A five-year, $3.7 million clinical trial will investigate how to balance the benefits and risks of warfarin, a drug that helps prevent potentially deadly blood clots.
The multicenter study, led by researchers at Washington University School of Medicine in St. Louis, will evaluate customized warfarin dosage based on patient genetics and will test which range of blood clotting is optimal in orthopedic patients.
Blood clots contribute to the death of 100,000 Americans every year. Most of these deaths occur suddenly, so prevention with a blood thinner, or anticoagulant, such as warfarin (Coumadin) is widely regarded to be the best form of protection. However, a number of factors including drug interactions and genetics can interfere dangerously with warfarin, making it tricky to pinpoint the correct dose.
To help determine the best way to establish the right dose, knee or hip replacement surgery patients at Barnes-Jewish Hospital and several other institutions will be eligible to enroll in the Genetics InFormatics Trial of Warfarin (GIFT).
"Without any anticoagulant, orthopedic patients have a nearly 50 percent chance of having a blood clot after hip or knee replacement," says Brian Gage, MD, associate professor of medicine at Washington University and lead investigator of the trial. "These are the people at highest risk for blood clots, and because they've just had surgery they are also at high risk for bleeding. This balance is why this question of warfarin dosing is critical. Finding the right dose is like walking a tightrope."
The National Heart, Lung, and Blood Institute will fund the study. Collaborating institutions include the University of Utah, Intermountain Health Care, and the Hospital for Special Surgery in New York. Gage and colleagues hope to enroll 1,600 patients recovering from hip or knee replacement surgery, which will allow them to investigate two problems that make determining optimal warfarin dosage
|Contact: Gwen Ericson|
Washington University School of Medicine