title: Protocol and preliminary results of a clinical study for comparison of solvent/detergent-inactivated plasma VIP versus FFP with special consideration of the balance of hemostasis.
abstract: Solvent/detergent virus-inactivated plasma (VIP) contains markedly reduced protein S (PS) and alpha 2-antiplasmin (APL) beside other slightly decreased inhibitors. This could possibly be critical for the balance of hemostasis in diseases in which plasma inhibitors are reduced. A heterogeneous group of 14 patients with 18 plasma transfusions (12 FFP/24 VIP, 2 units per transfusion) was investigated. The patients suffered from dilution coagulopathy, liver disease, disseminated intravascular coagulation (DIC), hyperfibrinolysis, or received massive transfusions. Prothrombin fragment 1 + 2, fibrin monomers, D-Dimers, thrombin-AT III complexes, antiplasmin-plasmin complexes and fibrinogen degradation products as markers of activated coagulation (MAC) were measured. Blood samples were taken before and after plasma replacement. Significant differences between VIP and FFP should be recognized by comparing the ratio of MAC after/MAC before plasma transfusion. Patients showed an average inhibitor plasma level of AT III 51%, protein C 44%, PS 63%, and APL 52%. Only the F 1 + 2 ratio was obviously higher in the VIP group but not significantly. So the remaining MAC ratios did not show any significant difference. Our preliminary data showed no indication for a higher state of activation of coagulation in patients receiving VIP in comparison with those receiving FFP, if the VIP had the quality required. Solvent/detergent (SD) inactivation of transfusion-relevant viruses in plasma was successfully performed by Horowitz et al. [1]. The procedure leads to a partial reduction of the activity of clotting factors [2]. PS and APL are more severely affected. Therefore, treatment with VIP might activate or at least increase the activation of coagulation, especially in patients with reduced plasma inhibitors. To clarify this problem, the following disorders with the indication for plasma replacement were included in a prospective randomized study of FFP vs. VIP: massive transfusion; dilution coagulopathy; disturbance in liver synthesis; disseminated intravascular coagulation (DIC); primary hyperfibrinolysis. Low PS levels could induce hypercoagulability by reduced F VIII and FV inhibition, and low APL could induce hyperfibrinolysis by reduced plasmin inhibition.
authors.affiliation: Department of Transfusion Medicine and Hemostaseology, University Hospital Marburg, Germany.
authors.forename: K H
authors.initials: KH
authors.lastname: Beck
authors.forename: Y
authors.initials: Y
authors.lastname: Mortelmans
authors.forename: V
authors.initials: V
authors.lastname: Kretschmer
mesh_terms: D001778:Blood Coagulation Disorders / Q000097:blood / Q000628:therapy; D001780:Blood Coagulation Tests; D016913:Blood Component Transfusion; D003902:Detergents; D006487:Hemostasis; D006801:Humans; D007124:Immunoenzyme Techniques; D010949:Plasma; D012997:Solvents
chemical_list: D003902:Detergents; D012997:Solvents