Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients

Trial ID or NCT#

NCT03459287

Status

not recruiting iconNOT RECRUITING

Purpose

The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.

Official 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

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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Investigator(s)

Ronald Pearl
Ronald Pearl
Anesthesiologist
Dr. Richard K. and Erika N. Richards Professor
Anil K. Panigrahi
Anesthesiologist
Clinical Professor, Anesthesiology, Perioperative and Pain Medicine Clinical Associate Professor (By courtesy), Pathology

Contact us to find out if this trial is right for you.

Contact

Ronald Pearl, Dr

View on ClinicalTrials.gov