Ky. Hospital to Use Blood Substitute
By MURRAY EVANS Associated Press Writer
LEXINGTON, Ky. (AP) - Severely injured patients treated at the University of Kentucky Hospital trauma center could soon begin receiving a blood substitute as part of their care.
UK Hospital is one of seven trauma centers that are launching a national clinical trial to evaluate the oxygen-carrying blood substitute called PolyHeme, which is manufactured by Northfield Laboratories of Evanston, Ill. The trial, which will begin at UK Hospital in early May, will evaluate the safety and efficacy of PolyHeme in the treatment of severely injured trauma patients.
"There have been hemoglobin-based oxygen carriers and other oxygen carrier solutions in development for decades," said Andrew Bernard, a trauma surgeon at UK Hospital. "We are currently as close as we have ever been to having one of these products market-available for use."
The study will be conducted under a federal regulation that allows research to be conducted in certain life-threatening situations using an exception from the requirement for informed consent. That regulation requires community consultation before the study begins. Bernard said 19 community meetings were held to discuss the trial.
Of the 593 people who attended at least one of the meetings and completed a survey, Bernard said 92 percent would allow the product to be used on them, if necessary.
The Food and Drug Administration has approved about 15 of the no-consent studies since the exception was added in 1996. This will be the first time UK Hospital has been involved in such a study, Bernard said. Northfield Laboratories has proposed enrolling 720 patients in the study, of which 40 to 50 will come from UK Hospital.
Eventually, 20 hospitals will be involved in the study, Bernard said. The other six facilities are in Colorado, Texas, Ohio, Pennsylvania, Delaware and Tennessee.
Patients from three Kentucky counties - Scott, Woodford and Jessamine - are eligible to participate in the study, although Bernard said more counties, including Fayette, might soon be included.
Under current care standards, trauma patients receive saline solution for hydration in the field, and then their blood is typed and matched for transfusion at the hospital. Trauma patients who have lost large amounts of blood display dangerously low blood pressure and are at risk of organ failure and death due to oxygen deprivation. PolyHeme's oxygen-carrying properties should help in that regard, Bernard said.
In the study, patients meeting the eligibility criteria - at least 18 years old and with a systolic blood pressure of 90 or less - will be assigned randomly to receive infusions of either saline solution or PolyHeme while en route to the hospital, either by ambulance or medical helicopter.
Once at the hospital, those patients on PolyHeme will receive saline for hydration and up to six units of PolyHeme during the first 12 hours. After that, blood transfusions will be used.
PolyHeme is made by extracting oxygen-carrying hemoglobin from human red blood cells. It can be given to people of any blood type and doesn't negatively affect the immune system like a blood transfusion sometimes can, Bernard said.
It also can be carried in ambulances and medical helicopters, unlike blood, which has a short shelf life.
Ernest Moore, chief of trauma surgery at Denver +Health+ Medical Center, one of the other hospitals involved in the study, has said the blood substitute could revolutionize how doctors resuscitate patients.
Duane Lee, the director of Georgetown-Scott County Emergency Medical Services, said it makes sense to include emergency medical service providers in the study. EMS workers in the three counties will receive training in determining when to use PolyHeme.
"We've been part of the +health+ care field forever," Lee said. "A lot of times, we're not thought of as part of the +health+ care field, but we are. To advance medicine in a pre-hospital environment, you have to get us involved."
The study will take a year, Bernard said. It likely would be at least 2 1/2 years before the product might be available on the open market, he said.
Patients can opt out of the study before treatment by obtaining a bracelet, similar to a medical alert bracelet, from study coordinators. Patients already in the study can opt out at any time, Bernard said.
2004-04-22 11:16:14 GMT