56. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie

Vorsitz

PD Dr.

Babesiose: Nur „Hundemalaria“ oder  auch eine Gefahr für die Sicherheit von Blutkomponenten?

Prim. Univ.-Doz. Dr.

eingeladene Redner

Vortrag

Pathogen-Inaktivierungssysteme für Thrombozytenkonzentrate

Quality of methylene blue/light treated plasma using a DEHP-free bag system

Blood Components

Background Di-ethyl-hexyl-phthalate (DEHP) is currently one of the major plasticizers used in blood bags. Due to its endocrine disrupting properties European regulators decided to ban its use in medical devices. Although, the final sunset date is not yet clear, DEHP-free blood bags will be essential in Europe within the next years. In the current study the quality of Methylene blue/light treated plasma using the DEHP-free version of the THERAFLEX MB-plasma system (Macopharma) was investigated.Methods Whole blood units (500 mL) were collected into 70 mL CPD anticoagulant solution in regular, DEHP-containing bags and kept at room temperature (22±2°C) overnight. After centrifugation plasma was separated and processed within 18 h after whole blood donation. Plasma units (n=8) were connected to the DEHP-free THERAFLEX MB-Plasma disposable (REF PROSDV1, Macopharma) and MB/light treatment was done according to the instructions of the manufacturer using the Macotronic B2 illumination device with a light dose of 120 J/cm2. Plasma was then transferred through the Blueflex filter into the storage bag and frozen.Results Samples were taken before treatment (sample a), after Blueflex filtration (sample b) and after storage for 1 month (sample c) for the measurement of plasma factors showing a significant effect on the plasma factors (table 1). Coagulation times significantly increased (aPTT 7% and TT 13%) while the coagulation factors decreased significantly except for factors VII and protein S. Especially, fibrinogen (Clauss) (25%), factor V (10%), factor VIII (22%) and factor XI (18%) decreased. European guideline specifications however were hold for all plasma units. Factor VIII was &gt;70% in untreated samples (82-170%) and &gt;50% in MB/light treated samples (56-146%). The decrease of fibrinogen activity was &lt;40% (17,1%-28,6%) after MB/Light treatment.Conclusion The plasma quality of MB/light-treated plasma using the THERAFLEX MB-Plasma disposable PROSDV1 without DEHP showed the expected increase/decrease of plasma factors. Data was comparable to published data obtained for the DEHP-containing disposables.Offenlegung Interessenkonflikt: Study was sponsored by Macopharma Productions (CS).

Freier Vortrag

Bacteria elimination from plasma by methylene blue/light treatment using a DEHP-free bag system

Blood Safety

Background Di-ethyl-hexyl-phthalate (DEHP) is currently one of the major plasticizers used in blood bags. Due to its endocrine disrupting properties European regulators decided to ban its use in medical devices. Although, the final sunset date is not yet clear, DEHP-free blood bags will be essential in Europe within the next years. The bacteria elimination capacity by Methylene blue (MB)/light treatment of plasma using the DEHP-free version of the THERAFLEX MB-plasma system (Macopharma) was investigated.Methods Relevance of the THERAFLEX MB-plasma procedure steps (leukocyte depletion (Plasmaflex filtration), MB/light treatment, removal of MB and photoproducts (Blueflex filtration)) were examined for their impact on elimination of two different bacteria species (Klebsiella pneumoniae and Brevundimonas diminuta). Leukodepleted plasma was prepared from whole blood using standard blood banking technology (containing DEHP). Plasma units (n=3 for each bacteria strain) were spiked with bacteria suspension (≈ 106 CFU/mL). MB/light treatment was done according to the manufacturer&quot;s instructions (120 J/cm2, Macotronic B2 illumination device) with the DEHP-free THERAFLEX MB-Plasma system PROSDV1. Bacteria titer was determined by plating on agar plates.Results Samples were taken after spiking, Plasmaflex filtration, illumination and Blueflex filtration and the log10 reduction was calculated. K. pneumoniae was reduced by ≥ 5.7 log steps by filtration through the Plasmaflex filter. A reduction factor of at least 5.9 log steps was achieved by the entire process. B. diminuta was reduced by ≥ 2.2 log steps by Plasmaflex filtration. A further reduction below the limit of detection was achieved by subsequent irradiation and Blueflex filtration so that an overall reduction factor of at least 4.7 log steps was achieved for the entire process.Conclusion In the current study it could be demonstrated that bacteria species Klebsiella pneumoniae and Brevundimonas diminuta were efficiently removed from plasma by using the THERAFLEX MB-Plasma System PROSDV1 (non-DEHP). Due to a higher spiking concentration log reduction factors achieved in this study are even higher than formerly published for DEHP-containing THERAFLEX MB-Plasma systems.Offenlegung Interessenkonflikt: Study was sponsored by Macopharma Productions (CS).

MOA 16

Sektion Sicherheit von Blutprodukten

Sektionssitzungen

Sektion Sicherheit von Blutprodukten

Termin

Vorsitz

Programm