U. rejoins study on substitute for blood

A clinical study of a blood substitute has a state health panel's blessing to proceed. But the two Utah trauma centers that signed on for the study are split in their decisions on whether to continue with the 31-center national trial.

University Hospital is going ahead; LDS Hospital has put its participation on hold until some questions are answered, said LDS Hospital's Dr. Anthony Musci.

The Institutional Review Board of the Utah Department of Health voted on Friday to continue a "community waiver" that allows the clinical trial of PolyHeme, a blood substitute that is compatible with all blood types and can be given to trauma patients before they ever reach a hospital. The study is designed to test whether the hemoglobin-based, oxygen-carrying blood substitute increases survival for critically injured patients who would otherwise be given saline until they could receive blood.

To participate, a person must be at least 18, not obviously pregnant and have clear signs of traumatic blood loss, including being in shock and falling blood pressure. Those patients might not be in a condition to have the study risks or potential benefits explained, so the waiver was needed to provide permission. Under the waiver, unless someone excludes himself from the study — there's a pink bracelet that can be hung on the rearview mirror or worn and people who can speak can simply say no — those who meet the criteria will be randomly selected for the study.

Both hospitals stopped the study after an article in the Wall Street Journal reported that Northfield Laboratories, which makes PolyHeme, had hidden a possible link between the synthetic blood product and 20 heart attacks. The U. rejoined the study earlier this month.

No one in Utah has yet received PolyHeme as part of the clinical study, health officials were told. The study began in Utah in December, and a target 36 participants were to be randomly selected to receive saline or PolyHeme.

During the state IRB meeting, representatives from both LDS and University hospitals said they believed the information on the heart attacks had, in fact, been included in the material provided as preparation for the study. Further, it was noted that more than 500 of the target 720 subjects nationally had already participated, with no new evidence of any link to heart attack.