(P-BT-11) Evaluation of INTERCEPT RBC Pathogen Reduction in Combination with Irradiation

The INTERCEPT® blood system for red blood cells (RBC), using amustaline and glutathione, is being developed for the inactivation of pathogens and leukocytes in AS-1 RBC. Amustaline forms adducts with nucleic acids and inhibits replication of contaminating pathogens and leukocytes. Although previous studies showed inactivation of leukocytes in INTERCEPT pathogen-reduced (PR) RBCs, institutional practices may further require irradiation (IR) of PR RBCs. This study characterized the in vitro function of AS-1 RBC with and without PR and IR on Day 7 through 35 days of storage.

Study

Design/Methods:

Leukocyte reduced AS-1 RBCs were prepared from CPD whole blood (WB) on the day of collection. For each replicate (n=6), four ABO matched AS-1 RBCs were pooled and divided into 2 PR input units and 2 Control (C) units. Within 19hrs of WB collection, PR input AS-1 RBCs were treated with 20mM GSH/0.2mM S-303 and C were untreated and placed at 1-6°C. On Day 7 post donation one PR and one C unit from each replicate were IR using X-ray (25-50Gray) radiation (PR-IR and C-IR). Sampling for analysis of in vitro parameters was performed throughout storage for 35 days. On D35 samples were removed and rejuvenated using PIPA.

Results/Findings:

Post-PR the Hb retention and volume recovery were 95±1%. Extracellular protein was significantly reduced from 267±16 mg in C to 44±6mg in PR units. On D35 hemolysis was significantly higher in C than PR units and higher in IR units compared to non-IR units. PR resulted in lower K+ and deformability and higher ATP, glucose and p50 than C. IR (PR and C) resulted in decreased ATP, increased extracellular K+, and similar p50 compared to non-IR units (PR and C). Compared to C-IR, PR-IR units had higher levels of ATP, glucose, morphology scores, and p50. Post-rejuvenation ATP and p50 levels were also significantly higher in PR-IR compared to C-IR units (Table 1).

Conclusions:

Although IR is not expected to be required for routine use of PR RBCs, this study demonstrates that there are some differences in vitro parameters of PR-IR RBCs, including ATP and p50, however the parameters are conserved within physiologic ranges after irradiation.