Friday, August 04, 2006

PolyHeme - Disputed blood-substitute study ends
denver & the west
Disputed blood-substitute study ends
Denver Health participated in the research, which some have deemed unethical
By Karen 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 Moore, Denver Health's chief of surgery and trauma services.

Denver Health enrolled 120 patients since the study's start in 2003, said Moore, 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. Steven 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.

Moore said in the best-case scenario, positive results would lead the federal Food and Drug Administration to approve the product for use in ambulances, when a patient is losing massive amounts of blood and no whole blood is available.

The agency is more likely, he said, to call for further study.

The research elicited testimonials from patients - including the daughter of singer Hank Williams 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 - Robert Nelson of the University of Pennsylvania School of Medicine; Nancy 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 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," Moore 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 Karen Augé can be reached at 303- 820-1733 or

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