CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CytoSorb Device |
Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine |
|
|
Placebo Comparator Control |
Standard of care |
|
More Details
- Status
- Terminated
- Sponsor
- CytoSorbents, Inc