CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery

Stopped early · Not applicable

Conditions studied: Elective Cardiac Surgery

In brief

Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.

Key facts

Study ID

NCT03384875

Run by

CytoSorbents, Inc

People needed

186

Starts

2018-04-19

Expected to finish

2022-01-18

Last updated by the study team

2024-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled for non-emergent cardiac surgery requiring CPB for i) heart valve replacement with any other procedure, without hypothermic circulatory arrest (HCA), or ii) aortic reconstruction with or without another procedure, with HCA

You may not qualify if…

• Isolated Coronary Artery Bypass Graft
• Pregnant women
• Life expectancy of < 14 days
• End stage organ disease
• Active infection
• Correction of a congenital heart defect
• Contraindication to anticoagulation with heparin
• Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve replacement (TAVR)
• Declined informed consent

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Valley Hospital — Ridgewood, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Northwell Health: Lennox Hill Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• The Christ Hospital Linder Research Center — Cincinnati, Ohio, United States
• Ohio State university — Columbus, Ohio, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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