CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT02566525

First Posted: October 2, 2015

Last Update Posted: July 6, 2017

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.

Information provided by (Responsible Party):

CytoSorbents, Inc

Purpose

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	Intervention
Elective Cardiac Surgery	Device: CytoSorb


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Further study details as provided by CytoSorbents, Inc:

Primary Outcome Measures:

Change in plasma free hemoglobin [ Time Frame: From Start of cardiopulmonary bypass procedure and end of cardiopulmonary bypass procedure (e.g. approximately 3 hours) ]
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:

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


Enrollment:	52
Study Start Date:	November 2015
Study Completion Date:	December 2016
Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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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

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


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


Responsible Party:	CytoSorbents, Inc
ClinicalTrials.gov Identifier:	NCT02566525 History of Changes
Other Study ID Numbers:	2015-001
First Submitted:	September 28, 2015
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

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