CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in plasma free hemoglobin [ Time Frame: From Start of cardiopulmonary bypass procedure and end of cardiopulmonary bypass procedure (e.g. approximately 3 hours) ]
2. Assessment of serious device related adverse events [ Time Frame: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days) ]

Secondary Outcome Measures :

1. Ventilator time [ Time Frame: From start of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) ]
2. Time in the ICU [ Time Frame: From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) ]
3. Days in the hospital [ Time Frame: From the end of the cardiopulmonary bypass procedure through hopsital discharge (e.g. ICU stay of approximately 4 days) ]
4. Incidence/progression of Acute Kidney Injury [ Time Frame: From Baseline through ICU discharge (e.g. ICU stay of approximately 4 days) ]
5. mortality [ Time Frame: From time of enrollment through 30 days post procedure ]
6. Adverse event rates [ Time Frame: through 30 days ]
7. Vital signs [ Time Frame: From Baseline through ICU discharge (e.g. ICU stay of approximately 4 days) ]
8. Safety Laboratory assessments [ Time Frame: From Baseline through ICU discharge (e.g. ICU stay of approximately 4 days) ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Study Director:	Steve Sisk, MSc Pharm	CytSorbents

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	CytoSorbents, Inc
ClinicalTrials.gov Identifier:	NCT02566525 History of Changes
Other Study ID Numbers:	2015-001
First Posted:	October 2, 2015
Last Update Posted:	July 6, 2017
Last Verified:	July 2017

Keywords provided by CytoSorbents, Inc:

CytoSorb device; Plasma free hemoglobin; inflammation; extracorporeal bypass