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

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.


Participation Guidelines

Ages: 18 years and older

Gender: Both


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.

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Investigators

Manuel Lopes Fontes

Principal Investigator

Sub-Investigators