In Utah, it's a clinical trial where no product's been tried. Locally, the blood substitute called PolyHeme has yielded no clinical information, but lots of debate.

Since Utah's two trauma-one centers and a group of emergency crews announced joint participation in the study in December, no Utah patients have received the hemoglobin-based blood substitute. And the hospitals have bobbled in and out of participation. Meanwhile, nationally, the study is nearly complete.

LDS Hospital's Institutional Review Board this week gave its blessing to reinstatement of the study of PolyHeme, a hemoglobin-based blood substitute which would be administered to trauma patients who suffered heavy blood loss right at the scene of their injury. Normally, such patients are given saline and are transported to area hospitals.

In the study, patients who meet clear-cut criteria are to be randomized to receive the PolyHeme immediately and for up to 12 hours after arriving at a hospital, or saline, followed by blood administered on arrival at the hospital. The advantage of the blood substitute, experts say, is it carries oxygen to organs, which saline does not.

Meanwhile, University Hospital has its participation on administrative hold, which may or may not end soon. And although LDS Hospital's board approved continuing the study, the Division of Trauma Services, which is running the study there, has kept it on hold until it sees what the U. plans to do.

"The reason is, it's a joint study and from a logistics and practical standpoint, it does not make sense to have only one trauma center participating," says LDS Hospital spokesman Jess Gomez.

The holds do not indicate concerns about the value of the study, experts at both hospitals say. They agree the study is important and that a product that works as a suitable substitute for blood, and which doesn't have to be cross-matched, could save lives. The trial is designed to see if PolyHeme is such a product.

Both hospitals halted participation, effectively closing the study down in Utah, in early March right after a Wall Street Journal article called into question whether PolyHeme manufacturer Northfield Laboratories had hidden a possible link between the synthetic blood product and some heart attacks. Shortly after, in early March, the U. decided that wasn't the case and rejoined the study after the state Department of Health IRB agreed to continue a waiver it had granted that allowed "community consent" to participate unless someone specifically took steps to opt out of the study.

Consent has been a big issue for this study, because it's likely many of the potential participants would be unable to give "informed consent" to take part. Instead, they are covered under a kind of broad-based communitywide consent, and steps were taken to allow people to indicate with a pink bracelet on their rearview mirror or in other ways that they do not want to be included should they suffer a traumatic injury.

LDS Hospital held off until last Thursday. It had requested some information from the manufacturer and after reviewing that, decided it was satisfied with the responses to its questions, Gomez said.

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The U. IRB put the study on hold again April 6 after a routine annual review, in order to sort out some administrative details, says Christopher Nelson, U. Hospital spokesman. Now the hospital is in the process of deciding whether to jump back in. The decision will likely be the final word on the fate of Utah's portion of the study, which was originally expected to include about 36 Utah trauma patients out of 720 nationwide.

But time is not on their side for completing the study, says Dr. Stephen Morris, trauma director at the U. Nationally, only about 70 more participants are needed to complete the study, which has more than 30 centers participating. If a decision isn't made soon, it won't matter.

Four months into Utah participation, no one locally has been given PolyHeme. Fewer than a handful of participants have been placed in the trial at all and, by random draw, all have been assigned saline, which is the standard treatment anyway.


E-mail: lois@desnews.com

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