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January
Weatherly, Pa., Man is International Study’s First U.S. PatientLehigh Valley, Pa. (Jan. 24, 2006)Lehigh Valley Hospital (LVH) has enrolled the first patient in the U.S. in an international research study to gauge the safety and effectiveness of a synthetic blood clotting factor.The study is sponsored by Novo Nordisk, of Princeton, N.J. and Denmark, and is being conducted to learn if Factor XIII helps blood clots to stay strong during and after heart bypass surgery. A total of 50 patients worldwide will be recruited for this Phase One study. Factor XIII, also known as fibrin stabilizing factor, is critical to maintain blood clot strength. It plays a key role in stabilizing the strands of fibrin that weave a mesh around platelets after blood vessel injury. Without Factor XIII, fibrin strands are fragile, which allows them to break away and bleeding resumes. According to Nanette Schwann, M.D., lead investigator of the study at LVH and vice chair of research at LVH, the ultimate goal of the research is to decrease the number of patients that require blood transfusions during open heart surgery. “This has the long-range potential to improve outcomes in 500,000 patients who undergo coronary artery bypass surgery each year in the U.S.,” Schwann said. As many as 40 percent of bypass surgery patients require blood or blood products during the operation. “The transfusion of blood and blood products is well known to be associated with changes in the immune system and increase in rates of infection and disease transmission,” Schwann said. “Avoiding bleeding and the need for a transfusion can significantly improve outcomes after heart surgery.” The first enrolled patient, Wayne Nagle, of Weatherly, had bypass surgery at LVH performed by cardiothoracic surgeon James Wu, M.D., co-lead investigator, on Jan. 10. Prior to the surgery, Nagle, 68, agreed to participate in the study. “If this can help someone in the long run, I’m willing to be in the study,” says the retired lineman for PPL. During the operation, a solution of Factor XIII or a placebo (inactive substance) was administered after Nagle was taken off the heart-lung machine, Schwann said. “Since the study is double-blind, neither Dr. Wu, Mr. Nagle nor I know if he received the investigational Factor XIII or a placebo, but he did not receive a transfusion." A premier academic community hospital, Lehigh Valley Hospital and Health Network includes three hospital facilities – two in Allentown and one in Bethlehem, Pa. – and Lehigh Valley Health Services, providing home health, hospice, pharmaceutical and health management services. In 2005, US News & World Report named Lehigh Valley Hospital one of America’s Best Hospitals for the tenth straight year. LVHHN’s advanced regional resources include a Level I Trauma Center with added pediatric qualifications, regional Burn Center as well as kidney and pancreas transplant, perinatal/neonatal, cardiac, cancer care, and neurology and complex neurosurgery capabilities. LVHHN hospitals are designated national Magnet hospitals for excellence in nursing. LVH is one of Pennsylvania’s largest teaching hospitals and is a major teaching campus of Penn State's College of Medicine. This page last updated 2/19/08 09:47 PM
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