Polyheme study under way

April 29, 2005

Penn State Hershey Medical Center has begun the clinical study of PolyHeme, a universally compatible blood substitute.

"We have completed our training and administrative setup and, starting Monday (May 2), emergency response vehicles will begin to carry PolyHeme," said Robert Cherry, principal investigator and medical director, Penn State Shock Trauma. "Critically injured patients who meet the study criteria and have not opted out will be enrolled and may receive PolyHeme. We have been privileged to discuss this study with a large number of community members and remain available to talk about the study. In addition, those who want to opt out of the study can still contact us to receive the bracelets that let emergency responders know their wishes."

Under the study protocol, treatment will begin before arrival at the hospital, either at the scene of the injury or in the emergency response unit, and continue during a 12-hour, post-injury period in the hospital. Because blood presently is not carried in ambulances or helicopters, the use of PolyHeme in these settings could address an unmet medical need for an oxygen-carrying solution where blood is not available. Patients who have lost blood due to injuries will receive either PolyHeme or the current standard of treatment, saline solution. Whereas saline solution does not help to supply the body with oxygen, PolyHeme has the capacity to carry oxygen.

The study will compare the survival rate of patients receiving PolyHeme to that of patients who receive saline solution. Because the patients eligible for this study are unable to provide informed consent before receiving the study treatment 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 (21 CFR 50.24). The public education and comment period held earlier this year was a requirement under the federal regulations. PolyHeme already has been studied in trauma trials in the hospital setting. To date, about 250 patients have been enrolled in the current national study with no reportable serious adverse events.

To request a bracelet or speak with the study coordinator, Terry Novchich, e-mail PolyHeme@hmc.psu.edu or call (717) 531-5829. For more information, visit http://www.pennstatehershey.com online. PolyHeme is manufactured by Northfield Laboratories Inc. of Evanston, Ill., http://www.northfieldlabs.com

(Media Contacts)

Last Updated March 19, 2009