Hematoma Clinical Trial
Official title:
Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
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.
Eligible patients will be equally randomized (1:1) to the Conventional/control arm (bridging
anti-coagulation)or to the Experimental arm (continued coumadin). In the Conventional arm
there are 2 options. Patients with greater than 5 days pre-implant will discontinue oral
anti-coagulant (coumadin) 5 days before the procedure,and start full therapeutic doses of
subcutaneous low molecular weight heparin (LMWH)3 days before the procedure. Patients with
less than 5 days to implant can be given Vitamin K at the investigator's discretion and start
full therapeutic doses of either subcutaneous LMWH or IV unfractionated Heparin (choice is at
investigator discretion) when the INR is below the therapeutic range for the patient (usually
greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is
less than 1.6. Oral anti-coagulant (coumadin) will resume on the evening of the procedure.
Full dose LMWH injections or full dose IV heparin will be started 24 hours after surgery.
In the Experimental arm patients will continue on their oral anti-coagulant (coumadin). The
INR on the day of surgery will be < 3.0.
ASA will be continued in all patients. Plavix will be continued in patients with drug-eluting
stents.
Patients will be monitored for the development of any hematoma or bleeding event during
admission. There will be a unblinded team responsible for device implant and follow-up and a
blinded team responsible to monitor any bleeding events or hematoma and determine if it meets
the primary endpoint criteria for the study. The blinded team will have no knowledge of the
treatment arm and will be involved only if the patient develops a hematoma or bleeding event.
All hematomas and bleeding events will be followed until resolution.
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