A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

Date Added
August 7th, 2024
PRO Number
Pro00137409
Researcher
Harold Szerlip

List of Studies

Keywords
Coronary Artery Disease, Surgery
Summary

Up to 67% of patients undergoing heart surgery may experience complications after surgery. These complications may include longer stay in the intensive care unit (ICU), more time on a ventilator (also known as a breathing machine), longer overall stay in the hospital, having to return to the hospital soon after being discharged, and even death.

This research study is being performed to see whether RBT-1, an investigational new drug, can reduce complications after heart surgery

In this research study, you will have a 50% chance of being assigned to receive RBT-1 and a 50% chance of being assigned to receive placebo.

If you decide to participate, you will receive a single intravenous (IV) infusion (an infusion into your vein) of either: 1) RBT-1 at a dose level of 45 mg SnPP/240 mg FeS or 2) placebo in the form of normal saline (salt water solution). You cannot choose whether you are given RBT-1 or placebo.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
8437928166
pregulma@musc.edu



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