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Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Sponsor: CytoSorbents, Inc
Summary
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
Official title: Safe, Timely Antithrombotic Removal-Ticagrelor (STAR-T): Double-blind Randomized Study of Reduction in Bleeding by Ticagrelor Removal Via Intraop Use of DrugSorb-Antithrombotic Removal (ATR) in Cardiac Surgery Patients <2 Days of Drug Stop
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2021-08-31
Completion Date
2023-08-07
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Sham comparator
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
Locations (29)
University of California, Davis Medical Center
Sacramento, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Mississippi
Jackson, Mississippi, United States
Virtua Health
Marlton, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York University Langone Health
New York, New York, United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
VCU Medical Center
Richmond, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Hamilton General Hospital, Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec, Canada