BACKGROUND

Platelet (PLT) components undergo interruption of agitation during shipment. Studies have demonstrated maintenance of PLT quality of whole blood-derived PLT concentrates during a 24-hour interruption of agitation, but data are not available for apheresis PLTs in 100 percent plasma.

STUDY DESIGN AND METHODS

Apheresis PLTs were collected with one of two commercially available separators (Amicus, Fenwal, Inc.; or Trima Accel, Gambro BCT) to provide two identical PLT products, each with approximately 3 x 10(11) to 4.5 x 10(11) PLTs. The control product was continuously agitated. The test product was subjected to a continuous 24- or 30-hour period of interrupted agitation between Day 2 and Day 3 of storage by placement in a standard shipping box at room temperature.

RESULTS

Interrupting agitation for 24 or 30 hours influenced in vitro PLT properties to various degrees. After 5 days of storage, pH levels were judged to be well maintained after 24 hours without agitation for PLTs collected with both separators (pH < 6.2, Trima [0/12] and Amicus [0/12]). The changes in other variables associated with the retention of postinfusion viability were also considered limited and acceptable in units subjected to a 24-hour interruption of agitation. After 7 days of storage including a 24-hour interruption of agitation, Trima PLTs better maintained PLT properties compared to Amicus PLTs. With a 30-hour period, both Trima and Amicus PLTs were deemed satisfactory for pH at 5 days, but not at 7 days (pH < 6.2: Day 5, Trima [0/23] and Amicus [1/22]; Day 7, Trima [5/23] and Amicus [4/17]).

CONCLUSION

Based on the retention of pH levels of at least 6.2, apheresis PLT quality was maintained for 5 days with a 24-hour and a 30-hour interruption of agitation.