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Trial record 3 of 18 for:
cytosorb
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)
This study has been completed.
Sponsor:
CytoSorbents, Inc
Information provided by (Responsible Party):
CytoSorbents, Inc
ClinicalTrials.gov Identifier:
NCT02566525
First received: September 28, 2015
Last updated: July 5, 2017
Last verified: July 2017
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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:
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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02566525
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | September 28, 2015 |
| Last Updated: | July 5, 2017 |
Keywords provided by CytoSorbents, Inc:
|
CytoSorb device Plasma free hemoglobin inflammation extracorporeal bypass |
ClinicalTrials.gov processed this record on August 23, 2017