Red blood cell concentrates treated with the amustaline (S‐303) pathogen reduction system and stored for 35 days retain post‐transfusion viability: results of a two‐centre study

Abstract

Background and Objectives Pathogen reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. Materials and MethodsIn a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days. On day 35, an aliquot of 51 Cr/ 99m Tc radiolabeled RBCs was transfused. In a subgroup of 26 evaluable subjects, 24-h RBC post-transfusion recovery, mean life span, median life span (T 50 ) and life span area under the curve (AUC) were analysed.Results The mean 24-h post-transfusion recovery of Test and Control RBCs was comparable (83Á2 -5Á2 and 84Á9 -5Á9%, respectively; P = 0Á06) and consistent with the US Food and Drug Administration (FDA) criteria for acceptable RBC viability. There were differences in the T 50 between Test and Control RBCs (33Á5 and 39Á7 days, respectively; P < 0Á001), however, these were within published reference ranges of 28-35 days. The AUC (per cent surviving 9 days) for Test and Control RBCs was similar (22Á6 and 23Á1 per cent surviving cells 9 days, respectively; P > 0Á05). Following infusion of Test RBCs, there were no clinically relevant abnormal laboratory values or adverse events.Conclusion RBCs prepared using amustaline pathogen reduction meet the FDA criteria for post-transfusion recovery and are metabolically and physiologically appropriate for transfusion following 35 days of storage.

In premature infants there is no decrease in 24‐hour posttransfusion allogeneic red blood cell recovery after 42 days of storage

“…Adults included healthy individuals meeting criteria as blood donors. All had been enrolled in previously reported RBC kinetic research studies in which autologous RBCs labeled with 51 Cr were reinfused …”

“…No prior RBC kinetic studies have performed direct statistical comparisons of PTR 24 in infants and adults. This study offers this comparison by utilizing PTR 24 data from three previously reported neonatal RBC kinetic studies and from four adult RBC studies . Doing so is desirable for comparing PTR 24 results in two such markedly different subject populations with their different RBC circulatory environments .…”

“…Further, we hypothesize that PTR 24 in neonates will not decrease with increasing duration of RBC storage. To test these hypotheses, we retrospectively compared PTR 24 data from three previously reported neonatal studies with PTR 24 data from four PTR 24 adult studies …”

Infectious Screening of Blood Components: Is There Still a Need for Further Inventions?

“…The introduction of pathogen reduction technologies is becoming more and more concrete, although a complete launch of pathogen reduction technologies for all blood products, in particular for RBC, is still not foreseeable. Promising developments have been made in recent years, however, especially for RBC [6] or whole blood [7]. …”

Erratum

“…The manuscript by Cancelas et al . requires clarification with respect to the secondary testing of samples for antibodies reactive with amustaline‐treated RBCs. Because no positive samples were detected in primary screening at the study sites, no secondary testing was performed at a central reference laboratory (American Red Cross, Pomona, CA).…”