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Innovative Problem Solving for the Chemical and Pharmaceutical Industries

Oxyfluor™ was developed for HemaGen as an oxygen transport agent, for use in surgical hemodilution, trauma resuscitation, and cardiopulmonary bypass. The active agent in Oxyfluor™ is perfluorodichlorooctane (PFDCO), designed in collaboration with 3M scientists to avoid problems previously associated with intravenous infusions of perfluorochemicals. This collaborative effort resulted in the screening of over 100 perfluorochemicals prior to the selection of PFDCO as the premier candidate. Pre-clinical studies of Oxyfluor indicated that it did not cause pulmonary hyperinflation, and was readily eliminated from the liver, lung and spleen. These results were corroborated by Phase I human clinical trials in which Oxyfluor was successively administered to healthy human volunteers at dosages of 0.50 and 1.00 cc/kg of PFDCO (pure perfluorocarbon basis), with no evidence of pulmonary disorder. Subsequent surgical studies employed dosages as high as 2.00 cc/kg of PFDCO, again with no significant pulmonary side effects.

Oxyfluor's Competitive Advantages

EFFICACY Oxyfluor's oxygen content increases in direct proportion to fractional inspired oxygen content (FiO2), whereas hemoglobin saturates at low FiO2. By taking advantage of standard supplemental oxygen therapy, Oxyfluor™ can deliver twice as much oxygen to the tissues as a comparable volume of whole blood.

Oxyfluor™ transports oxygen immediately upon infusion, whereas stored blood cells do not release bound oxygen until 12 hours after transfusion.

 

SAFETY Oxyfluor™ can be heat sterilized and is completely free of viruses (AIDS, hepatitis), and other blood borne pathogens. Whole blood cannot withstand terminal heat sterilization.

Oxyfluor™ can be given to any recipient regardless of blood type, eliminating the antigenicity testing and cross matching requirements of whole blood.

Oxyfluor's perfluorochemical, PFDCO is unique in that it does not cause significant pulmonary hyperinflation and has a favorable tissue elimination profile.

 

STABILITY Oxyfluor™ can be stored at room temperature for long periods, whereas whole blood must be store refrigerated, with a maximum shelf life of 42 days.

 

PRODUCTION Oxyfluor™ is manufactured using equipement and materials commonly found in large volume parenteral (LVP) production facilities.

 

Clinical Applications of Oxyfluor™

Cardiopulmonary Bypass (CPB)
A substantial body of literature documents permanent neuropsychologic adverse events associated with CPB. Oxy in CPB.gif (12422 bytes)Psychometric testing indicates cognitive dysfunction in at least 30% of CPB patients, with another 3-4% suffering severe stroke. Current research points to gaseous microemboli (bubbles similar to those induced during the bends) and poor post-bypass cerebral blood flow as the cause of these deficits. Pre-clinical data suggest that very low dosages of perfluorocarbons improve oxygen delivery and increase the solubility of gases in blood, greatly reducing the consequences of gas embolization.

Trauma Resuscitation
Prompt restoration of blood volume and oxygen delivery are Oxy in Shock.gif (5858 bytes)the two critical requirements for resuscitation from trauma with attendant blood loss and hypovolemic shock. Currently used crystalloid solutions can satisfy volume needs, but cannot transport oxygen. Furthermore, refrigeration and cross-matching requirements prevent emergency vehicle usage of whole blood, often resulting in life threatening transfusion delays. In contrast, Oxyfluor's stability will allow administration from an emergency vehicle at the site of trauma.

Surgical Anemia
Oxyfluor™ is uniquely suited for use in surgical anemia. During surgery, acute blood loss is compensated for by infusion of Oxyfluor™, which maintains tissue oxygenation with improved perfusion. This hemodilution provides the additional advantage of reducing the percentage of red cells that might be lost during any subsequent surgical blood loss. Therefore, the use of Oxyfluor™ reduces or eliminates the need for allogeneic transfusion while providing safe, effective oxygen transport during the stress of surgery.

 

Copyright ChemVantage Consultants, LLC
July, 2002