Saving Lives at Trauma Scene Goal for National Research at Miami Valley Hospital
CareFlight Teams Now Using Universally Compatible Blood Substitute
Dayton, OH - Trauma victims who are critically injured at the scene will automatically be enrolled in groundbreaking national research that began at Miami Valley Hospital (MVH) in Dayton last week to test the safety and efficacy of PolyHeme®, a universally compatible, oxygen-rich blood substitute.
The benefit of PolyHeme is its ready availability in emergency situations where large volumes of blood are required. MVH's three CareFlight medical helicopters are equipped with and are using the blood substitute in place of saline, the more common fluid used when whole blood is not accessible. MVH is the region's only Level One Trauma Center with medical helicopters.
"Trauma causes one in five deaths among Americans under age 45. Our goal is to save lives beginning immediately at the accident site. This research will prove whether early intervention with an oxygen-carrying solution to maintain hemoglobin levels can do just that," said Mary McCarthy, MD, Director of Trauma Services and principal investigator of the PolyHeme study.
MVH became the 31st hospital to join national research to prove the efficacy of PolyHeme, which is manufactured by Northfield Laboratories Inc., Evanston, Ill., from chemically modified human hemoglobin.
Currently trauma patients are given a solution such as saline at the scene or while being transported to the hospital. At the hospital they are given blood after typing and cross-matching is completed. PolyHeme requires no cross-matching making it compatible with all blood types. It could provide immediate therapy when blood is not available.
Miami Valley Hospital, under the auspices of its Institutional Review Board (IRB), conducted community notification and consultation in connection with this study, as is mandated by federal regulation. Last spring, MVH held educational forums in eight local communities to discuss enrollment in the national research.
The study is being conducted under a federal regulation which provides for an exception from informed consent requirements. People wishing to decline participation in this study may contact the MVH study coordinator, Susan Mallett, 208-5069, or by E-mail at firstname.lastname@example.org to obtain a wristband indicating non-participation.
The clinical study will determine whether PolyHeme will increase the survival of bleeding trauma patients at accident scenes. Under the study protocol, treatment will begin onboard CareFlight and continue after admission to the hospital for 12 hours after the injury was reported.
Because this is a controlled clinical study, people will not be informed whether infusions contain PolyHeme or a saline solution (sterile salt water). Saline is the current standard of care for treating blood loss.