Trial Purpose and Description
The primary objective of this clinical study is to compare the percentage of subjects with any component of a major morbidity composite in two treatment groups randomly allocated to receive preoperative supplementation of AT-III (Human) or Placebo.
Ages: 18 years and older
- Subject needs non-emergency cardiac surgery with cardiopulmonary bypass.
- Types of cardiac operations permitted:
- Complex/combined procedures (coronary artery bypass graft [CABG] plus valve), double/triple valve repair/replacements, ascending aorta/aortic arch surgeries (without baseline AT level restriction or preoperative heparin requirement). OR
- Isolated CABG or single valve repair/replacements are allowed only if either (a) AT level is less than 80% OR (b) preoperative heparin is received (unfractionated heparin [UFH] for at least 12 hours; low- molecular-weight heparin [LMWH] for more than 5 days).
- Subject needs emergency surgery.
- Subject needs heart transplantation.
- Use of minimally invasive surgery.
- Previous cardiac operation.
- Infective endocarditis.
- Thromboembolic events, stroke, or ST-elevated myocardial infarction within 7 days of surgery.
- Cardiogenic shock at the time of surgery.
- Renal dysfunction: Creatinine levels >2 mg/dL or chronic dialysis.
- Liver dysfunction: aspartate transaminase, alanine aminotransferase increase ≥2-fold above the upper-limit of local lab normal ranges.
- 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.
- Treatment with new oral anticoagulants (Apixaban, Rivaroxaban, Dabigatran) within 48 hours before surgery.
- Vitamin K antagonist therapy and an international normalized ratio >1.3 on the day of surgery.
- Platelet count <120,000/μL.
- History or suspicion of a congenital or acquired coagulation disorder.
- History of anaphylactic reaction(s) to blood or blood components.
- Allergies to excipients in the study drug.
- Refusal to receive allogenic transfusion of blood-derived products.
- Received AT treatment within the last 3 months prior to Screening visit.
Grifols Worldwide Operations (formerly Grifols Therapeutics)
Dates: 01/14/2016 - 11/30/2015
Last Updated: 01/15/2016
Study HIC#: 1504015669