(P-BC-39) In Vitro Quality of Red Cell Concentrates in PAGGSM Additive Solution Produced After Cold Storage with a Whole Blood Collection Set Plasticized with Di (2-Ethylhexyl) Terephthalate

Most red blood cell (RBC) concentrates (RCC) at Canadian Blood Services are produced from whole blood (WB) stored overnight (O/N) at room temperature (RT), with processing taking place ≤24 h post-collection. Rarely, an alternate processing method is used where WB is placed in the refrigerator (1—6°C) ≤ 24 h post-collection and RCCs are produced ≤ 48h after collection. WB collection sets have long been plasticized with di(2-ethylhexyl) phthalate (DEHP). However, toxicity concerns mean DEHP use in medical devices in Europe will soon be effectively prohibited. This may affect the in vitro quality of RCCs since DEHP is known to favorably impact hemolysis and other aspects of the RBC storage lesion. Manufacturers are developing DEHP-free blood bag systems and assessing RBC additive solutions (AS) that could better preserve RBCs in the absence of DEHP, including a combination of di (2-ethylhexyl) terephthalate (DEHT) plasticizer with phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) AS. This study examined the in vitro quality of RCC produced using the delayed method from WB collected in PVC-DEHP sets with SAGM or PVC-DEHT with PAGGSM.

Study

Design/Methods:

Approximately 480 mL WB was collected into CPD in either 500 mL DEHP/SAGM (Macopharma REF LQT710X) or prototype 475 mL DEHT/PAGGSM collection sets (Macopharma REF PRORQT4-B). Leukoreduced RCC were produced using a semi-automated top/bottom process. Briefly, WB was kept at RT (18—24°C) O/N, then stored cold (1—6°C). RCC production took place at RT on day (D)2 with centrifugation at 4898 x g for 10 min on a Roto Silenta (Hettich) and extraction on a Macopress Smart Revo (Macopharma). RCC were stored refrigerated. RCC quality, including hemolysis, supernatant potassium (K⁺) and RBC deformability using Lorrca (RR Mechatronics), were measured on D43 (1 day after expiry).  Non-parametric Mood’s Median tests were used to calculate statistical significance between RCC in DEHP/SAGM (n = 27) and DEHT/PAGGSM (n = 30).

Results/Findings:

D43 results are shown in Table 1. There was no statistically significant difference in hemolysis between study arms; however, 3 RCC in the DEHT/PAGGSM arm had hemolysis that exceeds the upper hemolysis limit for current RCC cited in CAN/CSA-Z902:20 Blood and Blood Components (≤ 0.8 % in at least 90% of units tested). RBC in DEHT/PAGGSM were less deformable (lower EI_MAX) and required larger amounts of force (K_EI) to deform.

Conclusions: Although hemolysis is acceptable, it comes close to levels at which QC criteria may not be met. Deformability findings align with a similar study in RCC produced on D1 using the processing method predominantly used at Canadian Blood Services.