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

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.