Postdonation platelet counts are safe when collecting platelets with the Trima Accel using a postdonation platelet count target of ≥50,000 platelets/μL

Abstract

In December 2007, the FDA issued a guidance document recommending that apheresis cell separators be configured with a postdonation platelet count target of > or =100,000 platelets/microL. Currently, our Trima Accel apheresis cell separators are configured with a postdonation platelet count target of > or =50,000 platelets/microL. To determine the safety of our current procedure, we analyzed the postdonation platelet counts of 115 donors collected using our current procedure. All of 115 donors had postdonation platelet counts > or =100,000 platelets/microL. On the basis of predonation platelet counts, we calculated that raising the postdonation target platelet count to > or =100,000 platelets/microL would have disqualified 19 out of 225 potential platelet products. We conclude that the current postdonation platelet count target of > or =50,000 platelets/microL is safe for donors collected using the Trima Accel. Efforts to reduce the incidence of TRALI are creating challenges for the platelet supply. Increasing the postdonation platelet count target to > or =100,000 platelets/microL will reduce productivity in apheresis platelet collection and may not enhance donor safety.

Recruitment of platelets, white blood cells, and hematopoietic progenitor cells during high‐yield plateletpheresis

“…In some apheresis systems, for example the Trima Accel 5.1 with the original PLT post prediction used in this study, PLT recruitment was not considered in the algorithm that predicts PLT post , which is based only on the estimated donor blood volume, PLT pre , and the target PLT yield to predict PLT post . A recent study has suggested that such a prediction underestimates the real PLT post 7 …”

“…First, some studies suggested a recruitment of PLT during plateletpheresis, defined as a ratio more than one of the effective and the predicted PLT yield based on donor blood volume and difference between PLT pre and PLT post 5,6 . If PLTs are recruited into the donor blood circulation during apheresis, the effective PLT post will be higher than conservatively predicted, and the limit setting required by the FDA may be applied too restrictively with current algorithms 7 . There are data suggesting that PLTs are indeed recruited from the spleen during apheresis, 8 in particular based on the observation that splenectomized patients in remission from leukemia did not show such a recruitment 6 .…”