[Preliminary results of a prospective randomized clinical study on the comparison of solvent- and detergent-inactivated plasma (SDP-TNBT/Triton X-100) and untreated fresh-frozen plasma].

We report on preliminary results of a randomised clinical study comparing solvent/detergent-inactivated plasma to untreated FFP. Factors V, VII, VIII:C and protein S in the plasma units and in 14 patients were determined. Additionally, we measured prothrombin fragments 1,2, fibrin monomers, D-dimers, thrombin-antithrombin III, plasmin-antiplasmin complexes and fibrinogen degradation products as markers of activated coagulation (MAC), and calculated ratios of MACpost/ MACpre. One batch of SD plasma (SDP 797) with very high FVII and very low protein S seemed to produce significant changes in vivo without any clinical relevance. The bad quality of this batch could be due to virus inactivation in the early phase of large-scale routine production from a plasma pool that was too small.