Evaluation of the properties of components prepared and stored after holding of whole blood units for 8 and 24 hours at ambient temperature.

BACKGROUND: The capability of holding whole blood (WB) units at ambient temperature, overnight, should help in platelet (PLT) concentrate preparation logistics. We summarize the results of a study conducted in the early 1990s that compared, in particular, PLT and red blood cell (RBC) in vivo viability properties following storage after preparation after 8- and 24-hour WB hold periods. STUDY DESIGN AND METHODS: Individuals donated units of WB on two occasions. Centrifugation at 20 to 24°C to separate PLTs and additive system RBC placement at 1 to 6°C was completed 8 hours after phlebotomy or after 24 hours in randomized order. Components were not leukoreduced. Studies including in vitro biochemical and hematologic analyses and autologous in vivo RBC and PLT evaluations were conducted at two sites. RESULTS: RBC 24-hour in vivo (mean ± SD) recoveries (single-label approach), after 35 days of storage, were 79.2 ± 4.3 and 79.4 ± 3.9% (n = 9; p > 0.05), with WB holding periods of 8 and 24 hours, respectively. With 42 days of storage, recovery after a 24-hour hold was slightly less than with an 8-hour hold (72.9 ± 6.5% vs. 76.0 ± 5.4%; n = 17; p < 0.05). RBC 2,3-diphosphoglycerate acid levels were substantially less after the 24-hour hold compared to after the 8-hour hold (n = 18; p < 0.05). PLT recovery after 5 days of storage with 8- and 24-hour hold periods were similar, 51.1 ± 14.9 and 50.6 ± 17.7%, respectively (n = 18; p > 0.05). The PLT survival variable and in vitro properties reflecting storage quality also showed no significant difference. CONCLUSION: RBC and PLT in vivo variables, and most in vitro variables, were not significantly different after storage with WB holding times of 8 and 24 hours except for a slight diminution of RBC recovery with the 24-hour hold after 42 days of storage.

Production of pathogen-inactivated RBC concentrates using PEN110 chemistry: a Phase I clinical study.

BACKGROUND: Despite extensive reductions in risk, donor selection and testing cannot eliminate pathogen transmission. The objective of this study was to evaluate clinically the viability of pathogen-inactivated RBCs. STUDY DESIGN AND METHODS: Twelve healthy subjects each donated two units of blood that were handled as additive system control units or were inactivated using the PEN110 process (INACTINE, V.I. Technologies) in randomized order. PEN110, which inactivates pathogens by reacting with nucleic acid bases, was incubated with RBCs for 6 hours, followed by washing and quenching with sodium thiosulfate. Radiolabeled RBC recovery and survival determinations were undertaken after 28 days of storage; biochemical and hematologic variables were assessed over 42 days. RESULTS: After 28 days, treated units had a 24-hour double-label ((51)Cr/(99m)Tc) recovery (85.0 +/- 5.0%) that was indistinguishable from control units (85.9 +/- 2.7%); the times required for reduction of radioactivity of labeled cells to half the Day 1 activity (T(50)) were similar for both groups (treated, 31.9 +/- 8.2 days; control, 32.9 +/- 3.3 days). No deleterious effects of PEN110 treatment were found on RBC antigens tested. Treatment reduced 2,3-DPG levels by half and slightly lowered pH levels. Throughout the 42-day storage period, treated RBCs had a lower level of lactate production and a trend toward lower glucose consumption. Hemolysis remained below 1 percent; supernatant potassium and ATP levels were lower than those seen in control RBCs. CONCLUSION: PEN110-treated RBCs stored for 28 days meet all critical requirements for therapeutically useful units.