What is the purpose of this trial?
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.
Ages: 18 years and older
Grifols Worldwide Operations (formerly Grifols Therapeutics)
Dates: 01/14/2016 - 11/30/2017
Last Updated: 02/22/2018
Study HIC#: 1504015669