title: Comparative biochemical studies of fresh frozen plasma and pooled solvent/detergent-treated plasma (octaplasLG®) with focus on protein S and its impact in different thrombin generation assay set-ups.
abstract: OBJECTIVE
  The solvent/detergent treatment enables effective and robust inactivation of all lipid-enveloped viruses, but also inactivates partly sensitive plasma proteins such as protein S. The aim of this study was to investigate the thrombin generation capacity of octaplasLG®, in particular focusing on the function of protein S in thrombin generation assay and the impact of assay settings.
  
  
  METHODS
  Sixteen octaplasLG®batches and 32 units of single donor fresh frozen plasma (FFP) were investigated. For protein S, both functional activity and free antigen levels were measured. Thrombin generation assay was performed using two fluorogenic tests with different triggers. Finally, rotational thromboelastometry was performed.
  
  
  RESULTS
  Mean protein S levels were lower in octaplasLG®, but a wider range of values was found for FFP. Clotting parameters and thrombin generation capacities overlapped between the two plasma groups as demonstrated using both thrombin generation assays and different triggers. Spiking studies with protein S-depleted plasma, human purified protein S or antibodies against protein S confirmed a correlation between protein S and thrombin generation capacity under specific assay conditions, especially in an assay with low tissue factor concentration.
  
  
  CONCLUSIONS
  Correlation between protein S and thrombin generation capacity was demonstrated in the TGA. Due to higher variability in protein S content in the FFP group, overlapping haemostatic potentials of the two plasma groups were found.
authors.affiliation: Octapharma Pharmazeutika Produktiosges.m.b.H, Research & Development, Vienna, Austria. andrea.heger@octapharma.com.
authors.forename: A
authors.initials: A
authors.lastname: Heger
authors.affiliation: Octapharma Pharmazeutika Produktiosges.m.b.H, Research & Development, Vienna, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Janisch
authors.affiliation: Octapharma Pharmazeutika Produktiosges.m.b.H, Research & Development, Vienna, Austria.
authors.forename: K
authors.initials: K
authors.lastname: Pock
authors.affiliation: Octapharma Pharmazeutika Produktiosges.m.b.H, Research & Development, Vienna, Austria.
authors.forename: J
authors.initials: J
authors.lastname: Römisch
mesh_terms: D001777:Blood Coagulation / Q000187:drug effects; D003902:Detergents / Q000494:pharmacology*; D006801:Humans; D010949:Plasma / Q000187:drug effects* / Q000378:metabolism; D017293:Protein S / Q000378:metabolism*; D012997:Solvents / Q000737:chemistry / Q000494:pharmacology*; D013916:Thrombelastography; D013917:Thrombin / Q000378:metabolism*
chemical_list: D003902:Detergents; D017293:Protein S; D012997:Solvents; D013917:Thrombin
keywords: 
  FFP
  ; 
  TGA
  ; S/D plasma; octaplasLG; protein S; thromboelastometry