Study on Blood Substitute Begins in Trauma Patients
Published February 2005
UC and University Hospital will join 25 medical centers nationwide to study the effectiveness of an oxygen-carrying blood substitute.
The $15 million clinical trial will determine whether the blood substitute, known as PolyHeme, will increase the survival of bleeding trauma patients at accident scenes. PolyHeme was approved by the U.S. Food and Drug Administration (FDA) for use on Jan. 1.
Ambulances in the Cincinnati-area communities of Colerain Township, Harrison, Harrison Township, Crosby Township, Whitewater Township and Cleves will begin carrying PolyHeme in February. Plans are also under way to introduce the study following community meetings in Covington, Ky.
Half the patients in this study will receive PolyHeme. The other half will receive saline solution (sterile salt water) that is normally given to patients with blood loss. All patients in the study will be taken to University Hospital, the only level-1 trauma center in Cincinnati, for evaluation and treatment.
"Because whole blood must be typed and cross-matched before it can be given to a patient," says UC's Donald Locasto, MD, "carrying it on ambulances is not practical."
What's more, says Dr. Locasto, associate professor of emergency medicine at UC College of Medicine and local principal investigator of the study, giving patients the wrong blood type can permanently damage their organs. PolyHeme, however, does not need to be cross-matched.
The dilemma has been that depriving the brain, heart and other vital organs of oxygen for the time it takes to transport a patient to a hospital can be equally dangerous.
Currently, ambulances in this country give saline solution to accident victims who have lost a lot of blood. Saline, however, cannot carry oxygen to injured tissues.
Since the study involves giving the blood substitute to critically injured patients who cannot give consent, UC held educational forums in 10 local communities, including one with Cincinnati City Council that was also broadcast on local public cable TV.
The study did not begin until UC and University Hospital showed they had made broad public notification and met requirements of the FDA and UC's Institutional Review Board, bodies that oversee the appropriateness and safety of clinical trials.
PolyHeme is a universally compatible, immediately available, oxygen-carrying fluid specifically designed for use in emergencies involving large-volume blood loss when whole blood is not immediately available. Manufactured from chemically modified human hemoglobin, it has been studied extensively in hospitals.
Those who do not want to participate in the study may call the local hot line, 513-558-5786, for a bracelet stating "I Decline the Northfield PolyHeme Study." For more information, e-mail the local principal investigator at PI@ucpolyheme.org or go to www.ucpolyheme.org.
The researchers will make every effort to obtain consent from patients or pa-tients' families, says Dr. Locasto. If there is an objection in advance, the patient will not be given the blood substitute.The study is sponsored by PolyHeme's manufacturer, Northfield Laboratories Inc., of Evanston, Il.