Preliminary validation of a new standard of efficacy for stored platelets

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Abstract
BACKGROUND: Platelet preparation and storage systems, unlike those for RBC, lack an objective, absolute performance criterion to determine acceptability. Recently, a criterion based on paired comparison with the radiolabeled recovery and survival of “fresh” platelets has been proposed, namely, recovery = two‐thirds and survival = half of “fresh” platelets. STUDY DESIGN AND METHODS: Eleven normal subjects donated a unit of leukoreduced apheresis platelets using a standard, approved system. They received an aliquot radiolabeled with 111In or 51Cr (random selection) 4 to 20 hours after donation and, using the other radioisotope, on Day 5 of storage. The recovery was calculated based on the injectate radioactivity. The survival was determined using the multiple‐hit model. The area under the platelet survival curve was calculated using the COST program. RESULTS: Reinfusion of platelets less than 20 hours after collection resulted in a recovery of 74.7 ± 12.3 percent and a survival time of 7.5 ± 1.1 days. Reinfusion on Day 5 resulted in a recovery of 58.2 ± 12.0 percent and a survival time of 6.9 ± 1.4 days, values that were 77.9 ± 9.5 percent and 91.8 ± 16.1 percent of the observation using “fresh” platelets, respectively. The area under the curve using Day 5 platelets was 67.8 ± 11.5 percent of that using “fresh” platelets. CONCLUSION: The proposed criterion for objective evaluation of platelet preparation and storage systems appears applicable to a commonly accepted approach, leukoreduced apheresis platelets stored in plasma for 5 days, and merits evaluation using other collection, treatment, and storage systems.