News Clinical Trial Involving Four Seton Hospitals Points to Bright Research Future

A recent clinical trial managed locally by Hospital Physicians in Clinical Research (HPCR) in cooperation with Seton Healthcare Family will likely change how patients on a common blood thinner are treated when they suffer acute bleeding or need urgent surgical procedures.

Those at risk for blood clots or who are prone to strokes are commonly treated with warfarin, also known as coumadin. However, when such patients begin bleeding from a trauma such as an auto accident or other medical causes, doctors need to make the blood thicker to encourage clotting. Researchers have sought faster and easier ways to do this than using plasma, which takes precious time to administer.

The study found that a human 4-factor prothrombin complex concentrate (PCC) is at least as safe as plasma in reversing the effects of warfarin and is faster and easier to give to patients.

The trial has important implications for the future of biomedical research in Austin. Community leaders are calling for a new medical school to be built in Austin, along with a new teaching hospital to replace University Medical Center Brackenridge, which would open new opportunities for research.

"This is an example of what happens as a medical community embraces clinical research and academic medicine," said Dr. T.J. Milling, HPCR director of medical research and a UMC Brackenridge emergency physician. "This experience illustrates the pattern that we hope will be repeated again and again as Seton and HPCR become more active in clinical research."

"You cannot successfully carry out this level of research without the support of our excellent nursing staff," Milling added. "It is and always has been a great honor and pleasure to work with these consummate professionals in the Seton family."
Milling is an author of several forthcoming scientific manuscripts reporting the results of the study. He recently was interviewed about this study on KXAN-TV.

HPCR is a wholly-owned subsidiary of Emergency Service Partners, L.P., whose physicians enrolled more patients in the Austin area than in any of the other study sites worldwide. A total of 79 medical and surgical patients were enrolled during 2008 and 2009 at Seton Medical Center Austin, University Medical Center Brackenridge, Seton Northwest Hospital and Seton Medical Center Williamson.

The study's sponsor, CSL Behring, recently applied for U.S. Food and Drug Administration (FDA) approval of the biotherapy, which would be the first of its kind in the U.S. to be approved to reverse the effects of warfarin. More than 2 million Americans take warfarin, often to reduce the likelihood of blood clots, and roughly 2 to 3 percent of those patients experience bleeding complications every year.

Such clinical trials can benefit the local community by giving patients access to new medical therapies both during the study and more quickly afterward. The number of clinical trials within Seton Healthcare Family now number more than 400 and counting, with Seton's Office of Research Administration and the University of Texas Southwestern's Clinical Research Institute providing support and oversight. Milling also is a UT Southwestern Austin faculty member.

"Our physicians will adopt the use of this 4-factor PCC immediately if the FDA approves it, while centers that did not take part in the research may not do so for years," Milling said, noting that it usually takes more than a decade for best practices and new therapies to achieve widespread adoption in the medical community.

In addition, more clinical research in the Austin area is likely to create jobs. Milling said, "It takes a lot of highly educated and skilled study coordinators to carry out these protocols."

Now that the medical portion of the study is complete, Milling and his coauthors around the country are presenting the results at national scientific meetings and writing manuscripts for publication in major academic medical journals. A poster presentation was given at the Thrombosis and Hemostasis Summit of North America, May 3-5 in Chicago. The research also was one of only 27 abstracts accepted from among more than 700 submitted for oral presentation at the annual American College of Emergency Physicians (ACEP) Scientific Assembly in October in Denver.

"Based on this publicity, we expect that Seton and HPCR will be asked to participate in many more trials," Milling said. For example, HPCR recently learned that the National Institute of Neurological Disorders and Stroke (NINDS) named Austin as a selected back-up site for the Neurological Emergencies Treatment Trials (NETT) network. This paves the way for future involvement by HPCR and Seton in more neurologic studies such as the RAMPART seizure trial, which was published in February in the New England Journal of Medicine.