A hemoglobin-based blood substitute that was tested in Utah may increase the chance of survival for trauma patients who do not have ready access to blood, according to the long-awaited results of a multistate clinical trial.
Both University and LDS hospitals and area ambulance services participated in the study of PolyHeme. Under a community waiver, unless someone had displayed a not-me bracelet or otherwise indicated they didn't want the substance, patients at risk of dying from trauma and blood loss could be randomized to receive either it at the scene or the standard care, including administration of fluids until the patient could be given blood at the hospital.
The study did not show a difference between the outcomes of the two treatment approaches, said Dr. Stephen Morris, chief of trauma at University Hospital. "It did not show any harm, and that is probably the most important thing. As a modality, we know blood can be lifesaving, and when it's not available, this could be a surrogate, such as in rural trauma or in prehospital situations."
A viable blood substitute is of particular interest in rural areas, he noted, since most people in urban areas can get to the hospital and be given blood quickly.
Morris said he would always choose to give blood, if it were available quickly. But trauma experts are always looking for tools to help, especially during the crucial "golden hour" following a trauma, a period that can significantly influence survival.
In the study of 714 patients, 82 who received PolyHeme died, compared to 36 of 365 patients who had standard treatment. That difference in deaths (13 percent vs. 10 percent) "fell outside the boundary to meet the primary efficacy endpoint agreed upon with the FDA," according to the release explaining the study. "However, the difference in the number of deaths was not statistically significant, meaning the outcomes were similar regardless of the treatment the patient received."
Three Utahns were enrolled in the study, but none of them received PolyHeme. They all survived their traumas.
The study was at times controversial and both LDS and the U. put participation on hold temporarily, after questions were raised about whether the substance was linked to increased heart attacks.PolyHeme is made by Illinois-based Northfield Labs.