Status:
TERMINATED
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Lead Sponsor:
CytoSorbents, Inc
Conditions:
Elective Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Cy...
Detailed Description
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinica...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03384875
Start Date
April 19 2018
End Date
January 18 2022
Last Update
December 4 2024
Active Locations (20)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
4
Iowa Heart Center
West Des Moines, Iowa, United States, 50266