Northfield Laboratories, the company behind the blood substitute called Polyheme (made from chemically altered hemoglobin taken from expired units of donated blood), says mistakes in its study misclassified many study participants, so the results were not as poor as they seemed.

Dr. Andy Boggust, a site investigator for the study at Saint Marys Hospital in Rochester, said errors skewed the results. Some participants were marked as Polyheme recipients when they didn't receive it. Deaths in that group were incorrectly marked as Polyheme deaths.

"There were a lot of problems with entry into the study," Boggust said. That's actually why he thinks Polyheme looks good in the end.

After protocol violations were removed, Boggust said, only patients treated as the protocol required remained. They were called the "per-protocol" group.

Those patients did just as well as standard-therapy patients, Boggust said, leading him to favor Food and Drug Administration approval of Polyheme.

"When blood is not available for a patient, I think this is a very acceptible alternative," he said.

The product would be most useful during ambulance and air-ambulance transport, Boggust said, when the oxygen-carrying capacity of blood is needed but no blood is available.

The study

The study in question looked at 714 trauma patients nationwide who used either Polyheme or standard therapy of IV fluids. About 20 study participants with life-threatening traumatic injuries were treated at Saint Marys.

They randomly received either Polyheme or standard therapy from ambulance crews.

Widely reported study results showed disappointing results for Northfield Laboratories in May.

The study showed 13.2 percent of patients who received Polyheme died.

Deaths weren't unexpected; severely traumatized patients often die.

The FDA granted Northfield a waiver to rules that normally require informed consent before a patient can be entered in a study. That became controversial during the final days of study enrollment, but all patient slots were filled shortly thereafter.

What was unexpected? Only 9.6 percent of study participants who received standard therapy died.

In other words, if you received standard thereapy of saline solution, you were more likely to survive -- or so it seemed.

What's next?

Northfield Laboratories plans to submit a biologic license agreement to the FDA on Oct. 27. If approved, the license would allow Northfield to begin market preparations for use of the product for trauma patients.

Northfield chief executive officer Steven Gould told stockholders that an article about the study is scheduled for publication in the Journal of the American College of Surgeons online as early as November. He said Polyheme's benefits include universal compatibility with all blood types, long-term storage ability and a reduced risk of viral disease.

"I think we've certainly met the endpoints and that this is a product that fills a critically unmet need," Boggust said.

Not everyone believes the product is ready for primetime, though.

Dr. Gregory Vercellotti, professor of medicine in the division of hematology, oncology and transplantation at the University of Minnesota, said he has watched the field of blood substitutes closely -- and he would not use Polyheme.

Vercellotti cites a 2008 Journal of the American Medical Association study that he says looked at all blood-substitute studies, including Polyheme studies, and found increased risk of death and heart attack among patients.

Vercellotti said he believes an oxygen-carrying blood substitute is needed, but he doesn't think Polyheme is necessarily it.

"The real question is does it save lives? And does it save morbidity? Which is another question beyond safety, and I'm just not sure I have seen that," he said.