title: Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas.
abstract: BACKGROUND
  The clinical equivalence of plasma treated to reduce pathogen transmission and untreated plasma has not been extensively studied. A clinical trial was conducted in liver transplant recipients to compare the efficacy of three plasmas.
  
  
  METHODS
  A randomized, equivalence, blinded trial was performed in four French liver transplantation centers. The three studied (fresh-frozen) plasmas were quarantine (Q-FFP), methylene blue (MB-FFP), and solvent/detergent (S/D-FFP) plasmas. The primary outcome was the volume of plasma transfused during transplantation. Secondary outcomes included intraoperative blood loss, hemostasis variables corrections, and adverse events.
  
  
  RESULTS
  One-hundred patients were randomly assigned in the MB-FFP, 96 in the S/D-FFP, and 97 in the Q-FFP groups, respectively. The median volumes of plasma transfused were 2254, 1905, and 1798 mL with MB-FFP, S/D-FFP, and Q-FFP, respectively. The three plasmas were not equivalent. MB-FFP was not equivalent to the two other plasmas, but S/D-FFP and Q-FFP were equivalent. The median numbers of transfused plasma units were 10, 10, and 8 units with MB-FFP, S/D-FFP, and Q-FFP, respectively. Adjustment on bleeding risk factors diminished the difference between groups: the excess plasma volume transfused with MB-FFP compared to Q-FFP was reduced from 24% to 14%. Blood loss and coagulation factors corrections were not significantly different between the three arms.
  
  
  CONCLUSIONS
  Compared to both Q-FFP and S/D-FFP, use of MB-FFP was associated with a moderate increase in volume transfused, partly explained by a difference in unit volume and bleeding risk factors. Q-FFP was associated with fewer units transfused than either S/D-FFP or MB-FFP.
authors.affiliation: Direction Médicale, Etablissement Français du Sang, La Plaine St Denis, France.
authors.forename: Tonine
authors.initials: T
authors.lastname: Bartelmaos
authors.forename: Anne
authors.initials: A
authors.lastname: Chabanel
authors.forename: Julie
authors.initials: J
authors.lastname: Léger
authors.forename: Loïc
authors.initials: L
authors.lastname: Villalon
authors.forename: Marie Christine
authors.initials: MC
authors.lastname: Gillon
authors.forename: Claude
authors.initials: C
authors.lastname: Rouget
authors.forename: Alexandra
authors.initials: A
authors.lastname: Gomola
authors.forename: Marie Hélène
authors.initials: MH
authors.lastname: Denninger
authors.forename: René
authors.initials: R
authors.lastname: Tardivel
authors.forename: Christian
authors.initials: C
authors.lastname: Naegelen
authors.forename: Françoise
authors.initials: F
authors.lastname: Courtois
authors.forename: Laurent
authors.initials: L
authors.lastname: Bardiaux
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
authors.forename: Yves
authors.initials: Y
authors.lastname: Ozier
mesh_terms: D016063:Blood Loss, Surgical / Q000517:prevention & control* / Q000706:statistics & numerical data; D003902:Detergents; D004311:Double-Blind Method; D004791:Enzyme Inhibitors; D005260:Female; D006487:Hemostasis; D006801:Humans; D016014:Linear Models; D008107:Liver Diseases / Q000453:epidemiology / Q000601:surgery; D016031:Liver Transplantation; D008297:Male; D008751:Methylene Blue; D008875:Middle Aged; D010949:Plasma; D011183:Postoperative Complications / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D011790:Quarantine; D012307:Risk Factors; D012997:Solvents; D016896:Treatment Outcome; D014777:Virus Diseases / Q000517:prevention & control
chemical_list: D003902:Detergents; D004791:Enzyme Inhibitors; D012997:Solvents; D008751:Methylene Blue