Perfluorocarbons as Blood Substitutes: The Early Years: Experience with Fluosol DA-20% in the 1980s

Abstract

Clinical testing of perfluorocarbons (PFC) as blood substitutes began in the early 1980's in the form of Fluosol DA-20% (FDA), a mixture of perfluorodecalin and perfluorotripropylamine emulsified with Pluronic F68. We have treated 55 patients (Treatment (T) = 40; Control (C) = 15) with intravenous infusions of 30 cc/kg of FDA as part of either a randomized, clinical trial or a humanitarian protocol. All patients were Jehovah's Witnesses who refused blood transfusion and were severely anemic (mean hemoglobin = 4.6 g/d). FDA successfully increased dissolved or plasma oxygen content (P1O2 in ml/dl), but not overall oxygen content (T group: P1O2 baseline = 1.01 +/- .27, P1O2 12hrs = 1.58 +/- .47 [p = < .0001, t-test]; P1O2 12 hrs: T = 1.58 +/- .47, C = 1.00 +/- .31, p = < .0002, t-test). This effect persisted for only 12 hours post infusion, and had no apparent effect on survival. FDA is an ineffective blood substitute because of low concentration and short half-life. Improved emulsion design may resolve these problems, thereby producing a more effective agent. Our discussion will include a review of our data plus a summary of other reports of FDA efficacy as a blood substitute.

Artificial Oxygen Carriers - A Critical Analysis of Current Developments

“…Fluosol DA , PFC-Emulsion der ersten Generation besteht aus 14 % Perfluordekalin, 6 % Perfluortripropylamin emulgiert mit Pluronic F68. Zu Beginn der Achtziger Jahre wurden mit Fluosol DA zahlreiche klinische Studien [11 -13] zu verbessern [12]. Auch beim Myokardinfarkt brachte die Substanz plus Standardtherapie keinen Vorteil gegenüber der Standardtherapie alleine [13].…”

A System Establishing Compatibility Profiles for Artificial Oxygen Carriers and Other Substances

“…PFD was developed to be used as red cell substitute (1,3). To determine the rate of dead leukocytes, we used flow cytometry.…”

Artificial Oxygen Carriers – a Critical Analysis

“…In 1989 Fluosol DA was approved for use as adjuvant in PCTA in the USA but later taken out of the market after general improvements of catheter technology. Clinical studies with Fluosol DA stopped by end of the 1980s since by then it had become clear that the emulsion was not able to improve survival in patients with severe anemia [12]. In myocardial infarction, too, the substance plus standard therapy had no advantage over standard therapy alone [13].…”

“…Oxygent (main constituent perfluoroctylbromide, PFOB), has been applied on several hundred patients. In phase I studies, young, healthy volunteers received 0.25-1.0 ml/kg body weight [12,16]. Recorded side effects were fever, shaking, nausea, and transient leukocytopenia and thrombocytopenia.…”

“…Fluosol DA, PFC emulsion of the first generation, contains 14% perfluorodecalin and 6% perfluorotripropylamine emulgated with pluronic F-68. Around 1980, numerous studies [11][12][13] were made with Fluosol DA. They included patients with severe anemia, myocardial infarction, or percutaneous transluminal coronary angioplasty (PTCA) treatment.…”