants. In our center, we follow the American Society for Apheresis (ASFA) guidelines for categorizing these procedures. However, lack of a centralized registry for therapeutic apheresis in India, lack of consolidated data as well as a resource-constrained setting prevent it from being utilized to its full potential.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Study Design and Methods</h3>\u0000 \u0000 <p>This study was a retrospective analysis of therapeutic plasma exchange (TPE) procedures performed from January 2015 to October 2022 in the Department of Transfusion Medicine at a large tertiary care hospital in North India. All consecutive TPE procedures were included. Overall and specialty-wise scoring for all patients was performed. Mean scores were calculated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 1434 procedures were performed during the study duration of 7 years. These procedures were performed for 284 different patients. Majority of the procedures were referred from nephrology (895 of 1434, 62.4%), followed by neurology, gastroenterology, and liver transplant teams, hematology, critical care, rheumatology, pediatrics, and internal medicine. Complete response, partial response, and no-response were observed in 1077 (75.1%), 201 (14%), and 156 (10.9%) procedures respectively. Only 14 procedures reported adverse effects.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Increasing effectiveness of TPE in a number of procedures and a variety of indications has broadened its scope, while the small number of adverse events, when supervised by trained Transfusion Medicine physicians has made TPE a more viable and safer alternative to other treatment modalities.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 4","pages":"463-471"},"PeriodicalIF":1.5,"publicationDate":"2023-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10130150","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 efficiency of a continuous versus an intermittent apheresis method for collection of hematopoietic progenitor stem cells: A systematic review 连续采血法与间歇采血法收集造血祖干细胞的效率:系统综述
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-08 DOI: 10.1002/jca.22051
Cassandra Hobbs MN, Heidi Green MPH, PhD, Ritin Fernandez PhD
{"title":"The efficiency of a continuous versus an intermittent apheresis method for collection of hematopoietic progenitor stem cells: A systematic review","authors":"Cassandra Hobbs MN,&nbsp;Heidi Green MPH, PhD,&nbsp;Ritin Fernandez PhD","doi":"10.1002/jca.22051","DOIUrl":"10.1002/jca.22051","url":null,"abstract":"<p>Peripheral blood hematopoietic progenitor stem cells (HPSCs) are the most common source of stem cells for autologous and allogenic transplantation. Currently, systematic reviews comparing the collection efficiency of a continuous to an intermittent method are lacking despite the existence of primary studies. Therefore, the objective of this review was to synthesize the best available evidence to compare the efficiency of the continuous vs the intermittent method for the collection of hematopoietic progenitor stem cells required for HPC transplantation. A search using MEDLINE, CINAHL, EMBASE, Google scholar, and MedNar for both published and unpublished studies was conducted in December 2021. The systematic review was conducted in accordance with JBI methodology. A critical appraisal of the studies was undertaken by two independent reviewers using the JBI quasi-experimental critical appraisal checklist. A total of six studies were included in the review. The findings of this review demonstrated that there was no statistically significant difference in the collection efficiency, length of procedure time, and total blood volume processed between the continuous and intermittent programs. The evidence suggests that the continuous method is as safe and effective as the intermittent method to collect HPSCs. Until further evidence becomes available clinicians should be guided by the policies of their individual hospitals.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 4","pages":"472-480"},"PeriodicalIF":1.5,"publicationDate":"2023-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10124725","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
Special Issue Abstracts from the American Society for Apheresis 44th Annual Meeting April 26–28, 2023 美国单采学会第44届年会特刊摘要2023年4月26日至28日
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-06 DOI: 10.1002/jca.22049
{"title":"Special Issue Abstracts from the American Society for Apheresis 44th Annual Meeting April 26–28, 2023","authors":"","doi":"10.1002/jca.22049","DOIUrl":"https://doi.org/10.1002/jca.22049","url":null,"abstract":"","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 3","pages":"281-358"},"PeriodicalIF":1.5,"publicationDate":"2023-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50122436","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: 8
Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue 临床实践中使用治疗性单采指南-循证方法,来自美国单采学会写作委员会:第九特刊
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-05 DOI: 10.1002/jca.22043
Laura Connelly-Smith, Caroline R. Alquist, Nicole A. Aqui, Jan C. Hofmann, Reinhard Klingel, Oluwatoyosi A. Onwuemene, Christopher J. Patriquin, Huy P. Pham, Amber P. Sanchez, Jennifer Schneiderman, Volker Witt, Nicole D. Zantek, Nancy M. Dunbar
{"title":"Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue","authors":"Laura Connelly-Smith,&nbsp;Caroline R. Alquist,&nbsp;Nicole A. Aqui,&nbsp;Jan C. Hofmann,&nbsp;Reinhard Klingel,&nbsp;Oluwatoyosi A. Onwuemene,&nbsp;Christopher J. Patriquin,&nbsp;Huy P. Pham,&nbsp;Amber P. Sanchez,&nbsp;Jennifer Schneiderman,&nbsp;Volker Witt,&nbsp;Nicole D. Zantek,&nbsp;Nancy M. Dunbar","doi":"10.1002/jca.22043","DOIUrl":"10.1002/jca.22043","url":null,"abstract":"<p>The American Society for Apheresis (ASFA) <i>Journal of Clinical Apheresis</i> (JCA) Special Issue Writing Committee is charged with reviewing, updating, and categorizing indications for the evidence-based use of therapeutic apheresis (TA) in human disease. In the Ninth Edition, the JCA Special Issue Writing Committee has incorporated systematic review and evidence-based approaches in the grading of evidence and categorization of apheresis indications to make recommendations on the use of apheresis in a wide variety of diseases and conditions. This edition has largely maintained the general layout and concept of a fact sheet introduced in the Fourth Edition (2007). Each fact sheet succinctly summarizes the evidence for the use of TA in a specific disease or medical condition. The Ninth Edition of the JCA Special Issue comprises 91 fact sheets and 166 graded and categorized indications. This includes seven new fact sheets, nine new indications on existing fact sheets, and eight changes in the category for existing indications. The Ninth Edition of the JCA Special Issue seeks to continue to serve as a key resource that guides the utilization of TA in the treatment of human disease.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 2","pages":"77-278"},"PeriodicalIF":1.5,"publicationDate":"2023-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9311371","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: 45
Prospective, open-label, multicenter clinical study to assess the performance of a new donation system for the collection of source plasma 前瞻性、开放标签、多中心临床研究,以评估一种新的血浆源采集捐赠系统的性能
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-04-02 DOI: 10.1002/jca.22050
Emily Mason, Kati Dawson, Jack Rhodes, James Kelley, Erin Goodhue Meyer, Toby L. Simon
{"title":"Prospective, open-label, multicenter clinical study to assess the performance of a new donation system for the collection of source plasma","authors":"Emily Mason,&nbsp;Kati Dawson,&nbsp;Jack Rhodes,&nbsp;James Kelley,&nbsp;Erin Goodhue Meyer,&nbsp;Toby L. Simon","doi":"10.1002/jca.22050","DOIUrl":"10.1002/jca.22050","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Safe, efficient, and reliable innovations among donation systems are needed to meet the growing global demand for source plasma. This study assessed the ability of a new donation system to collect appropriate product weights based on the US Food and Drug Administration nomogram for source plasma collections. Procedure duration and safety endpoints were also collected.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Study Design and Methods</h3>\u0000 \u0000 <p>The Rika Plasma Donation System (Terumo BCT, Inc., Lakewood, CO) was evaluated in a prospective, open-label, multicenter study. Healthy adults meeting FDA and Plasma Protein Therapeutics Association requirements for source plasma donor eligibility were consented and enrolled in the study resulting in 124 evaluable products.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The target product collection weights (ie, including plasma and anticoagulant) by participant weight category were: 705 g (110–149 lbs), 845 g (150–174 lbs), and 900 g (≥175 lbs). The mean reported product collection weights by participant weight category were 705.0 ± 0.00, 845.0 ± 0.20, and 899.9 ± 0.31 g, respectively. The mean overall procedure time was 31.5 ± 5.41 minutes. The mean procedure times by participant weight category were 25.6 ± 3.13, 30.5 ± 4.45, and 33.7 ± 4.80 minutes, respectively. Procedure-emergent adverse events (PEAEs) occurred in five participants. All PEAEs were consistent with known risks for apheresis donation, and none were related to the donation system.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The new donation system collected the target product collection weight in 100% of evaluable products. The mean procedure collection time was 31.5 minutes. The system is a new efficient platform that consistently collects the appropriate weight of the source plasma.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 4","pages":"457-462"},"PeriodicalIF":1.5,"publicationDate":"2023-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9753796","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
Investigation on the feasibility of large-volume autologous red blood cells donation: A pilot trial in a small cohort of Chinese 大容量自体红细胞捐献的可行性研究:中国小队列的试点试验
IF 1.5 4区 医学
Journal of Clinical Apheresis Pub Date : 2023-03-23 DOI: 10.1002/jca.22048
Jinghui Wu BS, Guanyi Chen MB, Lihua Wang MB, Pan Wang BS, Yue Han BS, Lei Yang BS, Xilin Ouyang MD
{"title":"Investigation on the feasibility of large-volume autologous red blood cells donation: A pilot trial in a small cohort of Chinese","authors":"Jinghui Wu BS,&nbsp;Guanyi Chen MB,&nbsp;Lihua Wang MB,&nbsp;Pan Wang BS,&nbsp;Yue Han BS,&nbsp;Lei Yang BS,&nbsp;Xilin Ouyang MD","doi":"10.1002/jca.22048","DOIUrl":"10.1002/jca.22048","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Background&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Preoperative autologous blood donation (PAD) is used for elective surgical procedures with a predictable blood loss. But a downward trend in PAD is due to the fact that patients with preoperative whole blood donation or two-unit red cell apheresis cannot avoid receiving allogenic blood during intensive surgery. To improve the clinical application of PAD, this study explores the feasibility of large-volume autologous red blood cells (RBCs) donation by a pilot trial in a small cohort of Chinese.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;This was a single-center, prospective study and 16 male volunteers were enrolled from May to October in 2020. Each volunteer donated 627.25 ± 109.74 mL (mean ± SD) RBC with apheresis machine or manually, and received 800 mg of intravenous iron in four divided doses. Blood pressure, oxygen saturation (SpO&lt;sub&gt;2&lt;/sub&gt;), respiratory rate and heart rate were monitored throughout the procedure. The RBC count, hemoglobin (Hb) concentration, hematocrit (Hct), reticulocyte count, erythropoietin (Epo), serum iron, total iron binding capacity (TIBC), transferrin saturation, transferrin, and ferritin were dynamically detected and analyzed before and 8 weeks after blood donation.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;There was no differences in SpO&lt;sub&gt;2&lt;/sub&gt;, systolic and diastolic blood pressure before and after blood collection (&lt;i&gt;P&lt;/i&gt; ≥ .05). The heart rate and respiratory rate after donation were slightly lower than those before (&lt;i&gt;P&lt;/i&gt; &lt; .05). The level of RBC, Hb concentration and Hct fell to a nadir on Day 3 (pre-donation vs post-donation on Day 3: RBC 4.81 ± 0.36*10&lt;sup&gt;12&lt;/sup&gt; /L vs 3.65 ± 0.31, &lt;i&gt;P&lt;/i&gt; &lt; .05; Hb 148.59 ± 11.92 g/L vs 113.19 ± 10.43 g/L, &lt;i&gt;P&lt;/i&gt; &lt; .05; Hct 44.08 ± 3.06% vs 33.38 ± 2.57%, &lt;i&gt;P&lt;/i&gt; &lt; .05) and recovered to the pre-donation levels at the eighth week post donation (pre-donation vs post-donation at the eighth week: RBC 4.81 ± 0.36*10&lt;sup&gt;12&lt;/sup&gt; /L vs 4.84 ± 0.34*10&lt;sup&gt;12&lt;/sup&gt; /L, &lt;i&gt;P&lt;/i&gt; ≥ .05; Hb 148.59 ± 11.92 g/L vs 150.91 ± 11.75 g/L, &lt;i&gt;P&lt;/i&gt; ≥ .05; Hct 44.08% ± 3.06% vs 43.86 ± 3.06%, &lt;i&gt;P&lt;/i&gt; ≥ .05). Epo and the reticulocyte count reached the peak values on Days 1 and 7, respectively (Epo: D0 15.30 ± 7.47 mlU/ML vs &lt;i&gt;D1&lt;/i&gt; 43.26 ± 10.52 mlU/ML, &lt;i&gt;P&lt;/i&gt; &lt; .05; reticulocyte count: D0 0.07 ± 0.02*10&lt;sup&gt;9&lt;/sup&gt;/L vs &lt;i&gt;D7&lt;/i&gt; 0.17 ± 0.04*10&lt;sup&gt;9&lt;/sup&gt; /L, &lt;i&gt;P&lt;/i&gt; &lt; .05). The red cell net profits on Day 7, the second, fourth and eighth week postdonation were 160.39 ± 144.33 mL, 387.59 ± 128.74 mL, 530.95 ± 120.37 mL, and 614.18 ± 120.10 mL, and accounted for 27.47% ± 24.70%, 63.75% ± 24.91%, 86.20% ± 22","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"38 4","pages":"447-456"},"PeriodicalIF":1.5,"publicationDate":"2023-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22048","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9770690","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}
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