CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | April 19, 2018 |
| End Date: | October 2020 |
| Contact: | Sally Palmer |
| Email: | spalmer@cytosorbents.com |
| Phone: | 732-398-5442 |
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be
randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus
treatment with the CytoSorb® device.
randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus
treatment with the CytoSorb® device.
Inclusion Criteria:
- Scheduled for non-emergent cardiac surgery requiring CPB for i) heart valve
replacement with any other procedure, without hypothermic circulatory arrest (HCA), or
ii) aortic reconstruction with or without another procedure, with HCA
Exclusion Criteria:
- Isolated Coronary Artery Bypass Graft
- Pregnant women
- Life expectancy of < 14 days
- End stage organ disease
- Active infection
- Correction of a congenital heart defect
- Contraindication to anticoagulation with heparin
- Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve
replacement (TAVR)
- Declined informed consent
We found this trial at
22
sites
2201 West End Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Clayton Kaiser, MD
Phone: 615-875-1727
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Nascimben Luigi, MD
Phone: 617-732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Scott LeMaire, MD
Phone: 832-355-9942
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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22 Bramhall St
Portland, Maine 04102
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Scott Buchanan, MD
Phone: 207-662-1489
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Ken Tanaka, MD
Phone: 410-328-4505
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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1 Cooper Plaza
Camden, New Jersey 08103
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Kinjal Patel, MD
Phone: 856-968-7333
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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2123 Auburn Avenue
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Principal Investigator: Geoffrey Answini, MD
Phone: 513-585-1778
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281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Gregory Rushing, MD
Phone: 614-292-0858
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Ian Welsby, MD
Phone: 919-681-4058
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Indianapolis, Indiana 46202
Principal Investigator: Joel Corvera, MD
Phone: 317-962-3586
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Indianapolis, Indiana 46290
Principal Investigator: Sina Moainie, MD
Phone: 317-583-7804
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500 S Preston St
Louisville, Kentucky
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Kristen Sell-Dottin, MD
Phone: 502-587-4106
University of Louisville The University of Louisville is a state supported research university located in...
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Manhasset, New York 11030
Principal Investigator: Brian Lima, MD
Phone: 516-562-2345
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Memphis, Tennessee 38120
Principal Investigator: Edward Garett, MD
Phone: 901-226-1689
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New Haven, Connecticut 06520
Principal Investigator: Arnar Geirsson, MD
Phone: 203-737-8871
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Michael Argenziano, MD
Phone: 212-305-3009
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10075
Principal Investigator: Nirav Patel, MD
Phone: 212-434-6614
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Norfolk, Virginia 23507
Principal Investigator: Jonathan Philpott, MD
Phone: 757-388-8008
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Oklahoma City, Oklahoma
Principal Investigator: David Vanhooser, MD
Phone: 405-951-8217
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Joseph Bavaria, MD
Phone: 215-662-2017
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Forozan Navid, MD
Phone: 412-623-2809
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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West Des Moines, Iowa 50266
Principal Investigator: Ganga Prabhakas, MD
Phone: 515-235-5114
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