The University of Kansas Hospital and Medical Center is sending about 75 “opt-out” bracelets, for area residents who don’t wish to participate in the PolyHeme® trial.

The trial, which will include participants in Wyandotte, Leavenworth and Douglas Counties, will evaluate the safety and effectiveness 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.

Because the patients eligible for this study are unlikely to be in condition to provide informed consent for the trial, 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.

Residents in Wyandotte, Leavenworth or Douglas Counties can request an “opt-out” bracelet at no cost at anytime during the trial. The wristband means the person desires not to participate in the study, thereby guaranteeing they would not receive Polyheme® in a trauma situation. The wristbands can be obtained through the KU websites: www.kumc.edu/polyheme/ and www.kumed.com or by calling the study coordinator, Suzanne Porras, R.N. at (913) 588-3005.