Clotting factor activity in thawed Octaplas® LG during storage at 2–6 °C for 6 days from a quality assurance point of view

Abstract

IntroductionOctaplas® 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 6days. Materials and methodsWe 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 144h storage at 2–6°C. Five separate plasma bags were thawed and stored at 2–6°C for microbiological assessment. After 6days samples were drawn for blood cultures that were incubated for six more days. ResultsAfter 6days 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. ConclusionsIn Octaplas® LG plasma clotting factors decreased slightly through storage of 6days. 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.