Clinical Trial Foreshadows Future of 
Biomedical Research in Austin

Seton and Austin-Based HPCR Collaborate to Enroll Patients in Worldwide Study

Results from a recent clinical trial will possibly change how patients on a common blood thinner are treated when suffering acute bleeding or in need of urgent surgical procedures, and hold importance for the future of biomedical research in Austin.

“This is an example of what happens as a medical community embraces clinical research and academic medicine,” said Dr. T.J. Milling, emergency physician at UMC Brackenridge and HPCR director of medical research. Photo: Seton Healthcare Family

The human 4-factor prothrombin complex concentrate (PCC) study ran in Austin by Hospital Physicians in Clinical Research (HPCR), the research arm of a multi-specialty physician group with a focus on emergency and critical care, in cooperation with the Seton Healthcare Family, found it as safe as plasma in reversing the effects of warfarin (Coumadin) 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, emergency physician at UMC Brackenridge and HPCR director of medical research. “This experience illustrates the pattern that we hope will be repeated again and again as Seton and HPCR become more active in clinical research.”

Milling is an author of several forthcoming scientific manuscripts reporting the results of the study.

A total of 79 medical and surgical patients were enrolled during 2008 and 2009 at Seton Medical Center Austin, UMC Brackenridge, Seton Northwest Hospital and Seton Medical Center Williamson. 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.

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. “It takes a lot of highly educated and skilled study coordinators to carry out these protocols,” Milling said.

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 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.

HPCR recently learned the National Institute of Neurological Disorders and Stroke (NINDS) has 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.

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