Clinical evaluation of red cell concentrates in non-DEHP plasticized containers compared with standard DEHP plasticized containers: A quasi-randomized observational multicentre study.

IF 1.8 4区医学 Q3 HEMATOLOGY

Vox Sanguinis Pub Date : 2025-03-24 DOI: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

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引用次数: 0

Abstract

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.

查看原文本刊更多论文

非DEHP塑化容器与标准DEHP塑化容器中红细胞浓缩物的临床评价：一项准随机观察性多中心研究。

背景和目标：从2030年7月1日起，欧盟将禁止在医疗器械中使用邻苯二甲酸二乙基己基酯（DEHP）。因此，评估非dehp采血系统替代品的性能非常重要。先前，我们报道了储存在非dehp血液容器中的磷酸盐-腺嘌呤-葡萄糖-鸟苷-盐-甘露醇（PAGGSM）中的红细胞浓缩物（RCC）与储存在盐-腺嘌呤-葡萄糖-甘露醇(SAGM)/ dehp的RCC相比，不会导致输血反应率（TRR）增加。目前的研究旨在扩展数据集并证实之前的发现。材料和方法：采用准随机观察性研究比较输血反应的数量和类型。计算TRR优势比（OR）的95%可信区间。结果：共输注BTHC/PAGGSM 7507例，DEHP/SAGM rcc 25371例，TRR分别为0.35%（0.22% ~ 0.49%）和0.20% (0.15% ~ 0.26%)，OR为1.76（1.10 ~ 2.81）。本研究和既往研究的汇总数据显示OR为1.36（0.90-2.08）。将汇集的数据限制为“可能的”、“可能的”和“确定的”等归因类别，其OR为1.09（0.66-1.81）。结论：在新数据集中观察到BTHC/PAGGSM的TRR增加，尽管在汇总两项研究的数据时，它仍然与DEHP的TRR一致。

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.