SAN ANTONIO, Texas — A national two-year study of an experimental blood substitute in critically injured patients, including 19 in San Antonio, found that those transfused with the artificial blood were more likely to die, and more likely to suffer a nonfatal heart attack, than those who received saline solution instead, local doctors said Wednesday.
And while those results show the blood substitute known as PolyHeme probably has little value in an urban area like San Antonio where real blood is available within minutes, a military surgeon involved in the study said it still could be useful treating badly wounded soldiers in remote places, hours — or even days — from the nearest hospital.
Unlike saline, PolyHeme can carry life-sustaining oxygen from lungs to the rest of the body.
The study was controversial, in part because subjects in most cases were too badly injured to give consent. Federal health officials allowed the study to go forward if participating hospitals held community meetings to explain the study and its risks.
Fourteen such meetings were held in San Antonio and throughout the 22-county region its trauma centers serve.
Two public meetings to discuss the study s findings with the community will be held, the first at 6:30 p.m. Monday at University Family Health Center-North at 302 W. Rector St.; and a second meeting geared toward medical and research professionals at 5 p.m. Nov. 15 at the University of Texas Health Science Center, Room 3.102B. The public also can attend that meeting.
It was put to a good scientific test, and now we know that PolyHeme probably doesn t have utility to be in helicopters and urban ambulances where transport s short and blood s available, said Dr. Ronald Stewart, trauma medical director at University Hospital.
Stewart said the national death rates in the two groups — 13 percent in the PolyHeme group and 10 percent in the saline group — were statistically the same. Of the 14 patients seen at University Hospital and the five at Brooke Army Medical Center, two patients given PolyHeme died, with one death in the saline group.
In San Antonio, patients suffering from hemorrhagic shock after injury and massive blood loss were randomly selected to get either PolyHeme or saline by San Antonio AirLife helicopter ambulance crews at the scene, or in the air en route to one of the two trauma centers. They ranged in age from 15 to 63.
Nationally, 11 patients given PolyHeme suffered nonfatal heart attacks, vs. three given saline. In San Antonio, one patient in each group suffered a heart attack.
Col. Toney Baskin, a staff surgeon with the U.S. Army Institute of Surgical Research, who headed the study at BAMC, said the product could save lives on the battlefield.
My son s an infantryman, and I wouldn t hesitate to give him the product if he was bleeding to death, until he got to where he could get blood, Baskin said, adding that the military would require Food and Drug Administration approval.
Although the results of the study haven t yet been published, the findings were presented at a meeting of the American College of Surgeons last month. That convinced local officials to go ahead and present the findings now.
Northfield Laboratories, which makes PolyHeme and sponsored the study, has been criticized for failing to publish negative results from an early PolyHeme study that showed it raised the risk of heart attack.
The company denies the charge, calling the early study flawed. A Wall Street Journal report last year highlighted educational materials provided by BAMC at a community meeting that stated earlier studies of PolyHeme had shown no adverse effects.
Baskin, who led that community meeting, said he discussed a possible higher risk of heart attack in his presentation.
Stewart offered no apology for the trial, arguing it was the only way to find out whether the product could save lives.
- Over a two-year period, 714 critically injured patients, including 19 in San Antonio, were given either PolyHeme blood substitute or saline.
- University Hospital and Brooke Army Medical Center were among 32 U.S. medical centers participating in the study.