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

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
Northwell Health / North Shore University Hospital
Manhasset, New York 11030
Principal Investigator: Brian Lima, MD
Phone: 516-562-2345
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Manhasset, NY
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Brigham and Women's Hosp
75 Francis street
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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Boston, MA
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Baylor College of Medicine
1200 Moursund Street
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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Houston, TX
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Maine Medical Center
22 Bramhall St
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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Portland, ME
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University of Maryland
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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Baltimore, MD
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Cooper University Hospital
1 Cooper Plaza
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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from
Camden, NJ
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The Christ Hospital -Linder Research Center
2123 Auburn Avenue
Cincinnati, Ohio 45219
Principal Investigator: Geoffrey Answini, MD
Phone: 513-585-1778
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mi
from
Cincinnati, OH
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Ohio State University
281 W. Lane Ave
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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Columbus, OH
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Duke Univ Med Ctr
2301 Erwin Rd
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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Durham, NC
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Indiana University Health Methodist Hospital
Indianapolis, Indiana 46202
Principal Investigator: Joel Corvera, MD
Phone: 317-962-3586
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from
Indianapolis, IN
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St. Vincent Heart Center
Indianapolis, Indiana 46290
Principal Investigator: Sina Moainie, MD
Phone: 317-583-7804
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Indianapolis, IN
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University of Louisville
500 S Preston St
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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Louisville, KY
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Baptist Memorial Hospital
Memphis, Tennessee 38120
Principal Investigator: Edward Garett, MD
Phone: 901-226-1689
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Memphis, TN
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Vanderbilt University
2201 West End Ave
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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Nashville, TN
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Yale School of Medicine
New Haven, Connecticut 06520
Principal Investigator: Arnar Geirsson, MD
Phone: 203-737-8871
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New Haven, CT
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Columbia University Medical Center
630 W 168th St
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, NY
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Northwell Health: Lennox Hill Hospital
New York, New York 10075
Principal Investigator: Nirav Patel, MD
Phone: 212-434-6614
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New York, NY
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Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
Principal Investigator: Jonathan Philpott, MD
Phone: 757-388-8008
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Norfolk, VA
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Integris Baptist Medical Center
Oklahoma City, Oklahoma
Principal Investigator: David Vanhooser, MD
Phone: 405-951-8217
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Oklahoma City, OK
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Univ of Pennsylvania
3451 Walnut St
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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Philadelphia, PA
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University of Pittsburgh Medical Center
200 Lothrop St
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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Pittsburgh, PA
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Iowa Heart Center, P.C.
West Des Moines, Iowa 50266
Principal Investigator: Ganga Prabhakas, MD
Phone: 515-235-5114
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from
West Des Moines, IA
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