Perfluorocarbons: Knowledge Gained From Clinical Trials

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Respiratory Medicine

Background:

• Perfluorocarbons (PFCs) have been investigated since the 1960s for liquid ventilation and as blood oxygen carriers.
• Early research showed promise in animal models, but human trials yielded mixed results.
• Fluosol-DA was briefly approved for coronary angioplasty but was later removed from the market.

Purpose of the Study:

• To review the historical use and clinical development of perfluorocarbons for oxygen delivery and liquid ventilation.
• To evaluate the efficacy and safety of first and second-generation perfluorocarbons in human clinical trials.
• To identify limitations and future research directions for perfluorocarbon applications.

Main Methods:

• Review of historical research and clinical investigations of perfluorocarbons.
• Analysis of outcomes from randomized controlled human trials and early clinical investigations.
• Examination of regulatory approvals and market withdrawals of perfluorocarbon-based products.

Main Results:

• Partial liquid ventilation with PFCs showed promise in animals but failed to demonstrate benefit in human trials, with increased adverse events.
• Fluosol-DA, an approved oxygen carrier, became obsolete due to technological advancements.
• Second-generation PFCs like perflubron showed potential but were limited by dose restrictions, high oxygen requirements, and serious adverse events, leading to trial discontinuation.

Conclusions:

• Despite decades of research, perfluorocarbons have not proven safe and effective for widespread human use in oxygen delivery or liquid ventilation.
• While animal studies continue to show promise, significant hurdles remain in demonstrating human safety and efficacy.
• Continued research into novel formulations is necessary, but cautious evaluation is warranted given past adverse events.