Brooke Army Medical Center and University Hospital are participating in a groundbreaking national clinical trial to evaluate the safety and usefulness of PolyHeme, an oxygen-carrying blood substitute, in increasing survival of 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 air ambulance, and continue during a 12-hour post injury period in the hospital.

Since blood is not presently carried in ambulances, the use of PolyHeme in these settings has the potential to address a critical unmet medical need for an oxygen-carrying solution where blood is currently not available.

The study will compare the survival rate of patients receiving PolyHeme to that of patients who receive the current standard of care, which is saline solution.

�We are excited to be included in this groundbreaking clinical trial,� said Col. Toney Baskin, an Army trauma surgeon and the principal investigator on the study.

Trauma-related injuries are a leading cause of death among Americans under 45 according to the Centers for Disease Control and Prevention National Center for Injury Prevention and Control, Baskin said.

�Almost one in five trauma patients die from their injuries,� Baskin said. �If we can begin to treat these patients very early with an oxygen-carrying solution and keep their hemoglobin levels up, we might well see more survivors.�

Because the patients eligible for this study are unlikely to be able to provide informed consent due to the extent and nature of their injuries, the study will be conducted under

federal regulations allowing for clinical research in emergency settings using an exception from the requirement for informed consent.

Use of this provision in a study protocol is granted by the Institutional Review Board responsible for approval of the research study if the board finds that patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unsatisfactory, potential risks are reasonable, and participation in the study could provide a direct benefit to the patients enrolled.

Baskin said that San Antonio Airlife personnel would use the blood substitute. San Antonio Airlife has a paramedic and a nurse aboard each of their flights bringing trauma patients to facilities like Brooke Army Medical Center.

PolyHeme looks like blood, but only stays in a patient�s system for about 24 hours.

�It can buy you time in a trauma situation,� Baskin said. �But it will not eliminate the need for blood banks.�

He said that current research indicates the product is very safe and that there are no serious adverse events attributable to the use of PolyHeme.

PolyHeme, is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available.

PolyHeme has previously been studied in the hospital setting in trauma patients demonstrating an improved survival, according to the Journal of the American College of Surgeons, October 2002.

PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Ill. It requires no cross matching, making it immediately available and compatible with all blood types, and has an extended shelf-life of more than 12 months.

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