An experimental blood substitute has been delivered to Douglas County ambulances and is ready to be pumped into emergency patients, but a similar trial in California has sparked criticism and legal battles.
"If this really works, this will revolutionize the treatment of patients with hemorrhagic blood loss due to trauma," said Jim Murray, support services division chief with Lawrence-Douglas County Fire & Medical.
PolyHeme has been placed on six area ambulances - five in Lawrence and one in Baldwin. It will be administered to qualifying, critically-injured trauma patients. The blood substitute also will be used in Leavenworth and Wyandotte counties.
PolyHeme, developed by Northfield Laboratories Inc. and used in several study sites across the country, has seen its share of problems and controversy. In California, the weekly San Diego Reader is battling the company over the publishing of details about the project. Northfield representatives say the paper is trying to publish "trade secrets" contained in public documents.
A concern, according to Richard Spirra, the newspaper's attorney, is that PolyHeme is tested on people without their consent.
According to articles printed in the Reader, the newspaper found that the trials in San Diego targeted the neighborhoods of poor and minority residents "unlikely to have heard of the study and unlikelier still to have the resources to sue if something goes awry."
Scott Robinson, an emergency room doctor at Lawrence Memorial Hospital and the medical director for Lawrence-Douglas County Fire & Medical, said similar problems won't occur here.
"Informed consent is such a part of our society that everybody is very sensitive to it," he said.
Is it beneficial?
PolyHeme is a human hemoglobin-based oxygen-carrying substitute.
Emergency responders currently use saline 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 stand up to one year. PolyHeme also can be universally distributed, while blood must only go to matching blood types.
"PolyHeme, so far, has been shown to be very, very safe," Robinson said. "What we don't know yet, without doing these studies, is: 'Is it beneficial?'"
The local portion of the Food and Drug Administration trial is being spearheaded by researchers with KU Medical Center.
Organizers of the PolyHeme trial say that because it is aimed at trauma patients in the worst emergencies, informed consent isn't possible. The trial has received a special waiver, allowing Northfield and local organizers to conduct a public-information campaign and offer opt-out bracelets for potential patients to wear.
To date, Douglas County residents have asked for 31 out of 75 bracelets distributed. During an emergency, a patient or the patient's family also can request to opt out.
Robinson said PolyHeme use wouldn't be limited to poor and minority residents, as alleged in California.
"We don't treat people based on where they live or what their ability to pay is," he said. "We treat people based on what their medical needs are."
Michael Moncure, a KU doctor serving as the principal local investigator, said the trial has had to go through a rigorous process with the FDA. If it's found that patients who receive the substitute do worse than they would with the standard treatment, he said, the study would be stopped.
A spokesperson for Northfield Laboratories did not return a phone call Monday. A meeting between Northfield officials and representatives of the San Diego Reader is set for today, Spirra said.