In vitro evaluation of apheresis platelet and plasma products collected and stored in non-DEHP disposable sets.

IF 1.6 4区医学 Q3 HEMATOLOGY

Vox Sanguinis Pub Date : 2026-09-01 Epub Date: 2026-06-23 DOI:10.1111/vox.70318

Susanne Marschner, Caroline R Alquist, Bethany Brown, Joseph D Rice, Christina Gloor, Jeremiah Gorman, Rebecca L Sedjo, Emily Mason, Jack P Rhodes, Phillip López, Neeta Rugg, Richard Cook, Samantha E Mack

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引用次数: 0

Abstract

Background and objectives: Di(2-ethylhexyl) phthalate (DEHP) has been classified as a reproductive toxicant and endocrine disruptor and will be banned in the European Union (EU) in blood bags starting in July 2030. Alternative plasticizers are being developed, and this study is the first to report on platelets and plasma collected using investigational non-DEHP apheresis sets.

Materials and methods: Randomized, crossover collections of platelet and plasma products from identical participants in DEHP and non-DEHP sets were performed. Plasma was studied as fresh frozen plasma (FFP) and stored in non-DEHP bags. Additional plasma-only collections evaluated plasma frozen within 24 h after phlebotomy and held at room temperature for up to 24 h (PF24RT24). Platelet and plasma quality parameters were evaluated against the US Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) criteria.

Results: Platelet products (n = 33 pairs) met all FDA/EDQM standards, and in vitro parameters were within the predetermined 20% equivalency margin. FFP products (n = 33 pairs) met the EDQM criteria. Factor VIII retention after ≥30 days of frozen storage was on average 88.4%. All parameters for PF24RT24 products (n = 31 pairs) met the 20% equivalency margin after >31 days of frozen storage. No serious adverse events in study participants were reported.

Conclusion: Non-DEHP apheresis disposable sets collect transfusion-quality platelet and plasma components, supporting the phasing out of DEHP and reducing exposure to this plasticizer, without compromising participant safety and quality of the collected products.

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非dehp一次性套装收集和保存的单采血小板和血浆产品的体外评价。

背景与目的：邻苯二甲酸二（2-乙基己基）酯（DEHP）已被列为生殖毒物和内分泌干扰物，将于2030年7月起在欧盟（EU）禁止在血袋中使用。替代性增塑剂正在开发中，本研究首次报道了使用研究性非dehp单采装置收集的血小板和血浆。材料和方法：从DEHP组和非DEHP组的同一参与者中随机交叉收集血小板和血浆产品。血浆作为新鲜冷冻血浆（FFP）进行研究，并保存在非dehp袋中。额外的血浆采集评估了在采血后24小时内冷冻的血浆，并在室温下保存24小时（PF24RT24）。血小板和血浆质量参数根据美国食品和药物管理局（FDA）和欧洲药品和保健质量理事会（EDQM）标准进行评估。结果：血小板产品（n = 33对）符合FDA/EDQM的所有标准，体外参数在预定的20%等效范围内。FFP产品（n = 33对）符合EDQM标准。≥30天的冷冻保存后，因子VIII的保留率平均为88.4%。PF24RT24产品（n = 31对）冷冻31天后，所有参数均满足20%的等效余量。研究参与者未报告严重不良事件。结论：非DEHP单采一次性装置收集输注质量的血小板和血浆成分，支持逐步淘汰DEHP和减少接触这种增塑剂，而不影响参与者的安全和收集产品的质量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vox Sanguinis 医学-血液学

CiteScore

4.40

自引率

11.10%

发文量

156

审稿时长

6-12 weeks

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.