ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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 replacement.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

Patients meeting all the following will be considered for enrollment.

1. 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.

2. Body weight ≥ 45kg and ≤ 150kg.

3. 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 Criteria:

Patients with any of the following will not be eligible for enrollment in the study:

1. Contraindication or sensitivity to unfractionated heparin/ low molecular weight heparin: history of heparin associated thrombocytopenia, heparin induced thrombocytopenia, or heparin induced thrombotic thrombocytopenia syndrome;

2. History of, or current, cardiogenic shock;

3. Active endocarditis (requiring > 4 weeks of antibiotics);

4. Active bleeding or bleeding diathesis;

5. History of gastrointestinal bleeding and /or endoscopically verified ulcer disease within the last three months;

6. Known proliferative diabetic retinopathy or history of intraocular bleeding;

7. Ischemic stroke in the previous three months or any hemorrhagic stroke, known brain tumor, intracranial aneurysm or intracranial AV malformation;

8. 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;

9. Anemia (Hgb < 8 gm/dl);

10. Thrombocytopenia (platelet count < 100 x 109/L);

11. Liver disease demonstrated by ALT > 144u/L

12. Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg);

13. Life expectancy less than 6 months;

14. Moderate pericardial effusion as diagnosed by echo;

15. Concomitant use of clopidogrel, or cyclooxygenase 1 or 2 inhibitors or use within seven days;

Non- medical exclusion

1. Patients unable or unwilling to provide consent.

2. Patients unable or unwilling to have follow-up echocardiogram.