Cold platelets for trauma-associated bleeding: regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg".

BACKGROUND: Laboratory and clinical evidence suggest that cold-stored platelets (CS-PLTs) might be preferable to room temperature platelets (RT-PLTs) for active bleeding. Ease of prehospital use plus potential hemostatic superiority led our facility to pursue approval of CS-PLTs for actively bleeding trauma patients. STUDY DESIGN AND METHODS: From November 18, 2013, through October 8, 2015, correspondence was exchanged between our facility, the AABB, and the US Food and Drug Administration (FDA). An initial AABB variance request was for 5-day CS-PLTs without agitation. The AABB deferred its decision pending FDA approval to use our platelet (PLT) bags for CS-PLTs. On March 27, 2015, the FDA approved 3-day CS-PLTs without agitation. On October 8, 2015, the AABB approved 3-day CS-PLTs without agitation and without bacterial testing for actively bleeding trauma patients. Our facility's goal is to carry CS-PLTs on air ambulances. RESULTS: CS-PLTs have been used for trauma patients at our facility since October 2015. As of August 2016, a total of 21 (19.1%) of 119 CS-PLTs have been transfused. The short 3-day storage period combined with the formation of clots in plasma-rich CS-PLTs during storage have been the major causes of a high (80.9%) discard rate. CONCLUSION: In the future, pathogen-reduced (PR), PLT additive solution (PAS) CS-PLTs seem more practical due to low risks of bacterial contamination and storage-related clotting. This should make longer storage of CS-PLTs feasible (e.g., 10 days or more). With a longer shelf life, PR PAS CS-PLTs could potentially be used in a wider range of patient populations.

A novel source of viable peripheral blood mononuclear cells from leukoreduction system chambers.

BACKGROUND: Buffy coats are becoming less available as a source of research-grade peripheral blood mononuclear cells (PBMNCs). Therefore, alternative sources of these cells were investigated. STUDY DESIGN AND METHODS: PBMNCs isolated from the cells retained in leukoreduction system chambers (LRSCs) and those eluted from white blood cell filters were compared. From LRSCs (1.88 +/- 0.40) x 10(9) PBMNCs (n = 13) versus (0.43 +/- 0.15) x 10(9) PBMNCs were isolated from leukofilter eluates (LFEs, n = 8; p < 0.0001). RESULTS: Cells from LRSCs and LFEs produced similar numbers of burst-forming unit-erythroid, colony-forming unit (CFU)-granulocyte-macrophage, and CFU-granulocyte-erythrocyte-monocyte-macrophage-megakaryocyte colonies. The percentages of cells positive for CD3, CD4, CD8, CD14, CD19, and CD56 in the PBMNCs isolated from LRSCs and LFEs were indistinguishable. Cells isolated from LRSCs expressed higher levels of CD69 and CD25 in reaction to staphylococcal enterotoxin B than the cells isolated from LFEs. The source of cells affected neither the yield and purity of immunomagnetically isolated CD3+ cells, CD14+ cells, and CD56+ cells nor the function of T cells, natural killer cells, and in vitro matured dendritic cells (DCs). DC yield from LRSC-derived CD14+ cells, however, was higher. CONCLUSION: LRSCs are a novel source of fully functional PBMNCs that can replace the more traditional sources of research-grade cellular products.