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Ed Yeates ReportingA state review board has given the green light to continue testing a new synthetic blood product on severely injured trauma patients. The Board's vote today could have killed the study, effectively ending Utah's participation in the study.
In what appeared to be a done deal last December, University of Utah and LDS Hospitals announced they would join paramedics and EMT's in testing a new synthetic blood product called Polyheme.
Two Utah hospitals were among 31 nationwide participating in a clinical trial where Polyheme would be given as an alternative to severely injured trauma patients. Paramedics would give it at the scene with the hospitals following up in ER's. The synthetic product is designed to stabilize patients and keep them alive, even though their blood loss is substantial.
John Hurdle, University Hospital Institutional Review Board Chairman: "The choice is you can give them water with salt in it, just to maintain how much stuff is flowing through your veins, or you can give them Polyheme."
But reports surfaced that the manufacturer may have withheld information about an earlier study where ten patients getting the product had heart attacks. The University of Utah Institutional Review Board said there was not enough evidence to stop the study. But LDS Hospital did, putting its participation on hold.
Dr. Anthony Musci, LDS Hospital Institutional Review Board Chairman: "The older data that was generated from a prior Polyheme study included some adverse events raised some questions about what the risks really are."
It was expected the State IRB, which oversees paramedics and EMT's, would pull out as well. But today it sided with the University, saying trials should continue.
"The benefit to society is enormous and the risk to participants is in our mind as minimal as it could be made in such a study."
So, Polyheme will be administered on site to selected trauma one victims, but instead of going to LDS Hospital, paramedics will take them to the University of Utah's E.R. Those NOT wanting to participate in the study will wear a bracelet or have one hanging in their vehicle.
