Clinical Studies of A Perfluorochemical Whole Blood Substitute (Fluosol-DA)

Abstract

After the experimental and phase one studies of our so-called "artificial blood," Fluosol-DA (20%), an emulsified mixture of perfluorodecalin and perfluorotripropylamine, were successfully completed, phase two and three clinical studies were carried out on 186 patients in Japan. The initial dose was 20 ml/Kg body weight (BW), and additional 10 ml/Kg BW doses were applied as needed. Oxygen-supplying and plasma-extending effects were established. No untoward reaction was observed in any of the 186 cases except in a case that involved long-term repeated administration. Initial studies on FLuosol-DA suggest reasonable safety; however, additional clinical trials appear warranted.