University, LDS Hospitals begin Polyheme trial: Synthetic blood product to be tested as part of nationwide study
January 12, 2006
University Hospital and LDS Hospital, as well as 18 other trauma centers across the United States, are currently enrolling patients in a clinical trial to test a new blood replacement product, Polyheme, in trauma patients.
Polyheme is a “synthetic oxygen-carrying component, which is universally compatible, made of human hemoglobin,” said Lisa Reynolds, study coordinator at University Hospital.
Administering Polyheme will replace the current method of treating trauma patients, which consists of giving patients saline fluids at the site of the trauma and then giving them compatible blood after their arrival at the hospital.
Trauma patients who participate in the study must be 18 years or older, have a blood pressure of less than 90 and have blunt force or penetrating trauma, Reynolds said.
It has taken University Hospital and LDS Hospital over a year to get the proper approval from the U.S. Food and Drug Administration, but the study could be extremely beneficial if the treatment proves to be successful, Reynolds said.
“The potential use in the battle field is incredible; it allows patients who are bleeding to death to continue more efficient treatment until they can get to a hospital,”
Reynolds said.
“The study could have far reaching implications,” said Jolene Fox, study coordinator for LDS Hospital. “Polyheme gives a time frame from injury to arrival where patients are less likely to have oxygen deprivation in their organs.”
The study will include 720 trauma patients nationwide. Approximately 580 patients have participated thus far.
University Hospital and LDS Hospital are two of the last trauma centers to be added to the national study in December. In December, emergency technicians in Utah began using the Polyheme technique for the first time on those who qualify.
Patients are excluded from the study if survival is not likely, or if they received CPR or more than 1,000 CCs of fluid.
People who have a known objection to blood transfusions and pregnant women will also be excluded from the study. The study will continue until the goal of testing 720 patients is reached, which will most likely be within the next six months, Reynolds said.
“We are hoping it will save lives and decrease the high risk organ failure after trauma,” Fox said.