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Blood substitute trials: So far, none of the 36 doses reserved for Utah has been used on patients
By JASON BERGREEN
The Salt Lake Tribune (Utah)
The Utah Department of Health decided Friday that a clinical study involving the transfusion of an experimental blood substitute in trauma patients is safe and ethical, despite mixed conclusions by two local hospitals participating in the trial.
The department could have restricted participating emergency first-responders from injecting patients with PolyHeme, but instead voted 6-to-1 to defer to University Hospital’s decision to proceed with the study.
Board member Laurie Baksh abstained, saying she wanted to hear more from LDS Hospital, which has postponed its study citing scientific and ethical considerations.
Testing was placed on hold late last month at both hospitals after the Wall Street Journal reported the maker of PolyHeme, Northfield Laboratories, tried to hide crucial details about a 2000 blood-substitute study. The Journal reported that 10 heart surgery patients in that experiment had experienced heart attacks, while other patients given actual blood did not.
The Department of Health board contends that details from the 2000 study were disclosed to the hospitals. Stephen Morris, University Hospital’s trauma director and principal investigator for the trial, said he received the information before the current study began.
The board also agreed that the study’s consent form adequately informed potential patients about the study’s enrollment procedure and outlined who could participate in the study.
But concerns were raised about how first-responders would determine whether an unconscious female trauma patient were pregnant. Children, “obviously pregnant” women, patients with severe head injuries, those who have known objections to blood transfusions and those who have special bracelets indicating they don’t want to participate are exempt from the study.
LDS Hospital representative Matt Rydman said his hospital review board opted out of the study Thursday because it wants more information about the results of the 2000 study. He said the board didn’t think the public was sufficiently informed about the heart attack victims in the 2000 study. The board also requested that information pertaining to the possibility of fluid overload in the body when PolyHeme is introduced be stated clearly on the consent form.
Morris said University Hospital restarted its study March 3 after receiving assurances from Northfield and an independent committee that the current study did not pose cardiovascular or other adverse risks that would jeopardize the safety of the trial.
Emergency medical service agencies from Salt Lake and West Valley cities, Sandy and Summit County are participating in the study, though PolyHeme has not yet been given to any patients from Utah.
PolyHeme is a blood substitute, compatible with all blood types, that can be given to trauma victims immediately. Thirty-one trauma centers in 18 states are enrolled in the study. Of the 720 patients expected to participate, as many as 36 will be from Utah.