Clinical use of a human albuminoid preparation (SPPS) produced by the continuous small volume mixing (CSVM) fractionation technique.

Since the commissioning of the Scottish National Blood Transfusion Service's Protein Fractionation Centre in 1975 840 batches (in excess of 150,000 bottles) of stable purified protein solution (SPPS), prepared by the continuous small volume mixing (CSVM) method, have been used clinically. Each bottle contains approximately 400 ml of a solution of 4.3 g% total protein of which greater than 85% is albumin (mean 89%). Prekallikrein activator (PKA) estimations on the last 120 batches have revealed a mean value 8.0% +/- 6.1 with reference to the U.S.A. (B.O.B.) Reference Standard (Ref. 1). Using gel filtration techniques and UV Absorption at 280 nm approximately 7% of the albumin is in polymer form. It has been calculated that there have been in excess of 40,000 separate patient exposures. SPPS has been used in the cardiac bypass situation and in large volume plasma exchange using cell separators. Clinical colleagues consider its clinical efficacy in the management of hypovolaemic patients to be of a high order. The issue of SPPS for clinical purposes is controlled by the Regional Transfusion Centres either directly or through their peripheral blood banks. Because there is close and active liaison in the reporting of adverse reactions to routine blood transfusion, similar conditions apply to all plasma products, including SPPS. In the period under retrospective review adverse reactions to isolated bottles in two batches (3 patients) of SPPS have been reported (an incidence of 0.24% batches produced). None of these reactions was fatal and none was explained. It is concluded that the SPPS produced by our Protein Fractionation Centre, using the CSVM technique, appears to have a satisfactory record with regard to efficacy and safety.