Clinical studies of a perfluorochemical whole blood substitute (Fluosol-DA) Summary of 186 cases.
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.
D000293:Adolescent; D000328:Adult; D000368:Aged; D001772:Blood Cell Count; D001777:Blood Coagulation; D001784:Blood Gas Analysis; D001794:Blood Pressure; D001802:Blood Substitutes / Q000008:administration & dosage; D002648:Child; D002986:Clinical Trials as Topic; D004338:Drug Combinations / Q000008:administration & dosage; D004341:Drug Evaluation; D005466:Fluorocarbons / Q000008:administration & dosage; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives; D007564:Japan; D008875:Middle Aged; D011674:Pulse
D001802:Blood Substitutes; D004338:Drug Combinations; D005466:Fluorocarbons; D006895:Hydroxyethyl Starch Derivatives; C017323:glucose, glycerol, hydroxyethyl starch, perfluorodecalin, perfluorotripropylamine, pluronic F-68, salts, yolk phospholipids drug combination