County OKs continued blood study
Patients could receive synthetic blood during emergency treatment
Leavenworth County commissioners have approved the county's continued participation in a study in which Emergency Medical Service officials may administer synthetic blood to trauma patients.
The decision came last week, after officials with the Kansas University Medical Center and the director of Leavenworth County EMS gave the study their backing.
Patients chosen for the study are randomly selected to receive PolyHeme, a substitute for red blood cells that matches all blood types. Those eligible must be at least 18 years old, suffering from shock, heavy blood loss and severe injuries. Those treated with PolyHeme are not told at the time of their emergency.
The county commission called the meeting as a result of a recent Wall Street Journal article that cited problems in a study sponsored by PolyHeme manufacturer Northfield Laboratories Inc. of Evanston, Ill. According to the article, 10 of 81 patients in a previous study suffered heart attacks within approximately one week after receiving PolyHeme. Two of those patients died. The article also alluded to Northfield failing to make its findings public, a notion that presents a problem considering 32 trauma centers across the nation are participating in a similar study.
Dr. Michael Moncure, director of trauma at University of Kansas Hospital in Kansas City, Kan., is responsible for overseeing the study in this area. He gave his support for its continuation, despite concerns raised in the newspaper.
"I don't think the claim by the Wall Street Journal is correct," Moncure said.
He said the previous study focused on patients with cardiovascular problems. Along with saline solution, the current care standard, they were given PolyHeme. The amount of fluid, he said, was excessive and made patients with cardiovascular disease susceptible to heart attacks.
The current study focuses on trauma patients only, he said.
PolyHeme 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, while PolyHeme can last up to one year. PolyHeme also can be universally distributed, while blood must go only to matching blood types.
Commissioner Clyde Graeber at first expressed concern over the newspaper's report.
"If there is any danger at all in its usage, then it needs to be stopped," Graeber said.
Graeber also mentioned how he found it unreasonable that residents must contact KU to receive a blue wristband that would alert EMS officials they don't want to participate in the study in the event of an emergency. He questioned how realistic it was that locals be made aware of the wristbands.
Moncure said that there had been some advertising and local awareness had been positive.
He defended the use of PolyHeme by presenting the commission with the current standing of the nationwide study.
So far, he said, more than 500 patients have been entered in the study, and doctors have found no problems with regard to heart attacks in accordance with the use of PolyHeme.
Jamie Miller, Leavenworth County EMS director, said he didn't think there was reason to hold off on the study, although he estimated only 20 patients a year would qualify in Leavenworth County.
"I believe it is a good product," Miller said.
The Kansas study is being conducted in Leavenworth, Wyandotte and Douglas counties. Leavenworth EMS teams began carrying PolyHeme in ambulances on Jan. 6.
Only one patient in the Kansas test area has received PolyHeme so far, said Dennis McCullough, director of public relations for the University of Kansas Hospital and Medical Center.
Proceed with study
After hearing Miller and Moncure, commissioners agreed to continue with the study in Leavenworth County.
"I see no reason to discontinue this," commissioner Donald Navinsky said. Graeber and commission chairman Dean Oroke both agreed.
In an interview after the meeting, McCullough said patients who become part of the PolyHeme study actually might save some money on medical costs they incur because of their emergency.
"All of the testing that you would probably have done anyway would be covered because it's necessary for the data collection on the PolyHeme," McCullough said.
He said that the medical center is not paid for its participation in the PolyHeme study -- but some expenses, including staff time and supplies, are covered by Northfield Labs, the study sponsor.
"It is purely a matter of picking up expenses," McCullough said. ''... This is truly an expense reimbursement. It's not a profitable thing. It's not: You'll get $15,000 for participating."