Under the study protocol, treatment will begin before arrival at the hospital, either at the scene of the injury, in the ambulance or in LIFESTAR (Loyola's helicopter paramedic unit/air ambulance), and continue during a 12-hour post-injury period in the hospital. Because blood is not currently carried in ambulances, the use of the blood substitute in these settings has the potential to address a critical unmet medical need. The blood substitute would be assigned to patients on a random basis who would have a 50 percent chance of receiving the substitute vs. the current standard of treatment, which is saline solution or salt water. Loyola's protocol will be that blood substitute will be used on alternating days with saline. The study will compare the survival rate of patients receiving the blood substitute to that of patients who receive saline solution. In previous studies, the substitute has been well-tolerated.
During the clinical trial, members of the public may continue to learn about the study and provide feedback by visiting Loyola's Web site: www.luhs.org/bloodsubstitute.
Members of the public who do not want to be enrolled in the study may receive a bracelet stating "I Decline the Northfield PolyHeme Study." They may call the study hotline, (708) 327-2452 or send an e-mail to: bloodsubstitute@lumc.edu.
The study is sponsored by the blood substitute manufacturer, Northfield Laboratories Inc., based in Evanston, Ill.
Loyola's IRB, a body responsible for the initial and continuing review and approval of the research, will oversee this study. Criteria for patients to be enrolled in the
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Contact: Stephen Davidow
sdavidow@lumc.edu
708-216-8232
Loyola University Health System
27-May-2004