Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

Exclusion Criteria

• •Confirmed pregnancy at time of randomization via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
• •Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
• •Intracranial neoplasm, arteriovenous malformation or aneurysm.
• •Dependency on renal dialysis or creatinine clearance \<30 mL/min.
• •Ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.
• •Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is \< 1.3 times control in the absence of heparin therapy.
• •Known allergy to Angiomax or hirudin-derived drugs, or known sensitivity to any component of the product.
• •Patients receiving clopidogrel (Plavix®) within the previous 5 days of randomization
• •Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 24 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®) of randomization.
• •Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to randomization.
• •Patients receiving LMWH or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
• •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
• •Refusal to undergo blood transfusion should it become necessary.
• •Any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
• •Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
• •Planned (\>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.