Tatiana Stephenson, Anita Howell, Carly Olafson, Chryslain Sumian, Stefan Reichenberg, Quentin Brebant, Ken McTaggart, Geraldine M Walsh
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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":""},"PeriodicalIF":1.6000,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\":null,\"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. 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引用次数: 0
摘要
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。
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.
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.
期刊介绍：
Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections:
1) Transfusion - Transmitted Disease and its Prevention:
Identification and epidemiology of infectious agents transmissible by blood;
Bacterial contamination of blood components;
Donor recruitment and selection methods;
Pathogen inactivation.
2) Blood Component Collection and Production:
Blood collection methods and devices (including apheresis);
Plasma fractionation techniques and plasma derivatives;
Preparation of labile blood components;
Inventory management;
Hematopoietic progenitor cell collection and storage;
Collection and storage of tissues;
Quality management and good manufacturing practice;
Automation and information technology.
3) Transfusion Medicine and New Therapies:
Transfusion thresholds and audits;
Haemovigilance;
Clinical trials regarding appropriate haemotherapy;
Non-infectious adverse affects of transfusion;
Therapeutic apheresis;
Support of transplant patients;
Gene therapy and immunotherapy.
4) Immunohaematology and Immunogenetics:
Autoimmunity in haematology;
Alloimmunity of blood;
Pre-transfusion testing;
Immunodiagnostics;
Immunobiology;
Complement in immunohaematology;
Blood typing reagents;
Genetic markers of blood cells and serum proteins: polymorphisms and function;
Genetic markers and disease;
Parentage testing and forensic immunohaematology.
5) Cellular Therapy:
Cell-based therapies;
Stem cell sources;
Stem cell processing and storage;
Stem cell products;
Stem cell plasticity;
Regenerative medicine with cells;
Cellular immunotherapy;
Molecular therapy;
Gene therapy.
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