VCU Medical Center to lead local research of national study of a blood substitute for use in trauma cases

Landmark clinical study is designed to begin with treatment by paramedics at the injury scene

Share this story

WHAT:          Virginia Commonwealth University Medical Center will officially announce its interest in participating in a ground-breaking national clinical research study to evaluate the usefulness of a blood substitute that is given to critically injured and bleeding victims at the scene of a trauma.

VCU Medical Center is one of 20 Level I trauma centers in the country that may study PolyHeme, an oxygen-carrying blood substitute, and its ability to increase survival in critically injured and bleeding patients. Researchers will discuss the study's protocols, which call for treatment to begin before arrival at the hospital, either at the scene of the injury or in the ambulance, and continue through a 12-hour post-injury period in the hospital. 

WHEN:            Tuesday, May 4, at 10:30 a.m.

WHERE:          VCU Medical Center, Department of Emergency Medicine, 401 N. 12th St.

WHO:              •  Dr. Therese M. Duane, assistant professor, Division of
                     General & Trauma Surgery and Critical Care, and lead
                     investigator for the VCU PolyHeme trial

•   Dr. Joseph P. Ornato, professor and chair Emergency Medicine and medical director of Richmond Ambulance Authority

MORE BACKGROUND:
Researchers expect to enroll 40 patients in the VCU study. Participants will be enrolled without directly giving their permission. The trial will be conducted under federal regulations that allow clinical research in emergency settings using an exception from the requirement for informed consent. Patients may withdraw from the study at any time, by notifying the investigator.              

The researchers will conduct a series of public meetings to gauge the interest in the community's participation in the study. Pending the outcome of these meetings and final research review board approval, VCU hopes to start the study in mid-July.

According to the CDC, trauma-related injuries are a leading cause of death among Americans under 45 years old. Nearly one in five trauma victims dies as a result of his/her injuries.

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 blood transfusion is required but blood is not available. Northfield Laboratories, Inc. of Evanston, Ill, manufactures PolyHeme. For more information visit www.northfieldlabs.com