CLI 00125 ReCePI study (Heart Surgery) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the blood transfusion study device, INTERCEPT, and to see if it can help prevent infection after a transfusion of red blood cells.
What is the Condition Being Studied?
Cardiac Surgery

Who Can Participate in the Study?

- Adults 18+
- Scheduled for heart surgery with median sternotomy (vertical inline incision is made along the sternum)

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Be randomly assigned (like flipping a coin) to either Group 1 or Group 2
---Group 1 will get a transfusion of blood with the study device (INTERCEPT)
---Group 2 will get the standard of care transfusion
-Continue after-surgery care at the hospital at usual
-Complete 2 follow up visits on days 28 and 75 after leaving the hospital

Study Details

Full Title
A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study)
Principal Investigator
Anesthesiologist
Protocol Number
IRB: PRO00100741
NCT: NCT03459287
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698