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Nature Medicine 13, 652 (1 June 2007) | doi:10.1038/nm0607-652;
Emergency trials of blood substitutes skirt ethical questions
Abstract
Did you wear a thick, blue plastic bracelet with the words “I decline the Northfield PolyHeme study” splashed across it in bold black writing during the years 2004 to 2006? If not, and had you been in a serious accident during that time, you could have been unwittingly enrolled in a phase 3 clinical trial for the blood substitute PolyHeme. More than 700 patients at 32 trauma centers in 19 US states were—without consent—given the blood substitute, made from modified hemoglobin, to treat severe blood loss at accident scenes, in ambulances and even in emergency rooms.
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