Disputed blood-substitute study ends

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http://www.denverpost.com/news/ci_4134247

Denver Health participated in the research, which some have deemed unethical

By Augé Denver Post Staff Writer

A controversial study testing a blood substitute in seriously injured patients at 32 sites - including Denver Health Medical Center - has ended. The blood substitute - PolyHeme - was used on patients who had suffered blunt trauma and had loss of blood and low blood pressure, according to Dr. Ernest , Denver Health's chief of surgery and trauma services. Denver Health enrolled 120 patients since the study's start in 2003, said , who has worked for more than a decade on PolyHeme's development. Northfield Laboratories Inc., the maker of PolyHeme, said the study reached its goal of 720 participants. Dr. Gould, Northfield's chief executive, said the study results may be ready by this fall. PolyHeme is made by extracting hemoglobin from human red-blood cells, then filtering, processing and combining it with an electrolyte solution. said that while the FDA could approve PolyHeme for emergency use based on the current study results, further study may be needed before the product can be approved for other applications. The research elicited testimonials from patients - including the daughter of singer Hank Jr. - who said they would have bled to death without PolyHeme. It also drew criticism from some in the medical community, who called it unethical. The controversy peaked four weeks ago when ABC's "20/20" aired a segment on the research. This spring, three medical ethics professors signed an open letter to boards at hospitals in the study saying the research "fails to meet ethical and regulatory standards." The three - of the University of Pennsylvania School of Medicine; King, a professor at the University of North Carolina School of Medicine; and Ken Kipnis, a medical ethics professor at the University of Hawaii - asked the hospitals to sharply alter or end the research. In the study, critically injured patients were given either PolyHeme, or the current standard treatment, saline solution, by paramedics or other emergency personnel. Since eligible patients were hemorrhaging, in shock or unconscious - and not capable of giving consent- the researchers received FDA permission

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to enroll participants in the study without their prior consent. Ambulances don't carry whole blood because it must be kept refrigerated and it is difficult to determine a patient's blood type at an accident or injury scene. Objections focused mainly on the fact that patients also got a blood substitute after arriving at the hospital, where whole blood was available. "We make efforts to contact patients' families instantly," said. "At Denver Health, virtually every family was contacted within 12 hours of arrival" at the hospital. There are about a half-dozen synthetic blood and blood-substitute products in various stages of development and testing. Staff writer Augé can be reached at 303- 820-1733 or kauge@....

This story has been corrected in this online archive. Originally, due to a reporting error, a statement attributed to Denver Health's Dr. Ernest should have said that while the FDA could approve PolyHeme for emergency use based on the current study results, further study may be needed before the product can be approved for other applications.