Clinical trialNCT03384875TerminatedInterventional

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

SponsorCytoSorbents, IncEnrollment186Elective Cardiac Surgery

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Thomas Gleason, MD
not applicable- Unaffiliated with CytoSorbents
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

20 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Apr 2018
Primary completion: 18 Jan 2022
Completion: 18 Jan 2022
Last update posted: 4 Dec 2024
Registered enrollment: 186
Registry id: NCT03384875

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.