By Matthew Roy
The Virginian-Pilot
Copyright 2007 Landmark Communications, Inc.
NORFOLK, Va. — A blood substitute product given to seriously injured patients here in a clinical trial did not demonstrate an advantage over the standard treatment, the chief local researcher said.
Dr. Leonard J. Weireter Jr., medical director of the Shock Trauma Center of Sentara Norfolk General Hospital, led the local research involving PolyHeme, a product made from hemoglobin and tested on trauma victims.
PolyHeme was tested at more than 30 sites around the country. Locally, Eastern Virginia Medical School, where Weireter is a professor; Sentara; and Norfolk Fire-Rescue participated.
Paramedics administered PolyHeme to some patients who suffered major blood loss. Others in a control group got the standard care: a saline solution followed by blood transfusions at the hospital.
The local trial was approved in 2004 and ended more than a year ago. The findings were reported in October to the American College of Surgeons Annual Clinical Congress, Weireter said. “Now that the company’s presented it, it’s open for talking about,” he said last week.
Weireter said there was no “significant difference” in survival for those treated with PolyHeme versus a control group. “The study was intended to demonstrate a survival advantage, and it failed to do so,” he said.
PolyHeme was developed by Northfield Laboratories of Evanston, Ill. The company has been seeking U.S. Food and Drug Administration approval for its product.
The study was permitted under a controversial exception from rules that require advance consent in medical research. The exception can apply when the subjects face life-threatening situations, available treatments are unsatisfactory and obtaining consent is not feasible.
The study involved a total of 714 people nationwide. Northfield reported that 13 percent of the people treated with PolyHeme died, compared with 10 percent of a control group. After excluding cases that did not fit the study protocol, 11 percent of those treated with PolyHeme died, versus 9 percent in the control group, Northfield said.
Locally, 34 patients were enrolled in the study. Eighteen in a control group got saline; two of them died. Of the 16 who got PolyHeme, two died.
“They were both people who we would have expected to die,” Weireter said. “Both those were terribly injured patients. One was in essence dead on arrival here. The other one ... died in the operating room, some while later, of multiple gunshots.”
Weireter said researchers are somewhat disappointed and perhaps surprised that PolyHeme didn’t fare better. “But you have to realize, that’s the nature of doing science.”
Northfield shares, which had traded for more than $13 in December 2005, closed at $1.10 a share on the Nasdaq on Wednesday.