IRB #

IRB00010527

Title

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 (GTI-1307)

Principal Investigator

Frederick Tibayan

Study Purpose

The purpose of this study is to learn more about a study product that may prevent complications after complex cardiac surgery. The levels of Antithrombin III (AT-III), a naturally occurring blood thinner, can be too high or too low after people have complex cardiac surgery with cardiopulmonary bypass (CPB). CPB is used during cardiac surgery to keep blood flowing through the heart and lungs while the heart is being operated on. This study will determine if the study product helps maintain safe AT-III levels.

Medical Condition(s)

High-risk cardiac surgery requiring CPB
Keyword: Cardiovascular

Eligibility Criteria

Includes but not limited to:
-Male or female age 18+
-In need of non-emergency cardiac surgery requiring CPB
-Not in need of a heart transplant
-No history of cardiac surgery

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

About 7 weeks

Minors Included

No

Contact

Shobana Ganesan
Study Coordinator
(503) 494-4192

Sponsor

Grifols Therapeutics, Inc.

Recruitment End

04/30/2018

Compensation Provided

Yes

Compensation

You will be paid $25.00 after the Day 30 Visit


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