Status:
COMPLETED
ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement
Lead Sponsor:
The Cleveland Clinic
Conditions:
Mechanical Valve Replacement
Warfarin Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 replaceme...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- Patients meeting all the following will be considered for enrollment.
- Male or non-pregnant female (negative pregnancy test is required for women of child bearing potential) ≥ 18 of age who are able to provide informed consent and able to self-administer enoxaparin.
- Body weight ≥ 45kg and ≤ 150kg.
- Patients who are post prosthetic mechanical valve surgery and will need oral anticoagulation after discharge from the hospital.
- One who has undergone valve replacement with mechanical prosthesis in the mitral position.
- One who has undergone valve replacement with mechanical prosthesis in the aortic position.
- One who has undergone valve replacement with mechanical prosthesis in the tricuspid position.
Exclusion
- Patients with any of the following will not be eligible for enrollment in the study:
- Contraindication or sensitivity to unfractionated heparin/ low molecular weight heparin: history of heparin associated thrombocytopenia, heparin induced thrombocytopenia, or heparin induced thrombotic thrombocytopenia syndrome;
- History of, or current, cardiogenic shock;
- Active endocarditis (requiring \> 4 weeks of antibiotics);
- Active bleeding or bleeding diathesis;
- History of gastrointestinal bleeding and /or endoscopically verified ulcer disease within the last three months;
- Known proliferative diabetic retinopathy or history of intraocular bleeding;
- Ischemic stroke in the previous three months or any hemorrhagic stroke, known brain tumor, intracranial aneurysm or intracranial AV malformation;
- Renal insufficiency (cr clearance \< 30 cc/min), cr clearance calculation:
- Women = 0.85 x (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), Men = (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), or patient with a renal transplant;
- Anemia (Hgb \< 8 gm/dl);
- Thrombocytopenia (platelet count \< 100 x 109/L);
- Liver disease demonstrated by ALT \> 144u/L
- Uncontrolled hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>100mmHg);
- Life expectancy less than 6 months;
- Moderate pericardial effusion as diagnosed by echo;
- Concomitant use of clopidogrel, or cyclooxygenase 1 or 2 inhibitors or use within seven days;
- Non- medical exclusion
- Patients unable or unwilling to provide consent.
- Patients unable or unwilling to have follow-up echocardiogram.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00298285
End Date
October 1 2006
Last Update
November 9 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195