• Transfusion · Jun 2013

    Randomized Controlled Trial Multicenter Study Comparative Study

    Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas.

    • Tonine Bartelmaos, Anne Chabanel, Julie Léger, Loïc Villalon, Marie Christine Gillon, Claude Rouget, Alexandra Gomola, Marie Hélène Denninger, René Tardivel, Christian Naegelen, Françoise Courtois, Laurent Bardiaux, Bruno Giraudeau, and Yves Ozier.
    • Direction Médicale, Etablissement Français du Sang, La Plaine St Denis, France.
    • Transfusion. 2013 Jun 1;53(6):1335-45.

    BackgroundThe 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.Study Design And MethodsA 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.ResultsOne-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.ConclusionCompared 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.© 2012 American Association of Blood Banks.

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