Trauma patients soon may have a greater chance of survival because of an experimental blood substitute developed in Evanston that now is in clinical trials around the country.
The blood substitute PolyHeme, created by Northfield Laboratories Inc., 1560 Sherman Ave., can be used in situations of urgent blood loss, said Dr. Steven Gould, chairman and chief executive officer.
Besides having a longer shelf life than human blood, PolyHeme also is universally compatible with all blood types, Gould said. That means blood could be delivered to trauma patients sooner and with less risk.
“The application of a blood substitute will … represent one of the greatest advances in trauma care in my lifetime,” said Dr. Ernest E. Moore, chief of surgery at Denver Health Medical Center, one of the hospitals where clinical trials have begun.
PolyHeme currently is undergoing the last round of trials before it can be approved by the Food and Drug Administration. Gould said the company hopes to have 20 trauma medical centers participate in the trial and involve 720 patients.
Dr. Gerard Fulda, director of surgical critical care and principal investigator for the trial at Delaware’s Christiana Hospital, said doctors began to test PolyHeme at his center this month.
Denver Health Medical Center also received permission to begin enrolling patients in the trial earlier this month, said Moore, who is also vice chairman of surgery at the University of Colorado Health Services Center. Moore said the criteria for patients include losing a significant amount of blood and having an acute injury.
Northfield and participating hospitals received federal waivers of consent for the trials, which Gould said is “very unusual.” The waiver allows doctors to decide whether to use PolyHeme in a trauma setting where patients might not be able to give consent.
“It’s a highly volatile subject (of discussion) throughout the United States,” Moore said, adding that without a waiver of consent, the PolyHeme trials could not be conducted.
To inform the public about the study, Moore said his hospital held press conferences and meetings to obtain community consent for PolyHeme in the Denver area. Moore said the public reaction was positive.
Neither Northfield nor the hospitals could comment on the number of patients who already have received PolyHeme.
Gould said Northfield also recently started a “landmark trial” in which the company is looking at the safety and efficacy of using a blood-substitute product at trauma sites and in ambulances, the first time a trial like that has been done in the United States.
Natural blood is not carried in ambulances because by the time a patient’s blood type is determined, the vehicle should have arrived at the hospital. But PolyHeme’s universal compatibility with all blood types means it could be administered immediately.
Another group possibly interested in PolyHeme or a hemoglobin substitute is the military, said Dr. Michael West, chief of the division of trauma and critical care at Northwestern Memorial Hospital and a professor at Feinberg School of Medicine. If there was a medic in the field and someone was injured, PolyHeme could make an essential difference, West said.
Other blood-substitute products have been developed and tested, but Gould said there currently is no FDA-approved blood-substitute product. Fulda said each substitute builds on the previous product.
“Each evolution of the blood products and blood substitutes improves on prior processes,” Fulda said. “This is the next generation of blood processes.”
“If the trial has a successful outcome … the significance is enormous,” Gould said.
