A comparison of adverse reaction rates for PAS C versus plasma platelet units.

BACKGROUND: Plasma constituents have been implicated in some types of platelet (PLT) transfusion reactions. Leukoreduced apheresis PLTs stored in InterSol have 65% less plasma than apheresis PLTs stored in 100% plasma (PPs). This study compared transfusion reaction rates in InterSol PLTs (PLT additive solution [PAS] C) versus PPs. STUDY DESIGN AND METHODS: The study design was an open-label, nonrandomized retrospective review. Statistical methods were applied to substantiate noninferiority and superiority of PAS C compared to PP in terms of transfusion reaction rates. Adverse reactions (ARs) were categorized using the Biovigilance Component of the National Healthcare Safety Network. Active surveillance was used to monitor all transfusions, both with ARs and without ARs. RESULTS: A total of 14,005 transfusions from six study sites were included, with 9845 PP transfusions given to 2202 patients and 4160 PAS C to 1444 patients. A total of 165 ARs were reported. Percentages of transfusions with ARs were 1.37% for PPs, 0.55% for PAS C, and 1.13% overall. The relative risk (RR) for PAS C versus PPs was calculated as 0.403 with an upper confidence limit (UCL) of 0.663. Overall, ARs with the highest incidence were allergic transfusion reactions (ATRs) and febrile nonhemolytic transfusion reactions (FNHTRs), at 0.66 and 0.40% of total transfusions reported, respectively. The relative risks (UCLs) for ATRs and FNHTRs, respectively, were 0.350 (0.686) and 0.336 (0.827). CONCLUSIONS: PAS C PLTs were statistically superior and noninferior to PPs with respect to the transfusion-related AR rate. PAS C noninferiority and superiority were also demonstrated for ATRs and FNHTRs, separately.

Validation of a microbial detection system for use with ACD-A platelets with PAS III platelet additive solution.

BACKGROUND: The BacT/ALERT microbial detection system (BTA) is used for testing leukoreduced apheresis platelets (LR-AP) in plasma. Platelet additive solutions (PASs) such as InterSol (PAS III) may be used to reduce the amount of plasma transfused in LR-AP. This study evaluated the performance of the two-bottle BTA testing scheme in the recovery of seeded microorganisms from LR-AP in InterSol-plasma compared to a reference plate culture method. STUDY DESIGN AND METHODS: Hyperconcentrated, double LR-AP were collected from healthy donors; InterSol was added (65% Intersol:35% plasma), equally divided into two containers, and then inoculated with an isolate of 1 of 10 clinically relevant index organisms at two levels. Aerobic (BPA) and anaerobic (BPN) BTA bottles were inoculated with 4 mL each of the inoculated LR-AP, and blood agar plates (BAPs) for aerobic and anaerobic culture (0.5 mL each). RESULTS: Zero false-positives from 103 bottle pairs were observed. All 400 two-bottle BTA tests were positive within 24 hours, except for Propionibacterium acnes (maximum time-to-detection of 86.4 hr) and 13 of 20 pairs of Streptococcus viridans (maximum time-to-detection of 31.7 hr). Thirteen of 400 BAP two-plate tests were negative for starting bacterial concentrations of 10 colony-forming units (CFUs)/mL or less. At 40 CFUs/mL or less, BTA was 100% positive while BAP was 94% positive. CONCLUSION: Seeded organism recovery was superior in the two-bottle BTA test system compared to the two-plate BAP system using InterSol platelets (PLTs). This performance is comparable to previously published results for PLTs in plasma. The use of InterSol does not appear to have a detrimental effect on the performance of the two-bottle BTA system.

Bacterial growth kinetics in ACD-A apheresis platelets: comparison of plasma and PAS III storage.

BACKGROUND: Our objective was to determine the growth kinetics of bacteria in leukoreduced apheresis platelets (LR-AP) in a platelet (PLT) additive solution (PAS; InterSol, Fenwal, Inc.) compared to LR-AP stored in plasma. STUDY DESIGN AND METHODS: Hyperconcentrated, double-dose LR-AP were collected from healthy donors with a separator (AMICUS, Fenwal, Inc.). LR-AP were evenly divided, InterSol was added to half (65% InterSol:35% plasma [PAS]), and PLTs in autologous plasma were used for a paired control (PL). Bacteria were inoculated into each LR-AP PAS/PL pair (0.5-1.6 colony-forming units [CFUs]/mL), and bacterial growth was followed for up to 7 days. Time to the end of the lag phase, doubling times, maximum concentration (conc-max), and time to maximum concentration (time-max) were estimated. RESULTS: Streptococcus viridans did not grow to detectable levels in either PAS or PL units. The other bacteria had no significant overall difference in the conc-max (p = 0.47) or time-max (p = 0.7) between PL and PAS LR-AP; PL had a 0.14 hours faster doubling rate (p = 0.023); and PAS had a 4.7 hours shorter lag time (p = 0.016). CONCLUSION: We observed that five index organisms will grow in LR-AP stored in a 35%:65% ratio of plasma to InterSol where initial bacterial concentrations are 0.5 to 1.6 CFUs/mL. The more rapid initiation of log-phase growth for bacteria within a PAS storage environment resulted in a bacterial concentration up to 4 logs higher in the PAS units compared to the plasma units at 24 hours, but with no difference in the conc-max. This may present an early bacterial detection advantage for PAS-stored PLTs.

Collection of two units of leukoreduced RBCs from a single donation with a portable multiple-component collection system.

BACKGROUND: A portable automated component collection system that produces double (2) units of leukoreduced RBCs (DRBCs) from a single donation was evaluated. This study analyzed quality of the collected and final products, the efficacy of automated leukoreduction, and donor safety. STUDY DESIGN AND METHODS: The system was used to collect 120 DRBCs. WBCs were removed from 90 products with machine-controlled filtration. DRBCs were collected in ACD-A and stored in AS-1 for 42 days at 1 to 6 degrees C. Pre- and postprocedure donor vital signs and hematologic parameters were measured. Procedure time, product characteristics, and adverse events were also recorded. In vitro studies were performed on all products on Day 0 and at end of storage. In vivo recoveries of 28 leukoreduced and 9 nonleukoreduced products were measured on Day 42. RESULTS: Day 0 mean percentage of hemolysis for leukoreduced and nonleukoreduced units was 0.05 percent. DRBCs had residual WBC counts of less than 1 x 106 cells per unit and mean RBC recovery after filtration of 91.9 +/- 2.7 percent. Mean 24-hour recovery after infusion for leukoreduced units at end of storage was 80.9 +/- 6.9 percent and nonleukoreduced units was 77.6 +/- 5.8 percent (p> 0.05). No clinically significant changes in donor vital signs or serious adverse events were observed. CONCLUSIONS: The quality of leukoreduced RBCs collected with this portable automated component collection system met or exceeded FDA requirements. This automated system is safe and effective for collection and processing of 2 units of RBCs suitable for transfusion.