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Archive for Thursday, August 4, 2005

Synthetic blood treatment may soon be available

August 4, 2005

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Critically injured trauma patients in Douglas County may soon be eligible for a new type of treatment - synthetic blood.

Officials with Lawrence-Douglas County Fire & Medical are meeting to decide whether to pursue allowing the use of PolyHeme, a blood-like substitute that has been promising in saving lives during early clinical trials.

The Kansas University Medical Center is launching a new trial and is seeking area counties to participate.

"We haven't yet decided whether we'll be participating or not," said Mark Bradford, deputy chief of Lawrence-Douglas County Fire & Medical.

Several area counties - including Wyandotte, Johnson and Leavenworth - have shown interest in the trial, KU officials said. Franklin and Miami counties also might participate.

Currently, EMTs at an accident site are only allowed to give trauma patients who are severely bleeding a saline solution, which can't carry oxygen to the body. Blood transfusions are impractical in the field, in part, because of difficulty matching blood types and the availability of blood.

PolyHeme, which is manufactured by Northfield Laboratories in Evanston, Ill., can be given instead. The fluid allows for oxygen transport in severely wounded patients, increasing their chances for survival.

"I think it's going to make a big difference from the standpoint of being able to administer something that's safe," said Michael Moncure, the KU doctor who is overseeing the study. "We don't have to worry about a reaction or patients that don't want blood transfusions."

The Food and Drug Administration generally requires individuals to consent before subjecting them to clinical trials.

But since trauma patients generally can't give that consent, the FDA has allowed a rare exception. Instead, KU will seek community support for the project in the counties pursuing participation in the trial, including meetings with EMS personnel, government leaders and the public.

Opt-out bracelets will be given to anyone who wouldn't want to be treated with PolyHeme.

In counties that do give support for the trial, responding personnel will give PolyHeme to half the major trauma patients they treat, with the rest receiving the usual saline solution.

The study results will be combined with results from about 20 other hospitals across the country. The FDA is expected to decide in six months to a year whether to approve use of PolyHeme beyond the trials, Moncure said.

In Douglas County, only patients headed to the University of Kansas Hospital would be eligible to receive PolyHeme. Those include those transported by ground ambulance and air ambulance.

Patients headed to Lawrence Memorial Hospital wouldn't be eligible, Moncure said. He said the project wouldn't lead to a loss of patients at LMH.

If Lawrence-Douglas County Fire & Medical personnel decide to pursue the trial, KU would conduct community meetings in the next six to eight weeks to inform the public.

Moncure said he hoped Douglas County gave the project the green light.

"I think it's a tremendous opportunity," he said. "It's probably one of the most exciting studies around the country, particularly in trauma."

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