Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)

Completed · Not applicable · Has a placebo group

Conditions studied: Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative

In brief

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).

Key facts

Study ID

NCT04976530

Run by

CytoSorbents, Inc

People needed

140

Starts

2021-08-31

Expected to finish

2023-08-07

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 18 years of age or older, with documented full, written informed consent
• Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)

You may not qualify if…

• CT surgery occurring 3 days or greater following ticagrelor discontinuation
• Heart-lung transplant procedures
• Procedures for implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
• Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis [HITT], perioperative platelet count < 50,000u/L, hemophilia, and international normalized ratio [INR] >1.5)
• Prohibited concomitant antithrombotic medications as defined in the study protocol
• Acute sickle cell crisis
• Known allergy to device components
• Active (untreated) systemic infection
• History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
• Women with positive pregnancy test during current admission or who are breast-feeding
• Life expectancy <30 days
• Inability to comply with requirements of the study protocol
• Treatment with investigational drug or device within 30 days of current surgery
• Previous enrollment in this trial

Where it is running

• 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

Full record on ClinicalTrials.gov

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