The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables
Article first published online: 24 MAY 2010
© 2010 The Author(s). Vox Sanguinis © 2010 International Society of Blood Transfusion
Volume 99, Issue 3, pages 232–238, October 2010
How to Cite
Lawrie, A. S., Green, L., Canciani, M. T., Mackie, I. J., Peyvandi, F., Scully, M. A. and Machin, S. J. (2010), The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables. Vox Sanguinis, 99: 232–238. doi: 10.1111/j.1423-0410.2010.01346.x
- Issue published online: 14 SEP 2010
- Article first published online: 24 MAY 2010
- Received: 25 February 2010, revised 14 April 2010, accepted 17 April 2010, published online 24 May 2010
- endogenous thrombin potential;
- fresh-frozen plasma;
- prion reduction;
- S/D plasma;
- thrombin generation test
Background Octapharma PPGmbH has recently modified its manufacturing process for solvent/detergent-treated plasma to incorporate a prion reduction step, in which a 3 log reduction has been demonstrated. The current study was undertaken to assess the impact of this procedure on haemostatic variables in the new product OctaplasLG in comparison with standard Octaplas.
Methods Production batches of standard Octaplas (n = 4) and OctaplasLG (n = 16) were assessed for levels of coagulation factors, physiological protease inhibitors, markers of activation and procoagulant microparticles. Global haemostasis was assessed by a thrombin generation test (TGT) and rotational thromboelastometry (ROTEM).
Results Mean levels of factors: II, V, VII, IX, X, XI, XII and XIII, VWF:Ag, antithrombin, protein C and free protein S were all > 75 u/dl. ADAMTS-13 activity levels were normal. Factor VIII and VWF:RCo were > 55 u/dl. TGT and ROTEM were similar in both preparations, and microparticles were present at negligible levels. Two units of OctaplasLG had slightly elevated levels of Prothrombin Fragments 1 + 2, but D-Dimer and thrombin-antithrombin complexes were normal in all batches.
Conclusion These studies indicate that the affinity chromatography procedure used in OctaplasLG does not appear to adversely affect the proven haemostatic quality of Octaplas, while offering a selective reduction in the concentration of pathological prion proteins.