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

  • End date
    Apr 9, 2022
  • participants needed
  • sponsor
    CytoSorbents, Inc
Updated on 9 April 2021


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.

Condition Elective Cardiac Surgery
Treatment CytoSorb
Clinical Study IdentifierNCT03384875
SponsorCytoSorbents, Inc
Last Modified on9 April 2021


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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