Ore. Researchers Suspend Blood Test Plan
Posted on: Friday, 23 December 2005, 21:00 CST
PORTLAND, Ore. - Portland researchers have suspended their plans to test a blood substitute on unconscious patients, after two years of trying unsuccessfully to get local approval for the experiment.
Researchers with Legacy Health System and Oregon Health & Science University had hoped to make Portland one of the couple dozen U.S. sites testing PolyHeme. That product, made of hemoglobin processed from expired blood donations, is designed to be given to trauma victims instead of saline solution or blood.
Doctors have embraced the idea of a blood substitute, saying it has a long shelf life, can be given to any patient and may carry less risk of inflammation than blood itself.
But the PolyHeme trial faced one big hurdle: The product would be tested on people who were unconscious and could not agree to take part.
A rarely tapped 1996 federal regulation, though, allows trials of possibly life-saving treatments to move ahead without individual consent if planners tell the community about the trial and gauge their feelings.
As of March, both Legacy's and OHSU's research review boards had tentatively approved the project. The researchers then launched a Web site and held a series of meetings to tell the public about the trial and get feedback.
But the meetings were not well-attended - perhaps 75 people were at four of them. After several months, only 31 comments were received, according to hospital spokespeople.
Meanwhile, Multnomah County's research review board has not opposed the trial but has said it still has questions about the plans.
Dr. Dean Gubler, the Legacy trauma expert leading the local effort, said the trial is already far along in other cities, and Portland could not have joined in time to be of much help.
PolyHeme's manufacturer, Illinois-based Northfield Laboratories, already has enrolled more than 500 of the 720 patients it needs.
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Information from: The Oregonian, http://www.oregonlive.com
Source: Associated Press/AP Online
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