Recently, the respected, peer-reviewed journalCirculation published the study “ Efficacy and Safety of a Four-Factor Prothrombin Complex Concentrate (4F-PCC) in Patients on Vitamin K Antagonists Presenting with Major Bleeding: A Randomized, Plasma-Controlled, Phase IIIb Study.” Its authors include Dr. T.J. Milling, deputy director and clinical scholar with the Seton/UT Southwestern Clinical Research Institute of Austin. Co-authors include leading researchers with the University of Rochester Medical Center in New York, Massachusetts General Hospital, University of Texas Southwestern and CSL Behring, a global firm specializing in biotheraputics (researchers are in both Pennsylvania and Marburg, Germany).
What does this mean for Seton and our patients? We went to the source and he explained it.
By Dr. T.J. Milling
This is a big picture example of clinical research keeping Seton Healthcare Family on the cutting edge of improving clinical care, of how being engaged in top-tier research helps us adopt new drugs the moment they are shown to be better than the old way.
Since 2007, we have been studying this new way to reverse coumadin, a blood thinner millions of people take because they are prone to clots in the lungs, legs or brain, i.e. stroke.
The problem with blood thinners is they make one prone to bleeding, so when patients on coumadin have a traffic accident or start bleeding inside their gastrointestinal tract for another reason, we have to reverse the coumadin very quickly.
The usual way is to give plasma and vitamin K, but plasma has to be thawed and matched to the patient’s blood type, a time consuming process when time really matters. In addition, the vitamin K takes hours to start working.
A prothrombin complex concentrate (PCC) is a condensed form of clotting factors – it’s kind of like boiling down plasma to a highly concentrated clotting factor soup. PCC has been shown in other countries and in small U.S. studies to be a better way to reverse coumadin very quickly, potentially saving thousands of American lives.
So with the sponsorship of CSL Behring, we performed a first-of-its-kind, large, randomized trial comparing plasma to PCC. This took five years to complete – and we enrolled more patients in Central Texas than anywhere else in the world.
The data from this trial led in March to U.S. Food and Drug Administration approval of this PCC (initially called Beriplex, now called KCentra because there is another product with a name similar to Beriplex). It also led to publication in Circulation, a respected, peer-reviewed, high impact scientific journal.
CSL Behring ramped up production of the drug, and Seton will be among the first hospital systems to receive it sometime in September – and among the first in America to use it outside the research protocol.
Because we were leading this project and, thus, knew in advance where it was likely going, we created a Seton working group with representatives from Pharmacy, Nursing, Emergency Medicine, Trauma and Neurology to create guidelines for using this new drug and a Compass order. A go-live deadline is Oct. 1 (I put my own cell phone number on the guidelines and order set to answer physician questions).
To my knowledge, no other hospitals will be this prepared, organized and ready to use this new drug safely and effectively – and that is because we led the research, so we were ready and able to do it.
It really is a clinical research and clinical care synergy success story, and it will save lives in Austin.