CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)

July 27, 2021 updated by: CytoSorbents, Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States
        • University Of Maryland
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Baystate Medical
    • New Jersey
      • Camden, New Jersey, United States
        • Cooper University Hospital
    • New York
      • New York, New York, United States
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)
30 Day All Cause Mortality
Time Frame: From time of enrollment through 30 days post procedure
Mortality within 30 Days of Surgery
From time of enrollment through 30 days post procedure
Adverse Event Rates
Time Frame: through 30 days
Total number of Serious Adverse Events
through 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours post start of cardiac bypass
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 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
2 hours post start of cardiac bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoSorbents, Inc

Investigators

  • Study Director: Steve Sisk, MSc Pharm, CytSorbents

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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