County reviews blood substitute trial

PolyHeme maker shut down earlier test, report says

Douglas County ambulance officials will meet today to review their participation in clinical trials for PolyHeme, an experimental blood substitute being tested on trauma patients.

The meeting comes in the wake of a Feb. 22 Wall Street Journal report that Northfield Laboratories Inc., the Evanston, Ill.-based maker of PolyHeme, shut down an earlier trial after 10 of 81 patients who received the synthetic blood suffered heart attacks. Two of those patients died, the newspaper said.

“We will be visiting with our medical director, hopefully tomorrow, about the Wall Street Journal article and Northfield Labs’ explanation,” Jim Murray, a division chief for Lawrence-Douglas County Fire & Medical, said Tuesday.

But a spokesman for Kansas University Medical Center, which is overseeing local tests of the blood substitute, said Tuesday the study was being conducted under strict oversight – and that KU officials had disclosed the earlier study during public education sessions leading to the start of the trial.

Reviews of the newest trial have shown “no health trend that would stop or delay the study,” said Dennis McCulloch, a spokesman for the Med Center.

Northfield Laboratories did not return a call for comment; neither did a spokesman for the federal Food and Drug Administration, which grants permission for such tests.

PolyHeme has been in Douglas County ambulances – five in Lawrence, one in Baldwin – since early January, and also is being tested in Leavenworth and Wyandotte counties.

The fluid is intended to replace the saline solution that emergency responders use to quickly replace blood lost by trauma victims during emergencies. Carrying blood in ambulances is too difficult because it has a relatively short shelf life. PolyHeme can last up to one year. PolyHeme also can be universally distributed, while blood must go only to matching blood types.

Only one patient in the Kansas test area has received PolyHeme so far, McCulloch said.

“It’s a slow process,” he said of testing.

McCulloch said subjects in the earlier, aborted test received a PolyHeme-saline mix, with as much as 20 units of PolyHeme pumped into patients. The current trial, he said, limits PolyHeme use to six units.

“What we’re dealing with in the (new) study itself is an apples-and-oranges situation” compared to the earlier trial, McCulloch said.

Leavenworth County commissioners on Monday decided to continue with their participation in the project after meeting with KU officials and the county’s ambulance director.

“All the questions were answered,” Commissioner Donald Davinsky told the Journal-World. “We feel there hasn’t been anything explained to us to suspend the potential use of it.”

McCulloch said 41 “opt-out” wristbands had been distributed to area residents who don’t want to receive PolyHeme in case of emergency. To obtain a wristband, contact study coordinator Suzanne Porras at (913) 588-3005 or sporras@kumc.edu.

PolyHeme trial excludes some patients

The Kansas University Medical Center is participating in a national clinical trial to evaluate the safety and efficacy of PolyHeme, a temporary oxygen-carrying red blood cell substitute, in treating critically injured and bleeding patients. Emergency responders in Douglas, Wyandotte and Leavenworth counties are assisting with the study.
Patients who are eligible for the study include those:
¢ who have lost a large amount of blood and are in shock.
¢ who are at least 18 years old.
¢ who have sustained severe injuries.
Patients who will be excluded include those:
¢ who are obviously pregnant.
¢ who are known to object to blood transfusions.
¢ who are known to refuse resuscitation.
For more information, see www.kumc.edu/polyheme.