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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cardiac Surgery, Cardiopulmonary Bypass

In brief

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III \[Human\]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who meet the study eligibility criteria were planned to be randomized to receive either AT-III (Human) or placebo.

Key facts

Study ID: NCT02037555
Run by: Grifols Therapeutics LLC
People needed: 425
Starts: 2014-06-26
Expected to finish: 2018-01-25
Last updated by the study team: 2019-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female.
At least 18 years of age.
Subject needed non-emergency cardiac surgery with CPB.
Types of cardiac operations permitted: complex/combined procedures (CABG+valve), double/triple valve repair/replacement, ascending aorta/aortic arch surgeries. Isolated CABG or single valve repair/replacements were allowed only if subject had received preoperative heparin >2 days.
Following the incorporation of Protocol Version 4.0 (Amendment 3 dated 02 Apr 2015), this criterion was revised to include complex/combined procedures (CABG+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 were allowed only if either (a) AT level was less than 80% OR (b) preoperative heparin was received ([UFH for at least 12 hours; LMWH for more than 5 days).
Subject had a baseline AT level of less than 80%.
Following incorporation of Protocol Version 3.0 (Amendment 2 dated 02 Sep 2014) this was changed to Subject had a Prescreening/Screening and baseline local lab AT level of less than 80%.
Following the incorporation of Protocol Version 4.0 (Amendment 3 dated 02 Apr 2015) this criterion was deleted and noted as "Not applicable - intentionally left blank for data management purposes (consistency in eCRF capture of eligibility criteria historically)."
Subject had signed informed consent form.
Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study.

You may not qualify if…

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

Where it is running

UC Irvine — Orange, California, United States
VA Medical Center - San Francisco — San Francisco, California, United States
Stanford University Hospital and Clinics — Stanford, California, United States
University of Colorado — Aurora, Colorado, United States
Yale University School of Medicine — New Haven, Connecticut, United States
University of Florida College of Medicine — Gainesville, Florida, United States
Jackson Memorial Hospital at University of Miami — Miami, Florida, United States
Emory University Hospital — Atlanta, Georgia, United States
Georgia Regents University — Augusta, Georgia, United States
Memorial Medical Center — Springfield, Illinois, United States
Indiana Ohio Heart — Fort Wayne, Indiana, United States
St. Vincent Heart Center of IN, LLC — Indianapolis, Indiana, United States
Kentucky Clinic — Lexington, Kentucky, United States
Tulane University Medical — New Orleans, Louisiana, United States
Maine Medical Center — Portland, Maine, United States
Brigham & Women's Hospital — Boston, Massachusetts, United States
Sparrow Clinical Research Institute — Lansing, Michigan, United States
William Beaumont Hospital — Royal Oak, Michigan, United States
Saint Luke's Hospital — Kansas City, Missouri, United States
Missouri Baptist Medical Center — St Louis, Missouri, United States
CHI Health Nebraska Heart Medical Office — Lincoln, Nebraska, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
North Shore University Hospital — New Hyde Park, New York, United States
Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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