Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass

Exclusion Criteria

• •1. Subject needed emergency surgery.
• •2. Subject needed heart transplantation.
• •3. Subject needed the use of minimally invasive surgery.
• •4. Subject had previous cardiac operation.
• •5. Subject had infective endocarditis.
• •6. Subject had thromboembolic events, stroke, or ST-elevated MI within 7 days of surgery.
• •7. Subject had cardiogenic shock at the time of surgery.
• •8. Subject had renal dysfunction: creatinine levels \>2 mg/dL or chronic dialysis.
• •9. Subject had liver dysfunction: aspartate aminotransferase (AST), alanine aminotransferase (ALT) increase ≥2-fold above the upper-limit of local lab normal ranges.
• •10. Subject had treatment with Clopidogrel® and Ticagrelor® within 5 days before surgery, Prasugrel® within 7 days before surgery, glycoprotein IIb/IIIa receptor blockers within 24 hours of surgery.
• •11. Subject had treatment with new oral anticoagulants (Apixaban®, Rivaroxaban®, Dabigatran®) within 48 hours before surgery.
• •12. Subject had Vitamin K antagonist therapy and an international normalized ratio (INR) \>1.3 on the day of surgery.
• •13. Subject had platelet count \<120,000/μL.
• •14. Subject had history or suspicion of a congenital or acquired coagulation disorder.
• •15. Subject had history of anaphylactic reaction(s) to blood or blood components.
• •16. Subject had allergies to excipients in the study drug.
• •17. Subject had refused to receive allogenic transfusion of blood-derived products.
• •18. Subject had received AT treatment within the last 3 months prior to Screening Visit.
• •19. Subject was pregnant. Subject had participated in any another investigational study within the last 3 months prior to Screening Visit.