Grifols GTI1307

A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiac Surgery With Cardiopulmonary Bypass

Grifols GTI1307 [NCT02037555]

Description 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 will be randomized to receive either AT-III (Human) or placebo.

Biological: AT-III (Human)
Other: Placebo

Primary Investigator: Answini

Drug/Device Information
To evaluate the safety and efficacy of preoperative antithrombin supplementation in patients undergoing high-risk cardiac surgery with cardiopulmonary bypass
AT-III (Human)
Randomized into two treatment groups preoperatively in a 1:1 ratio: AT-III (Human) and Placebo
Grifols Therapeutics Inc.
Major Inclusion and Exclusion
Subject needs non-emergency cardiac surgery with cardiopulmonary bypass
Complex/combined procedures (CABG+valve), double/triple valve repair/replacements, ascending aorta/aortic arch surgeries
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 (UFH for at least 12 hours/LMWH for more than 5 days)
No previous cardiac operation
No thromboembolic events, stroke, or ST-elevated myocardial infarction within 7 days
No creatinine levels >2 mg/dL or chronic dialysis
No Clopidogrel and Ticagrelor within 5 days before surgery, Prasugrel within 7 days before surgery, glycoprotein IIb/IIIa receptor blockers within 24 hours
No Platelet count <120,000/µL
No history or suspicion of a congenital or acquired coagulation disorder