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采用改良的ACP-215方案时输入量对去甘油红细胞中红细胞质量的影响

Impact of input volume on red cell quality in deglycerolized RBCs using a modified ACP-215 protocol.

作者信息

Howell Anita, Hill Angela, Lefresne Wanda, Dennis Brandie, Turner Tracey R, Yi Qi-Long, Olafson Carly, William Nishaka, Acker Jason P

机构信息

Innovation and Portfolio Management, Canadian Blood Services, Edmonton, Alberta, Canada.

Supply Chain Process Management, Canadian Blood Services, Dartmouth, Nova Scotia, Canada.

出版信息

Transfusion. 2025 Jan;65(1):194-201. doi: 10.1111/trf.18088. Epub 2024 Dec 8.

Abstract

BACKGROUND

The ACP 215 automated cell processor is used to glycerolize and deglycerolize red cell concentrates (RCCs). Its primary advantage over the COBE 2991, previously used to cryopreserve RCCs, is that it maintains a closed system enabling extended post-thaw expiry. However, it was observed that post-deglycerolization hematocrits (Hct) of units processed with the LN236 kit are markedly lower than those processed using the COBE 2991. Therefore, we intended to determine whether a modified process using a smaller volume deglycerolization kit (LN235) could increase the final Hct with limited deleterious effects on product characteristics.

STUDY DESIGN AND METHODS

Two proof-of-concept (POC) studies, conducted to determine the feasibility of using the LN235 processing kit for deglycerolization, identified the necessary modifications to the pre- and post-deglycerolization process, after which a two-part study characterized the modified protocol. The impact of pre-cryopreservation storage duration (7-21 days), input red cell mass, and the type of CPD/SAGM RCC production method (red cell filtration and whole blood filtration) were investigated.

RESULTS

Using the LN235 kit in conjunction with a volume reduction step for RCCs with a red cell mass exceeding 180 mL allowed for an ~8% increase in Hct. As expected, slightly lower recoveries were seen for large RCCs due to volume reduction; however, there were no other detrimental outcomes on product quality.

CONCLUSIONS

Leveraging the LN235 kit, recommended by Haemonetics for units with a red cell mass of ≤180 mL, can be used to increase the post-deglycerolization Hct of RCCs that exceed this volume.

摘要

背景

ACP 215自动化细胞处理仪用于对红细胞浓缩液(RCC)进行甘油化和去甘油化处理。与之前用于冷冻保存RCC的COBE 2991相比,其主要优势在于它能保持封闭系统,从而延长解冻后的有效期。然而,有人观察到,使用LN236试剂盒处理的单位去甘油化后的血细胞比容(Hct)明显低于使用COBE 2991处理的结果。因此,我们打算确定使用体积更小的去甘油化试剂盒(LN235)的改良方法是否能提高最终Hct,同时对产品特性的有害影响有限。

研究设计与方法

进行了两项概念验证(POC)研究,以确定使用LN235处理试剂盒进行去甘油化的可行性,确定了去甘油化前后过程的必要修改,之后进行了一项分为两部分的研究,对改良方案进行了表征。研究了冷冻保存前的储存时间(7 - 21天)、输入的红细胞量以及CPD/SAGM RCC生产方法的类型(红细胞过滤和全血过滤)的影响。

结果

对于红细胞量超过180 mL的RCC,将LN235试剂盒与体积减少步骤结合使用可使Hct提高约8%。正如预期的那样,由于体积减少,大体积RCC的回收率略低;然而,对产品质量没有其他有害影响。

结论

利用Haemonetics推荐的用于红细胞量≤180 mL单位的LN235试剂盒,可用于提高超过该体积的RCC去甘油化后的Hct。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6efc/11747085/0aadb35a1799/TRF-65-194-g002.jpg

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