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Leavenworth County, Kan.M Approves Testing Synthetic Blood

Posted on: Tuesday, 28 February 2006, 12:01 CST

By Brad Cooper, The Kansas City Star, Mo.

Feb. 28--Leavenworth County will proceed with testing synthetic blood after receiving assurances from University of Kansas Medical Center officials that the product is safe.

KU officials were asked to appear before the County Commission on Monday after a newspaper report raised questions about the safety of the artificial blood product PolyHeme.

"We need to assure the public (that) we as a commission are looking into it and continuing to ask questions," said Commissioner Dean Oroke.

The medical center has stocked ambulances in Wyandotte, Douglas and Leavenworth counties with PolyHeme to be used in limited circumstances on trauma patients. KU is one of 32 trauma centers throughout the country participating in the study.

"The bottom line is that I think it's safe," said Michael Moncure, the principal investigator for the study and the surgeon in charge of KU's trauma services.

The study has drawn some criticism nationally because investigators have permission to treat trauma patients who may be unconscious and unable to give their consent. But if they choose, residents can get a wristband from KU saying they want to opt out of the artificial blood study.

So far, no one locally has been treated with the artificial blood. Medical center officials predict that only 20 persons will get the transfusion of artificial blood because the eligibility requirements are so narrow.

Moncure said that if the hospital committee that oversees human research had any doubts about the product, the study would be discontinued.

Moncure addressed a Wall Street Journal story about an earlier clinical trial of PolyHeme. In that trial, 10 of 81 patients suffered heart attacks within a week of receiving the substitute blood. Two of those patients died.

The newspaper reported that PolyHeme's manufacturer, Northfield Laboratories of Evanston, Ill., ended the study in 2000 without making the results public.

The company has denied keeping the clinical trial results secret and said the newspaper misinterpreted the earlier study.

Douglas County officials are reviewing the newspaper story and are waiting to hear back from their medical director, who was out of the office Monday.

Moncure said the earlier study was different from the one now under way because it focused on patients undergoing surgery for an abdominal aortic aneurysm. Those patients, he said, were more at risk for a heart attack.

He also said that the patients who received PolyHeme in the earlier study received more fluids than the patients who didn't get the synthetic blood.

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Copyright (c) 2006, The Kansas City Star, Mo.

Distributed by Knight Ridder/Tribune Business News.

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DJ,

Source: The Kansas City Star (Kansas City, Missouri)

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