Coagulation function in fresh‐frozen plasma prepared with two photochemical treatment methods: methylene blue and amotosalen

Abstract

BACKGROUND:Pathogen inactivation of plasma intended for transfusion is now the standard of care in Belgium. Two methods for treatment of single plasma units are available: amotosalen plus ultraviolet A light and methylene blue plus visible light. This study compared the quality and stability of plasma treated with these two methods. STUDY DESIGN AND METHODS: Plasma units made from a pool of two ABO-matched fresh apheresis units were photochemically treated with either amotosalen (PCT-FFP) or methylene blue (MB-FFP). A total of 12 paired samples were evaluated. Plasma coagulation function was assessed at three time points: immediately after treatment, after 30 days of frozen storage, and an additional 24 hours at 4°C after thawing. Comparison between PCT-FFP and MB-FFP was assessed with the paired t test and a p value of less than 0.05 indicated statistical significance. RESULTS: Based on statistical analysis, mean levels of factor (F)II, FXII, FXIII, von Willebrand antigen, ADAMTS-13, D-dimers, and protein C were equivalent between PCT-FFP and MB-FFP for all three time points. PCT-FFP exhibited shorter mean prothrombin time, activated partial thromboplastin time (two time points), and thrombin time and higher mean levels of fibrinogen, FXI, and protein S than MB-FFP. Retention of FV, FVII, FVIII, FX, or von Willebrand factor:ristocetin cofactor in PCT-FFP was either equivalent to or higher than MB-FFP. MB-FFP contained higher mean levels of plasminogen, antithrombin, and plasmin inhibitor than PCT-FFP. Retention of F IX in MB-FFP was higher than PCT-FFP only after the 4°C storage after thawing. CONCLUSION: There is adequate preservation of therapeutic coagulation factor activities in both PCT-FFP and MB-FFP. The overall coagulation factor levels and stability of PCT-FFP were better preserved than MB-FFP.

Thrombin Generation Capacity of Methylene Blue-Treated Plasma Prepared by the Theraflex MB Plasma System

“…As published by others [3,6,24,25], some losses of the functional activities of the coagulation factors FI, FV, FVIII and FXI were found. However, the average loss did not exceed 20% for any of the investigated parameters.…”

Quality Assessment of Established and Emerging Blood Components for Transfusion

“…Osselaer et al found that losses of fibrinogen, FV, FVIII, FXI, and Protein S activities were greater for MB-FFP than AS-FFP, although the most affected proteins, fibrinogen and FVIII, still retained 70–80% of their FFP activity levels after treatment and freezing and thawing of MB-FFP. The authors noted that the mean values for all 18 plasma protein activities tested fell within normal references ranges in all cases and that ADAMTS-13 was unaffected by either PR treatment [84]. Backholer et al reported similar findings in another paired comparison in which FV, FXI, FXIII, and fibrinogen losses were significant for MB-FFP, but not for AS-FFP, by analysis of variation (ANOVA) of FFP, MB-FFP, and AS-FFP; six other coagulation factors were unaffected by either treatment [85].…”

Update on pathogen inactivation treatment of plasma, with the INTERCEPT Blood System: Current position on methodological, clinical and regulatory aspects

“…The process has been validated in blood centers to verify the performance of the PCT system under different routine operating conditions [18,19]. These centers' validations demonstrated that coagulation factor levels meet European and national standards and the product has a very good performance in routine use.…”