title: Thrombin generation capacity is impaired in methylene-blue treated plasma compared to normal levels in single-donor fresh-frozen plasma, a licensed solvent/detergent-treated plasma (Octaplas) and a development product (Uniplas).
abstract: Impaired capacity of thrombin generation (TG) was found in single-donor fresh-frozen plasma (FFP) units subjected to medical device treatment by a combination of methylene-blue dye and subsequent white-light exposure (MB plasma, MBP) compared to normal levels in non-MB-treated single-donor FFP, the licensed plasma product Octaplas, and a product under development (Uniplas; working title) applicable independently from the recipient's blood group. This result held true for MBP units obtained from two different European sources revealing a more significant TG impairment using the local inactivation system in blood banks ("in-house") than an industrial MB treatment. Supplementation of functional fibrinogen to physiological levels did not normalise the altered TG capacity in MBP, whereas addition of Octaplas did. No clear-cut correlation between coagulation factor levels in MBP and hampered TG capacity was found, suggesting a composite effect of impairment. A thorough elucidation and evaluation regarding the possible clinical impact of these findings seems prudent.
authors.affiliation: Octapharma Pharmazeutika Produktionsges.m.b.H, Research & Development Department, Oberlaaer Strasse 235, A-1100 Vienna, Austria.
authors.forename: Katharina
authors.initials: K
authors.lastname: Pock
authors.forename: Andrea
authors.initials: A
authors.lastname: Heger
authors.forename: Sandra
authors.initials: S
authors.lastname: Janisch
authors.forename: Tor-Einar
authors.initials: TE
authors.lastname: Svae
authors.forename: Jürgen
authors.initials: J
authors.lastname: Römisch
mesh_terms: D001782:Blood Donors; D001789:Blood Group Antigens; D004791:Enzyme Inhibitors / Q000494:pharmacology*; D006801:Humans; D008027:Light; D008751:Methylene Blue / Q000494:pharmacology*; D010949:Plasma / Q000737:chemistry*; D011897:Random Allocation; D013917:Thrombin / Q000737:chemistry*; D013918:Thrombin Time / Q000379:methods; D038301:Virus Inactivation / Q000187:drug effects / Q000528:radiation effects
chemical_list: D001789:Blood Group Antigens; D004791:Enzyme Inhibitors; D013917:Thrombin; D008751:Methylene Blue