Enrollment ends in blood substitute trauma study
Area residents wearing "opt out" bracelets can remove them
Report on results expected in a few months
(SAN ANTONIO - August 4, 2006) Enrollment of patients in a blood substitute study at several level 1 trauma centers throughout the U.S., including San Antonio's University Hospital and Brooke Army Medical Center, concluded this week. The study, which began in 2004, involved the use of PolyHeme®, an investigational oxygen-carrying blood substitute, developed by Northfield Laboratories Inc.
The Phase III trauma study with PolyHeme is the first trial in the U.S. designed to evaluate the safety and efficacy of an oxygen-carrying red blood cell substitute beginning at the scene of injury and continuing during transport and in the early hospital period. The study had a planned enrollment of 720 patients suffering from hemorrhagic shock due to massive blood loss.
Hemorrhagic shock causes the patient's blood pressure to become dangerously low, often leading to organ failure and death. "This is important research," said Dr. Ronald Stewart, associate professor of surgery at The UT Health Science Center and trauma medical director at University Hospital. "About 30 percent of shock patients who receive the current standard care, intravenous saline solution, die. That is unacceptably high and the only way to find a better standard of care is through this type of research."
In San Antonio, patients enrolled in the study were randomly selected to receive either the PolyHeme or saline solution. Due to the fact that these severely injured patients were unable to give informed consent prior to enrollment, the study was conducted under a provision of a federal regulation (21 CFR 50.24) that allows for an exception from informed consent requirements. However, to utilize this provision, study coordinators were required to carry out a public disclosure and community consultation process.
Certain findings in the new report especially stand out.
For example, in 2005, San Antonio had the smallest percentage of working-age (18-64) patients affected by the disease among Texas' largest metropolitan areas at 60.5 percent. The Alamo City also had the lowest percentage of Type 2 diabetes patients ages 35 and under at 4.9 percent Austin topped the working-age category at 77.5 percent while the state average was 64.7 percent. Meanwhile, the Fort Worth/Arlington market ranked highest in the 35-and-under category at 5.9 percent, while the state average was 5.2 percent.
Terri De La Haya, senior vice president of San Antonio's Texas Diabetes Institute, says there are reasons the Alamo City is making some progress.
"I think San Antonio has taken a more proactive approach," she says. "There has been a lot more collaborative effort than what we used to see."
Red flags
There are some negatives for San Antonio.
Those who have the disease are paying more for treatment here than patients across the rest of the nation are on average.
According to the Business Group on Health report, the average annual inpatient hospital cost per Type 2 diabetes patient in San Antonio was $44,767 in 2005. That's below the state average, which was $48,046. But it's noticeably higher than the national average, which was $39,401.
The average annual outpatient charges for San Antonians afflicted with Type 2 diabetes was $5,956 in 2005. That's significantly higher than the state average of $4,550. And it's way above the national average of $3,712.
Cost is not the only concern.
Nationally, the disparity between men and women afflicted with Type 2 diabetes is minimal (54.5 women vs. 45.5 percent men).
The disparity is much greater in the Alamo City, where 61 percent of the Type 2 population is female and only 39 percent is male.
Little dents
Texas Diabetes Institute officials say some 13 million people in the United States have been diagnosed with diabetes. Another 5.2 million people are currently undiagnosed.
According to the Centers for Disease Control, an average of 1 million new diabetes cases are diagnosed each year among people over the age of 20. Ninety percent are the Type 2 variety.
Four years ago, the negative financial impact created by diabetes in the United States was approximately $132 billion. Some $92 billion of that, Business Group on Health officials say, was spent on medical services alone.
As for the report, Business Group on Health Executive Director Marianne Fazen says it was developed to serve as a useful resource for Texas employers, many of whom are investing in worksite wellness and diabetes management programs as a way to help employees manage chronic conditions like diabetes more effectively.
She adds, "The bench-marking information presented in the report underscores the need to address this burgeoning health problem among working-age Texans."
In San Antonio, De La Haya says diabetes remains a serious problem.
But she adds, "We've made some little dents that are starting to make a big difference."
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