The Southeast Georgia Health System Brunswick Campus has been chosen as the only site in the southeastern U.S. to participate in the PURIFY-RCT study. The study will evaluate using the Seraph 100 Microbind Affinity Blood Filter to treat patients with bacteria in their bloodstream or who have developed septic shock. The Health System was chosen to participate in the multicenter study because it pioneered the use of Seraph 100 in patients with COVID-19.
“This world-class study puts Southeast Georgia Health System in an elite group of sites using this novel technology to impact a complicated disease process,” says Robert Ward, CEO at ExThera Medical Corporation, the device manufacturer.
Viruses, bacteria and fungi pathogens in the bloodstream pose great danger to hospitalized patients. In fact, septic shock caused by these pathogens is the leading cause of death worldwide. By cleansing the blood and reducing circulating pathogens in the bloodstream, the Seraph 100 may help regulate the immune system and prevent organ dysfunction. The treatment gives health care providers more time to treat the patient and improve their chance of survival.
The Seraph 100 received emergency use authorization (EUA) to treat seriously ill COVID-19 patients by the U.S. Food and Drug Administration in April 2020.
In August 2020, the Health System’s Medical Director of Critical Care, Stephen A. Chitty IV, M.D., began using Seraph to treat patients infected with the coronavirus. Chitty is a board-certified pulmonologist and critical care physician. In addition to serving on the Southeast Georgia Health System, Inc., board and the Quality and Patient Safety Operations Council, Chitty is the chair for the Quality Committee. He was recently honored with a Georgia Hospital Association Physician Hero Award.
Chitty used Seraph on nearly 80 patients infected with the coronavirus. Tapping the lessons he gleaned from those treatments, he authored a report* demonstrating that Seraph significantly reduced death in severe COVID-19 cases. Over a thousand patients worldwide have received Seraph treatment for COVID-19 to date.
“The Seraph device operates similarly to a dialysis filter that filters waste from the blood,” says Chitty. “It contains special beads that mimic the body’s endothelial structure in our immune system. As blood passes through the filter, pathogens cling to and are absorbed by those beads. This process removes the pathogens with little effect on blood cells, antibiotics, or other drugs the patient may be taking.”
Scott Raynes, MBA, MA, Health System president and CEO, adds, “The PURIFY-RCT study builds on Dr. Chitty’s previous clinical observations. This trial will advance care and improve outcomes for our critically ill patients. Without Dr. Chitty’s leadership, we would not have this innovative therapy in our community hospital. He spearheaded the effort to bring Seraph to our hospital and saved lives in the process.”
“The new study will compare two groups of intensive care patients: a larger group receiving Seraph treatment for up to four days, and a smaller group receiving normal intensive care,” explains Chitty. “Initially, we will look at shortening the length of hospital stays and the safety of the device. Further investigation will take place after the initial phase is completed and reviewed by the FDA.”
The study is funded by the Department of Defense, and sponsored by the Uniformed Services University, the Henry M. Jackson Foundation for the Advancement of Military Medicine and ExThera Medical Corporation, the filter’s manufacturer.
*Dr. Chitty served as the principal investigator and primary author of a clinical study titled, “A Multicenter Evaluation of Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: A Preliminary Report.”
Original source can be found here.
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