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Thrombin Generation Capacity of Methylene Blue-Treated Plasma Prepared by the Theraflex MB Plasma System
Ute Gravemann1, Manuela Kusch, Herbert Koenig
1DRK-Blutspendedienst NSTOB, Institut Springe, Langen, Germany.
Abstract:
BACKGROUND: Methylene blue (MB) / light treatment is a well-known procedure for the inactivation of pathogens in fresh frozen plasma (FFP). Aim of the current study was to investigate the thrombin generation (TG) characteristics and quality of MB plasma prepared by the Theraflex MB Plasma System. METHODS: Single donor plasma units (n = 18) were MB/light-treated, with sampling before and after processing. Preparation included leukocyte depletion, addition of MB pill prior to illumination, and depletion of MB and photoproducts by filtration. Different plasma parameters and TG were measured. TG additionally was determined in solvent/detergent plasma (n = 8). RESULTS: MB/light treatment significantly affected factors V, VIII and XI, which were decreased by 9-18%. While the antigen level was not affected, fibrinogen according to Clauss was decreased by 7%, correlating with a 12% prolongation of TT and RT. The total amount of free thrombin generated, given as 'area under the curve' (AUC), was comparable for untreated (93 +/- 18% of normal plasma) and MB/light-treated plasma (95 +/- 20%). Also peak thrombin concentration was not significantly affected by treatment (94 +/- 11% (untreated) vs. 96 +/- 12% (treated)). The 'time to peak' value (TTP) was 105% of normal plasma for untreated FFP and 89% for MB-treated plasma. CONCLUSION: For plasma treated with the Theraflex MB Plasma System no profound influence of MB/ light treatment on the characteristics of thrombin generation was detected. In concordance with data from the literature, coagulation factors V, VIII and XI were decreased due to MB/ light treatment. Decrease was less than 20%.
Insights
Methylene blue (MB) / light treatment effectively inactivates pathogens in fresh frozen plasma (FFP) without significantly impacting thrombin generation. This study found minimal effects on coagulation factors, ensuring plasma quality and safety.
Area of Science:
- Blood product safety
- Transfusion medicine
- Biochemistry
Background:
- Methylene blue (MB) / light treatment is established for pathogen inactivation in fresh frozen plasma (FFP).
- The Theraflex MB Plasma System is used for MB/light treatment of plasma.
- Investigating the impact of this system on thrombin generation is crucial for transfusion safety.
Purpose of the Study:
- To evaluate the thrombin generation (TG) characteristics of plasma treated with the Theraflex MB Plasma System.
- To assess the overall quality of MB-treated plasma.
- To determine the influence of MB/light treatment on key coagulation parameters.
Main Methods:
- Fresh frozen plasma (FFP) units (n=18) underwent MB/light treatment using the Theraflex system.
- Leukocyte depletion, MB addition, illumination, and MB/photoproduct filtration were performed.
- Plasma parameters and TG were measured pre- and post-treatment.
- TG was also assessed in solvent/detergent treated plasma (n=8) for comparison.
Main Results:
- Coagulation factors V, VIII, and XI decreased by 9-18%, while fibrinogen decreased by 7%.
- The total amount of thrombin generated (AUC) and peak thrombin concentration remained comparable between untreated and MB-treated plasma.
- Time to peak thrombin concentration (TTP) was reduced in MB-treated plasma.
Conclusions:
- The Theraflex MB Plasma System treatment minimally affects thrombin generation characteristics.
- Coagulation factor levels (V, VIII, XI) showed a decrease below 20% post-treatment.
- MB/light treatment appears safe for FFP, with no profound negative impact on TG.

