title: Clotting factor activity in thawed Octaplas® LG during storage at 2-6°C for 6 days from a quality assurance point of view.
abstract: BACKGROUND
  Octaplas® LG is a second-generation solvent/detergent-treated plasma that offers an additional safety benefit by prion elimination. The stability of clotting factors of the new S/D plasma after thawing has not been investigated yet. This study intended to measure the time course of fibrinogen, FII, FV, FVII, FVIII, FIX, PC, fPS and PI through storage at 2-6°C over 6 days.
  
  
  METHODS
  We investigated 20 plasma bags (five bags per blood group) and measured fibrinogen, FII, FV, FVII, FVIII, FIX, PC, fPS and PI immediately after thawing and after 2, 4, 6, 24, 48, 72, 96, 120 and 144 h storage at 2-6°C. Five separate plasma bags were thawed and stored at 2-6°C for microbiological assessment. After 6 days samples were drawn for blood cultures that were incubated for six more days.
  
  
  RESULTS
  After 6 days FII, FIX and PC showed no significant changes. FV (-16%, p<0.001), FVII (-19%, p<0.001), FVIII (-19%, p<0.001), FXI (-13%, p<0.0001) and fPS (-4%, p<0.0007) decreased significantly. PI levels were stable at 56%. The microbiological investigation showed no bacterial contamination.
  
  
  CONCLUSIONS
  In Octaplas® LG plasma clotting factors decreased slightly through storage of 6 days. PI levels were remarkably higher and stable over time in the new Octaplas® LG. Stability of stored Octaplas® LG was limited by the decrease of FVIII to 53%, which may warrant storage up to 24h from a quality assurance point of view. This could result in reduced plasma wastage and costs for healthcare givers.
authors.affiliation: Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Germany. mareike.keller@charite.de
authors.forename: Mareike Kristina
authors.initials: MK
authors.lastname: Keller
authors.forename: Martin
authors.initials: M
authors.lastname: Krebs
authors.forename: Claudia
authors.initials: C
authors.lastname: Spies
authors.forename: Klaus-Dieter
authors.initials: KD
authors.lastname: Wernecke
authors.forename: Andrea
authors.initials: A
authors.lastname: Heger
authors.forename: Christian
authors.initials: C
authors.lastname: von Heymann
mesh_terms: D001779:Blood Coagulation Factors / Q000032:analysis*; D001793:Blood Preservation; D006801:Humans; D010949:Plasma / Q000737:chemistry*; D011786:Quality Control; D013997:Time Factors
chemical_list: D001779:Blood Coagulation Factors