Mechanical Valve Replacement Clinical Trial
Official title:
ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement. A Pilot Study
The primary aim is to determine the rate of major bleeding and blood clots when using enoxaparin as a bridge to oral blood thinning medication in patients who have undergone mechanical valve replacement.
Patients who undergo mechanical heart valve replacement are usually placed on long-term oral
anticoagulation (blood thinning) medication to prevent blood clots from forming on the
mechanical valve. This is started in the hospital with intravenous unfractionated heparin;
patients must remain in the hospital while on unfractionated heparin. At the same time, an
oral blood thinner is started (warfarin). This process is commonly referred to as
"bridging." Once the warfarin reaches the proper level, the intravenous heparin is stopped.
This is a single center, non-randomized pilot study using twice a day enoxaparin injections
in place of unfractionated heparin as a bridge to warfarin therapy. A total of approximately
100 patients will be enrolled. Patients will be instructed how to give the enoxaparin
injections at home. Blood will be drawn every 1-2 days to monitor warfarin levels. Once
discharged, patients will continue to have their blood level checked until warfarin is at
the correct level, at which point enoxaparin will be discontinued. All patients who develop
signs or symptoms of a stroke or abnormal blood clotting will be asked to return for an
echocardiogram. An echocardiogram and 12-lead ECG will be done at approximately 30 days
after the start of the study.
Additionally the first 100 consecutive patients who fit the inclusion criteria but do not
consent to the enoxaparin strategy will be asked to enter a registry that will monitor their
hospital stay and information from their routine 30 day follow-up visit will be collected.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment