title: In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution.
abstract: BACKGROUND
  Platelets (PLTs) stored in additive solutions (PASs) may reduce the risk of several plasma-associated adverse transfusion reactions such as allergic reactions and potentially transfusion-associated lung injury. The objective of this study was to determine the in vitro characteristics and the in vivo radiolabeled recovery and survival of apheresis PLTs (APs) stored in a new PAS and compare the latter to Food and Drug Administration (FDA) criteria.
  
  
  METHODS
  Hyperconcentrated APs were collected from healthy subjects in a paired crossover study comparing PAS (35% plasma) and 100% plasma-stored APs (Part 1) up to 7 days and, in Part 2, to determine the in vivo recovery and survival of PAS stored AP at 5 days compared to fresh PLT controls. In vitro and in vivo assays were performed following standard methods.
  
  
  RESULTS
  Sixty-six and 25 evaluable subjects successfully completed Parts 1 and 2, respectively. pH for PAS AP was maintained above 6.6 for 5 days of storage. P-selectin values were consistent with published values for commonly transfused PLT products. The PAS in vivo PLT recovery (54.3 ± 8.1%) was 86.7% of the fresh control, and survival (6.4 ± 1.3 days) was 78.0% of the fresh control, both meeting the FDA performance criteria.
  
  
  CONCLUSIONS
  APs stored in PAS with 35% plasma carryover maintained pH over 5 days of storage and met current FDA criteria for radiolabeled recovery and survival. The use of PAS for storage of single-donor PLTs in clinical practice represents an acceptable transfusion product that reduces the volume of plasma associated with PLT transfusion.
authors.affiliation: Research and Development, Terumo BCT, Inc, Lakewood, Colorado, USA. larry.j.dumont@hitchcock.org
authors.forename: Larry J
authors.initials: LJ
authors.lastname: Dumont
authors.forename: Jose A
authors.initials: JA
authors.lastname: Cancelas
authors.forename: Sharon
authors.initials: S
authors.lastname: Graminske
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Friedman
authors.forename: Ralph R
authors.initials: RR
authors.lastname: Vassallo
authors.forename: Pamela H
authors.initials: PH
authors.lastname: Whitley
authors.forename: Neeta
authors.initials: N
authors.lastname: Rugg
authors.forename: Deborah F
authors.initials: DF
authors.lastname: Dumont
authors.forename: Louise
authors.initials: L
authors.lastname: Herschel
authors.forename: Alan H
authors.initials: AH
authors.lastname: Siegal
authors.forename: Zbigniew M
authors.initials: ZM
authors.lastname: Szczepiorkowski
authors.forename: Logan
authors.initials: L
authors.lastname: Fender
authors.forename: Anna
authors.initials: A
authors.lastname: Razatos
mesh_terms: D000704:Analysis of Variance; D001792:Blood Platelets; D001793:Blood Preservation / Q000379:methods*; D002470:Cell Survival; D018592:Cross-Over Studies; D006801:Humans; D006863:Hydrogen-Ion Concentration; D047589:Leukocyte Reduction Procedures; D019999:Pharmaceutical Solutions; D010949:Plasma; D010983:Plateletpheresis; D012044:Regression Analysis
chemical_list: D019999:Pharmaceutical Solutions