Article Last Updated: 3/06/2006 02:45 AM
Synthetic blood study delayed
By Jason Bergreen
The Salt Lake Tribune
Two Utah hospitals stopped a clinical study involving the transfusion of synthetic blood in trauma patients after reports surfaced
late last month that the maker of PolyHeme withheld information about an earlier study. Testing was placed on hold Feb. 23 after the Wall Street Journal reported 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 heart attacks, while other patients given real blood did not.
restarted its PolyHeme study Friday. 's remained suspended, pending a decision by its institutional
review board, said Mark Stevens, chief of trauma services. The trial began in December, but no one has received PolyHeme yet.
Stephen Morris, 's trauma director and principal investigator for the trial, said he is satisfied with Evanston, Ill.-based Northfield Laboratories' conclusion "that there are no specific cardiovascular or other adverse outcomes that would jeopardize the safety
of the [current] study."
halted the 2000 PolyHeme study and hasn't published the full results, but Northfield Chairman Steven Gould said PolyHeme didn't
cause the 10 heart attacks or disproportionately more deaths. He said the study was stopped not for safety concerns, but because enrollment was declining and the company wanted to focus on trauma research. The Journal report only fueled debate about the study, which
medical ethicists argue never should have begun in the first place because patients who may receive the experimental substitute might not be able to give their consent.
In the current study, trauma victims may get PolyHeme or saline fluid on the way to the hospital. Once there, PolyHeme treatment might
continue for up to 12 hours, while those on saline would get blood transfusions.
Thirty-one trauma centers in 18 states are enrolled in the study, and preliminary results are expected later this year. Of the 720 patients expected to participate, up to 36 will be from .
Nancy M.P. King, a ethicist who co-authored articles for an ethics journal, is critical of the trial. She
and colleagues wrote that real blood shouldn't be withheld from people who need it without their consent.
''There is a serious ethical flaw in this complicated and novel study,'' says an article to appear this week on the Web site of the American Journal of Bioethics. The ethicists say the problem with the study is when the patients arrive at the hospital. Testing PolyHeme against blood should be done separately in patients who can give consent or who have family members who can consent, wrote King, along with of ethicist Ken Kipnis and anesthesiologist Robert Nelson. The trauma study was approved under a federal ''informed consent'' exemption that applies to emergency research. It requires community briefings in which residents can opt out - in this case by
getting plastic hospital-style bracelets in case they are injured and unconscious. So far, 395 bracelets have been issued to people who don't want to be part of the study, said spokesman Chris Nelson.
Of those, 195 were requested by individuals and 200 were part of a courtesy distribution to Seventh-day Adventist, Christian Scientists, Jehovah's Witnesses and similar churches and organizations that may object to the treatment. But King says community briefings have not made it clear that patients could get experimental treatment and not blood transfusions for several hours even while in the hospital. Many briefings also did not mention the previous PolyHeme study, and withholding that information was wrong, the ethicists said.
Three public hearings were held last June in City, West Valley City and , 's Morris said.Data from more than half a dozen PolyHeme studies were discussed during the meetings. Morris said he was aware of the heart attacks in the earlier study before the recent testing was approved by the 's institutional review board. At the public hearings, "we did discuss that there were adverse outcomes in the previous study," he said. However, because the heart attacks in the 2000 study could not be linked PolyHeme, specifics about the trial were not directly addressed, Morris said. "If there is no causal relationship it is hard to talk about cause and effect," he said. "There is no specific evidence that the heart attacks were connected to the [2000] study. . . . It appears it was very
unclear what the cause could be."
The institutional review board approved the new study because it involved trauma patients instead of heart surgery
patients, Morris said. To be eligible for the study, patients must be 18 years old. Research would exclude pregnant women, children, the elderly and patients known to object to blood transfusions. Several times during the study's postponement, Morris spoke to representatives of and an independent data monitoring committee that was reviewing the current PolyHeme study. Of the 500 out-of-state patients already involved in the trial, it was determined there was no significant difference in the outcomes of patients given PolyHeme and those
given real blood, he said.
The Associated Press contributed to this report. Synthetic blood study PolyHeme is a blood substitute, compatible with all blood types, that can be given to trauma victims immediately. Up to 36 Utahns are to be included in a clinical study, but half will receive the current emergency treatment, such as saline solution. Because the patients may not be able to give consent, anyone who wants to be excluded can wear a bracelet provided by the hospitals.
Call Lisa Reynolds at 801-585-0385 to obtain a bracelet.