VCU news

By Pamela DiSalvo Lepley
Division of University Relations

An experimental blood substitute called PolyHeme may improve survival of critically injured and bleeding patients when blood is needed but not available, according to findings of a recent study trial that involved 32 Level-1 trauma centers across the United States.

Trauma-related injuries are a leading cause of death in Americans under the age of 45, claiming more than 140,000 lives each year. Blood is not carried in ambulances, and no adequate alternative to blood currently exists that can be given to bleeding patients when blood is not available. PolyHeme was designed to address the need for an oxygen-carrying solution that can be administered when blood is not available.

The trial, which included the Virginia Commonwealth University Medical Center, compared the survival rate of critically injured and bleeding patients who randomly received PolyHeme, to that of patients who received the standard of care – salt water.

“PolyHeme appears to be a good alternative to blood as an oxygen carrier when blood is not available,” said Therese M. Duane, M.D., assistant professor of surgery, Division of Trauma Surgery and Critical Care and lead investigator of the VCU study.

“In trauma situations, it gives us an early option to improve oxygen carrying capacity. If the Food and Drug Administration approves this blood substitute, it may be available to patients who would otherwise die from blood loss.”

PolyHeme was studied for use in bleeding patients without early access to blood, not for use in place of blood when blood is available.

According to Duane, the VCU team found no difference in mortality between patients who received PolyHeme in the ambulance compared to those who received saline solution. There was also no difference in adverse events associated with PolyHeme. At VCU, 43 patients were enrolled in the study. There were two deaths among patients who received PolyHeme and five deaths among patients receiving the control.

The overall study enrolled 714 patients – 349 received PolyHeme, and 365 received the control. There were 46 deaths among patients who received PolyHeme and 36 deaths among those receiving the control.

The physician-investigators at each site monitored patients closely for adverse events, which include any physical or laboratory abnormality that happens to a patient in a clinical trial. The FDA defines serious adverse events (SAE) to include any adverse event that results in death, is life-threatening, keeps the patient in the hospital longer, or causes lasting disability. An SAE is not necessarily caused by the test product; control patients also have them. The most common SAEs in both test product and control groups were pneumonia, multiple organ failure and respiratory failure.

The PolyHeme was administered by Richmond Ambulance Authority emergency medical personnel either at the scene of the injury or in the ambulance, and was continued during a 12-hour post-injury period in the hospital. The study began locally in the fall of 2004 after a series of public meetings and community outreach efforts in the Richmond area. The outreach was part of an effort to inform the public that participants would be enrolled in the study without directly giving consent at the scene, a provision allowed under federal regulations that permits qualified clinical research in emergency settings without informed consent.

Because study participants included critically injured patients who were generally not able to communicate, individuals were informed that they could opt out of the study by obtaining a bracelet. Approximately 50 individuals opted out of the study in the Richmond area.

PolyHeme is a universally compatible, oxygen-carrying fluid composed of chemically modified hemoglobin derived from human blood. Hemoglobin is the oxygen-carrying component of the human red blood cell. 

According to Duane, further evaluation of the study logistics and other end point parameters other than mortality that may show differences between the groups will be examined.

The multi-centered study results were presented at the American College of Surgeons meeting earlier this month.

The national study was conducted by the manufacturer of PolyHeme, Northfield Laboratories of Evanston, Ill. For more information on the study, visit http://www.northfieldlabs.com.