Quality and safety of fresh‐frozen plasma inactivated and leucoreduced with the Theraflex methylene blue system including the Blueflex filter: 5 years’ experience

Politis, C.; Kavallierou, L.; Hantziara, S.; Katsea, P.; Triantaphylou, V.; Richardson, Clive; Tsoutsos, Demosthenis; Anagnostopoulos, Nicolaos; Gorgolidis, G.; Ziroyannis, P.

doi:10.1111/j.1423-0410.2007.00898.x

Cited by 29 publications

(32 citation statements)

References 33 publications

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“…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.…”

Section: Discussionsupporting

confidence: 53%

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

Gravemann

Kusch

Koenig

et al. 2009

Transfus Med Hemother

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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%.

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Section: Discussionsupporting

confidence: 53%

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

Gravemann

Kusch

Koenig

et al. 2009

Transfus Med Hemother

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“…In the untreated FFP group, both non-leucodepleted and leucodepleted products were used during the reported period, and the associated adverse reactions encompassed allergic reactions, anaphylactic shocks, bacterial infections, and nonhaemolytic febrile transfusion reactions. The lower incidence of allergic reactions and non-haemolytic febrile transfusion reactions in the MB group was attributed to the early and effective removal of leucocytes as well as platelets by leucocyte filter [60].…”

Section: State Of Accreditation In Europe and Haemovigilancementioning

confidence: 98%

“…The effect of MB treatment on coagulation factors and anticoagulant proteins in plasma has been widely published and reviewed elsewhere [4,38,50,[58][59][60]. In brief, the loss of coagulation factors is mainly due to photo-oxidation of the proteins during the illumination process, and the loss caused by other steps, such as freeze-thawing, leucocyte filtration or MB removal, is negligible or limited [61], meeting phase 1 and 2 validation requirements.…”

Section: Adherance To Guidelines and Clinical Aspectsmentioning

confidence: 99%

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Main Properties of the THERAFLEX MB-Plasma System for Pathogen Reduction

Seghatchian¹,

Struff

Reichenberg

2011

Transfus Med Hemother

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Methylene blue (MB) treated plasma has been in clinical use for 18 years. The current THERAFLEX MB-Plasma has a number of improved features compared with the original Springe methodology. This overview embodies: the biochemical characteristics of MB, the mechanism of the technology, toxicology, pathogen reduction capacity, current position in clinical setting and status within Europe. The THERAFLEX MB (TMB) procedure is a robust, well standardised system lending itself to transfusion setting and meets the current guidelines. The pathogen kill power of the TMB system, like the other available technologies, is not limitless, probably in order of 6 log for most enveloped viruses and considerably less for non-enveloped ones. It does not induce either new antigen or grossly reducing the function and life span of active principle in fresh frozen plasma (FFP). The removal of the residual MB at the end of the process has the beneficial effect of reducing potential toxic impacts. Clinical haemovigilance data, so far, indicate that cell-free MB plasma is effective in all therapeutic setting requiring FFP, besides inconsistent thrombotic thrombocytopenia purpura data, without serious side-effects or toxicity. The current system is in continuous improvement e.g. regarding virus reduction range, illumination device, software used, and process integration in the blood bank setting.

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“…Methylene blue was used more than a 100 years ago against malaria in children and adults in South America and Europe [7,10,14], but it was abandoned when other treatments became available.relevant indications, mainly for the treatment of methemoglobinemia and for the prevention and treatment of ifosfamide-induced encephalopathy in cancer chemotherapy [1,16,23,32]. Other applications of MB include visualization of target tissues during surgery [15], supportive treatment of anaphylactic reactions [9,21], and pathogen inactivation in fresh frozen plasma [25,28,30]. It has even been reported to be beneficial against sepsis [5].…”

Section: Introductionmentioning

confidence: 99%

High absolute bioavailability of methylene blue given as an aqueous oral formulation

Walter‐Sack

Rengelshausen

Oberwittler

et al. 2008

Eur J Clin Pharmacol

105

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Quality and safety of fresh‐frozen plasma inactivated and leucoreduced with the Theraflex methylene blue system including the Blueflex filter: 5 years’ experience

Abstract: Methylene-blue-treated fresh-frozen plasma is safer than the untreated product even in patients who require large quantities of plasma transfusion.

Cited by 29 publications

References 33 publications

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

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

Main Properties of the THERAFLEX MB-Plasma System for Pathogen Reduction

High absolute bioavailability of methylene blue given as an aqueous oral formulation

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