In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution

Abstract

Background: Platelets (PLTs) stored in additive solutions (PASs) may reduce the risk of several plasma-associated adverse transfusion reactions such as allergic reactions and potentially transfusion-associated lung injury. The objective of this study was to determine the in vitro characteristics and the in vivo radiolabeled recovery and survival of apheresis PLTs (APs) stored in a new PAS and compare the latter to Food and Drug Administration (FDA) criteria.

Study design and methods: Hyperconcentrated APs were collected from healthy subjects in a paired crossover study comparing PAS (35% plasma) and 100% plasma-stored APs (Part 1) up to 7 days and, in Part 2, to determine the in vivo recovery and survival of PAS stored AP at 5 days compared to fresh PLT controls. In vitro and in vivo assays were performed following standard methods.

Results: Sixty-six and 25 evaluable subjects successfully completed Parts 1 and 2, respectively. pH for PAS AP was maintained above 6.6 for 5 days of storage. P-selectin values were consistent with published values for commonly transfused PLT products. The PAS in vivo PLT recovery (54.3 ± 8.1%) was 86.7% of the fresh control, and survival (6.4 ± 1.3 days) was 78.0% of the fresh control, both meeting the FDA performance criteria.

Conclusion: APs stored in PAS with 35% plasma carryover maintained pH over 5 days of storage and met current FDA criteria for radiolabeled recovery and survival. The use of PAS for storage of single-donor PLTs in clinical practice represents an acceptable transfusion product that reduces the volume of plasma associated with PLT transfusion.