CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)
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| ClinicalTrials.gov Identifier: NCT02566525 |
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Recruitment Status :
Completed
First Posted : October 2, 2015
Last Update Posted : July 6, 2017
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Sponsor:
CytoSorbents, Inc
Information provided by (Responsible Party):
CytoSorbents, Inc
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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 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: CytoSorb Device
Standard of care plus treatment with CytSorb device installed on the CPB machine
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Device: CytoSorb
Cytosorb device use during cardiopulmonary bypass |
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No Intervention: Control
Standard of care
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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) ]
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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
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 |
| Responsible Party: | CytoSorbents, Inc |
| ClinicalTrials.gov Identifier: | NCT02566525 History of Changes |
| Other Study ID Numbers: |
2015-001 |
| First Posted: | October 2, 2015 Key Record Dates |
| Last Update Posted: | July 6, 2017 |
| Last Verified: | July 2017 |
Keywords provided by CytoSorbents, Inc:
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CytoSorb device Plasma free hemoglobin inflammation extracorporeal bypass |