Blood-substitute study goes nowhere in Utah

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.