National research study concludes on blood substitute for use in trauma cases

By Pamela DiSalvo Lepley
Division of University Relations

RICHMOND, Va. (Aug. 1, 2006) – The Virginia Commonwealth University Medical Center, one of 32 Level-1 trauma centers in the country to participate in a study of an experimental blood substitute, PolyHeme, has been notified that the trial is closed to enrollment nationally and no more patients will be enrolled.

The trial was launched in 2004 to study the oxygen-carrying blood substitute and its ability to increase survival in critically injured and bleeding patients.

The VCU portion of the study enrolled approximately 40 patients, who randomly received either standard of care — salt water – or PolyHeme.

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. Since blood is not carried in ambulances, PolyHeme has the potential to address a critical, unmet medical need for an oxygen-carrying solution where blood is not available.

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

Now that the study is closed to further enrollment, anyone wearing an opt-out bracelet can remove it. Since Richmond ambulances no longer carry PolyHeme there is no chance that an injured person will receive it.

The national study was conducted by the manufacturer of PolyHeme, Northfield Laboratories of Evanston, Ill. In a news release issued today, the company said that the study, planned for 720 patients across the country, had completed its enrollment. The company expects top-line data from the study to be available in the fall. 

For more information on the study, visit http://www.northfieldlabs.com.

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