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

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

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Subject needs non-emergency cardiac surgery with cardiopulmonary bypass.
  • Types of cardiac operations permitted:
    1. 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
    2. 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).

Exclusion Criteria:

  • 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

Get Involved

For more information about this study, contact:
Karen B Stavris
+1 203-737-5037
karen.stavris@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Manuel Lopes Fontes

Principal Investigator

Sub-Investigators