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CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566525
Recruitment Status : Completed
First Posted : October 2, 2015
Results First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
CytoSorbents, Inc

Study Description
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Brief Summary:
Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.

Condition or disease Intervention/treatment Phase
Elective Cardiac Surgery Device: CytoSorb Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: CytoSorb Device
Standard of care plus treatment with CytSorb device installed on the CPB machine
 Device: CytoSorb
Cytosorb device use during cardiopulmonary bypass
No Intervention: Control
Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 30 Day All Cause Mortality [ Time Frame: From time of enrollment through 30 days post procedure ]
    Mortality within 30 Days of Surgery

  3. Adverse Event Rates [ Time Frame: through 30 days ]
    Total number of Serious Adverse Events


Other Outcome Measures:
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
CytoSorbents, Inc
Investigators
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Study Director: Steve Sisk, MSc Pharm CytSorbents
More Information
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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
Keywords provided by CytoSorbents, Inc:
CytoSorb device
Plasma free hemoglobin
inflammation
extracorporeal bypass