CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)
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ClinicalTrials.gov Identifier: NCT02566525 |
Recruitment Status :
Completed
First Posted : October 2, 2015
Results First Posted : August 20, 2021
Last Update Posted : August 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Elective Cardiac Surgery | Device: CytoSorb | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery |
Study Start Date : | November 2015 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: CytoSorb Device
Standard of care plus treatment with CytSorb device installed on the CPB machine
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Device: CytoSorb
Cytosorb device use during cardiopulmonary bypass |
No Intervention: Control
Standard of care
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- Assessment of Serious Device Related Adverse Events [ Time Frame: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days) ]The primary safety endpoint of this trial was to determine the product safety profile through the assessment of serious device related AEs through discharge from the ICU.
- Time in the ICU [ Time Frame: From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) ]Days in ICU, Post Surgery
- 30 Day All Cause Mortality [ Time Frame: From time of enrollment through 30 days post procedure ]Mortality within 30 Days of Surgery
- Adverse Event Rates [ Time Frame: through 30 days ]Total number of Serious Adverse Events
- Change in Complement Factor C3a - 2 Hours Post Start of CPB [ Time Frame: 2 hours post start of cardiac bypass ]Change in complement factor C3a - Sampling at 2 hours post start of CPB
- Change in Complement Factor C3a - 3 Hours Post Start of CPB [ Time Frame: 3 hours post start of CPB ]Change in complement factor C3a - Sampling at 3 hours post start of CPB
- Change in Complement Factor C5a - 2 Hours Post Start of CPB [ Time Frame: 2 hours post start of cardiac bypass ]Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of >180 minutes
Exclusion Criteria:
- Platelet count < 20,000/ uL
- Body mass index <18
- Pregnant women
- Life expectancy of <14 days
- End stage organ disease
- Active infection
- Undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (CABG) or single valve procedure
- Contraindication to anticoagulation with heparin
- Declined informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566525
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Baystate Medical | |
Springfield, Massachusetts, United States | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States | |
United States, New York | |
Columbia University | |
New York, New York, United States | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States |
Study Director: | Steve Sisk, MSc Pharm | CytSorbents |
Responsible Party: | CytoSorbents, Inc |
ClinicalTrials.gov Identifier: | NCT02566525 |
Other Study ID Numbers: |
2015-001 |
First Posted: | October 2, 2015 Key Record Dates |
Results First Posted: | August 20, 2021 |
Last Update Posted: | August 20, 2021 |
Last Verified: | July 2021 |
CytoSorb device Plasma free hemoglobin inflammation extracorporeal bypass |