[Side effects of therapeutic plasma exchange. A controlled prospective study]

Solutions of human albumin are generally used as plasma substitutes during therapeutic plasma exchanges. The safety of 2 solutions of human albumin was evaluated in a multicentre, randomized, double-blind trial. Between June, 1984 and February, 1986, 80 patients who were undergoing plasma exchanges for the first time entered the study and were randomly assigned into 2 groups according to whether they received plasma albumin (PM) or placental albumin (PC). Each patient had 6 plasma exchanges over a 2-week period. Failure was defined as the occurrence of an untoward effect during an exchange. No significant difference in the number of failures was found between the 2 albumins (PM 23/40, PC 15/40; P = 0.07). However, when the type of adverse reaction was taken into account there was a significant difference between the two treatment groups regarding the number of febrile episodes (PM 8, PC 2; P = 0.043) and shivering fits (PM 9, PC 2; P = 0.023). Thus, the nature of the albumin has no significant influence on the overall safety of plasma exchanges, but it seems that different methods of preparation may affect the type of untoward effect observed.