New study of blood substitute for use in trauma cases

Oct 26 2004

The Virginia Commonwealth University Medical Center launched a study Monday on an experimental blood substitute, PolyHeme, that will be given to critically injured and bleeding victims before they arrive at the hospital.

The VCU Medical Center is one of 23 Level-1 trauma centers in the country that is studying the oxygen-carrying blood substitute and its ability to increase survival in critically injured and bleeding patients. The study will compare the survival rates of patients receiving PolyHeme with those of patients who receive saline solution, the current standard of care.

The VCU study will enroll 40 patients; 20 will receive PolyHeme, the other 20 will not. The study will enroll 720 patients nationwide. Participants will be enrolled without directly giving consent at the scene, a provision allowed under federal regulations that permit certain clinical research in emergency settings without informed consent.

According to the study protocol, PolyHeme will be administered by Richmond Ambulance Authority emergency medical personnel either at the scene of the injury or in the ambulance, and will continue during a 12-hour post-injury period in the hospital. Since blood is not currently carried in ambulances, PolyHeme has the potential to address a critical, unmet medical need for an oxygen-carrying solution where blood is not available.

Individuals who do not wish to participate in the yearlong study may opt out by obtaining a bracelet from VCU. The bracelet is necessary because critically injured patients generally are not able to communicate. Individuals who do not wish to participate in the study may have a bracelet mailed to them by contacting Judy Katzen, study coordinator, by e-mail at [email protected] or by calling (804) 827-0283.

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. PolyHeme is designed to treat hemorrhagic shock where a blood transfusion is required but blood is not available.

Manufactured by Northfield Laboratories of Evanston, Ill., PolyHeme is designed to eliminate the risk of transmission of diseases like HIV and hepatitis.

This study follows a series of public meetings and community outreach efforts in the Richmond area.