June 1, 2000 PITTSBURGH, May 16, 2000 - UPMC Presbyterian is one of 40 sites evaluating a blood substitute product in patients undergoing cardiac bypass surgery. The multi-center research study is a phase III trial of Oxygent™ , which was developed by Alliance Pharmaceutical Corp. as a means to reduce or eliminate the need for donor blood transfusions during surgery or other periods of acute oxygen deficit. UPMC was one of the first to enroll patients into the international trial, the results of which will determine possible U.S. Food and Drug Administration approval.
"We are happy to participate in this trial because clearly, an alternative source of blood is needed," said Bartley P. Griffith, M.D., Henry Bahnson Professor of Surgery and chief, division of cardiothoracic surgery at the University of Pittsburgh School of Medicine, and the principal investigator for the Pittsburgh site.
Each year, more than 4 million patients in the United States require between one and four units of donor blood during surgeries, totaling about 11 million units. With increasing frequency, elective surgeries are being cancelled or postponed because of shortages of donor blood. And while sophisticated screening measures are routine, they can increase the cost of obtaining donor blood and do not guarantee the safety of the supply.
A phase II trial involving more than 250 patients provided preliminary evidence of the safety of Oxygent™ and that it may be more effective in improving oxygenation within the body than a unit of fresh blood. The phase III trial will enroll 600 patients in North America and Europe.
Oxygent™ looks like milk and contains no blood or blood products. And unlike donor blood, which has a shelf-life of about six weeks, Oxygent ™ can be stored for about two years and can be used for patients of all blood types. Oxygent ™ is a perflubron emulsion that picks up oxygen from the lungs and carries it through the blood stream to the body's vital organs and tissues.
To prevent blood loss and reduce the amount of donor blood used, patients undergoing bypass surgery and other surgeries typically will have some of their blood removed before surgery, which is stored during the operation and then given back to the patient immediately after surgery. This process is called acute normovolemic hemodilution. A plasma expander is usually given to compensate for blood volume loss, but it does not replace the oxygen-carrying capacity of the withdrawn red blood cells.
Patients in the study will undergo the routine hemodilution procedure and be randomized to receive Oxygent™ intravenously during their bypass surgery or an inactive solution.
Researchers aim to determine if giving patients Oxygent™ will allow surgeons to remove more blood safely before the surgery so that more of the patient's own blood can be returned, thereby reducing or even eliminating the need for donor blood. Researchers believe that the blood substitute will deliver enough oxygen to the patient's oxygen-depleted tissues to allow the patient to bleed beyond the point that a transfusion is normally required.
"Such research has extremely important implications, as the shortage of blood has often reached crisis proportions. In addition to our participation in this clinical trial, we are actively engaged in our own laboratory research aimed at developing another safe and effective artificial blood product," added Dr. Griffith, who is also director of the University of Pittsburgh's McGowan Center for Artificial Organ Development.
A research team at the McGowan Center led by Marina V. Kameneva, Ph.D., has developed an artificial blood product called HemoMax, which is currently undergoing animal testing.
Pittsburgh's study is being coordinated by Amy Seybert, Parm.D. A number of surgeons within the department of cardiothoracic surgery are co-investigators. Patients and physicians wishing to learn more about the Oxygent™ clinical trial may call 1-800-533-UPMC (8762).
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