An Army initiative to test a blood substitute in San Antonio may eventually help Soldiers on the battlefield.
Brooke Army Medical Center and University Hospital will participate in a national clinical trial to evaluate the safety and usefulness of PolyHeme, an oxygen-carrying blood substitute designed to increase the survival of critically injured and bleeding patients.
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 in October 2002.
Manufactured by Northfield Laboratories Inc., of Evanston, Ill, PolyHeme 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.
In 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.
The use of PolyHeme has the potential to address a critical unmet medical need for an oxygen-carrying solution where blood is not available.
The study will compare the survival rate of patients receiving PolyHeme to those who receive saline solution, the current standard of care.
“Were excited to be included in this groundbreaking clinical trial,” said Col. Toney Baskin, an Army trauma surgeon and principal study investigator.
Trauma-related injuries are a leading cause of death among Americans under 45 years old 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,” he said. “If we can begin to treat these patients very early with an oxygen-carrying solution and keep their hemoglobin levels up, we might have 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 IRB 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 the flights bringing trauma patients to Level 1 facilities like BAMC.
PolyHeme looks like blood, but stays in a patient’s system for about 24 hours. 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.
“It can buy you time in a trauma situation, but it will not eliminate the need for blood banks,” Baskin said.
From U.S. Army
