This press release contains dated information and should be used for background only.
KANSAS CITY, Kan.– The University of Kansas Hospital and the University of Kansas Medical Center have set a meeting for members of the general public to discuss the proposed clinical trial for PolyHeme, a synthetic blood product designed for use in trauma patients.
The meeting will be 7:00 p.m. Wednesday, September 21, 2005 at Battenfeld Auditorium on the southwest corner (Rainbow and Olathe Blvds.) of the University of Kansas Medical Center campus.
Attendees will hear a brief overview of the proposed clinical trial and then have a chance to ask questions. Attendees will be asked to fill out a form expressing their views on the project.
The University of Kansas Hospital (and partner the University of Kansas Medical Center) is one of a select number of Level I trauma centers in the U.S. chosen to participate in a groundbreaking national clinical trial to evaluate the safety and efficacy of PolyHeme®, a temporary oxygen-carrying red blood cell substitute, in treating critically injured and bleeding patients. Under the study protocol, treatment would begin before arrival at the hospital, either at the scene of the injury or in the ambulance, and continue during a 12-hour post injury period in the hospital.
During this study Polyheme® is compared to standard of care, saline (salt water) in the pre-hospital setting and blood in the hospital.
At the site of the injury, half of the subjects (like flipping a coin) receive Polyheme®, half receive standard care (saline). It is given by emergency medical personnel before reaching the hospital (may be up to 60 minutes).
Upon arrival to the emergency room, subjects receive Polyheme® or standard care (blood). Subjects that received Polyheme® at the emergency site continue to receive Polyheme® in the hospital instead of standard care (blood). PolyHeme® is given for up to 12 hours or 6 units of PolyHeme. Standard care (blood) will be given (if needed) after 12 hours or 6 units of PolyHeme ®. Patients who originally receive the saline solution in the field will receive standard care (blood) upon arrival to the emergency room.
Because the patients eligible for this study are unlikely to be able to provide prospective informed consent due to the extent and nature of their injuries, the study will be conducted under federal regulations that allow for clinical research in emergency settings using an exception from the requirement for informed consent. These federal regulations require the hospital and KUMC to conduct community meetings to inform the public about plans for the study and solicit public comment prior to institutional approval.
Use of this provision in a study protocol is granted by the Institutional Review Board (IRB) responsible for the initial and continuing review and approval of the research study. Such a decision is based on the finding and documentation that, amongst other things, patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unproven or unsatisfactory, obtaining informed consent is not feasible, potential risks are reasonable in relation to what is known of the condition, participation in the study could provide a direct benefit to the patients enrolled, and the research could not be practicably conducted without an exception from informed consent requirements.
The treatment under study, PolyHeme®, is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available and following in the hospital where blood is available but is not necessarily free of certain side effects. It has been studied in trauma trials in the hospital setting. PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Illinois.
If someone in the community would like to be excluded from participating in this study, an “opt out” wristband will be provided at no cost. If someone in the community is involved in a trauma and they are wearing the wristband they will not be placed in the study. Information regarding how to obtain the “opt out” wristband will be available on the KU websites: http://www.kumc.edu/polyheme/ and www.kumed.com or by calling the study coordinator, Suzanne Porras, R.N. at 913-588-3005.
If you have questions about the rights of research patients, please call the University of Kansas Medical Center Human Subjects Committee at (913) 588-1240.
Northfield Laboratories is a leading developer of a temporary oxygen-carrying red blood cell substitute. Its product, PolyHeme, has been rapidly infused in clinical trials in sufficiently large quantities to be considered well tolerated and may be useful in the treatment of large volume blood loss in trauma and surgical settings. PolyHeme requires no cross matching, making it compatible with all blood types, and available immediately and has a shelf life of over 12 months.