Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial
Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on
chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation
related to stopping oral anti-coagulant therapy is currently managed by using bridging
heparin therapy in patients with moderate to high risk of blood clot formation. There is a
substantial risk of bleeding in the pocket where the device is situated (pocket
hematoma)related to bridging therapy. The purpose of this study is to compare the current
standard of care of bridging with heparin to an experimental strategy of continuing coumadin
therapy in higher risk patients undergoing device surgery, with the hypothesis being that the
continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to
the bridging with heparin group.