Durham Emergency Medical Services personnel won't be able to start testing a new blood substitute for critically injured trauma patients until Duke University Health System officials resolve questions about the legality of the clinical trial.
It's the second significant delay for researchers at Duke University Hospital, who originally announced plans to start testing the blood substitute, PolyHeme, last summer.
The study first was delayed until Jan. 1 to hold four public hearings for community members to comment on the clinical study. Normally, new medicines are tested on people who consent to being "guinea pigs." But the people who would get PolyHeme would be in shock and unable to make rational, legally binding decisions. So a 1996 federal law allows communities to give blanket approval for such testing after explaining the testing process.
Duke's proposed test cleared the federal regulatory hurdles, only to run into PolyHeme shipment delays, said Tracey Koepke, spokeswoman for the Duke University Health System.
Then came the glitch with state rules. Jeff Horton, chief of licensing with the state Department of Health and Human Services' Division of Facilities Services, said Tuesday that he called Duke last month to tell researchers state rules aren't as flexible as federal laws about so-called "implied consent."
Horton said the 17-member N.C. Medical Care Commission, appointed by the governor to implement hospital standards, adopted the state rules for hospitals in 1996 -- just 10 months before the federal guidelines took effect. He said the commission could consider a rule change to coincide with the federal law as soon as next month, though that could still require many more weeks to go into effect.
The research on patients headed for Duke's emergency room is part of a study at 16 major trauma centers throughout the United States, evaluating the safety and effectiveness of the blood-derived product as an oxygen-carrying blood substitute in trauma patients. Adult trauma victims suffering massive blood loss would be randomly selected to get either PolyHeme or traditional saline solution as part of their life support treatment. Later, scientists are to compare the patients' outcomes.
Most ambulances don't carry blood because it's difficult to store and match with the victim's blood type. Instead, emergency medical crews give intravenous saline solution -- salt water -- to compensate for lost blood volume and the resulting, dangerous drop in blood pressure. But saline doesn't carry oxygen to keep organs alive. Physicians believe PolyHeme can deliver oxygen to patients without risk of disease transmission. It also has a shelf life of 12 months, versus the 42-day shelf life of whole blood.
Northfield Laboratories Inc., a suburban Chicago biotechnology company, makes PolyHeme.
