Synthetic Blood Study Delayed in Utah

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.

University Hospital restarted its PolyHeme study Friday. LDS Hospital's remained suspended, pending a decision by its institutional review board, said Mark Stevens, chief of trauma services. The Utah trial began in December, but no one has received PolyHeme yet.

Stephen Morris, University Hospital'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."

Northfield 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 Utah.

Nancy M.P. King, a University of North Carolina 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 University of Hawaii ethicist Ken Kipnis and Philadelphia 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 University Hospital 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 Salt Lake City, West Valley City and Sandy, University Hospital's Morris said.