Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
- Conditions
- Blood Loss, PostoperativeHemorrhage PostoperativeBlood Loss, SurgicalHemorrhage, Surgical
- Interventions
- Device: Sham comparatorDevice: DrugSorb-ATR system
- Registration Number
- NCT04976530
- Lead Sponsor
- CytoSorbents, Inc
- Brief Summary
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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)
- CT surgery occurring 3 days or greater following ticagrelor discontinuation
- Heart-lung transplant procedures
- Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
- Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Sham comparator Standard of care with Sham set-up DrugSorb-ATR Intervention DrugSorb-ATR system Standard of care + DrugSorb-ATR system
- Primary Outcome Measures
Name Time Method Incidence of peri-operative bleeding Through the first 48hrs post-operation Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint
- Secondary Outcome Measures
Name Time Method PRBC transfusions (units) Through to discharge from index hospitalization, on average 1-2 weeks Total PRBC transfusions (units) during hospitalization
Ticagrelor removal Through 30min post-CPB Change in blood ticagrelor levels
Platelet transfusions (units) Through to discharge from index hospitalization, on average 1-2 weeks Total Platelet transfusions (units) during hospitalization
Re-exploration for bleeding Through to discharge from index hospitalization, on average 1-2 weeks All surgical re-explorations for excessive bleeding, as classified by an independent CEC
Chest tube drainage Through 24hrs post-operation Drainage volume from all chest and mediastinal tubes
Incidence of moderate, severe, and massive peri-operative bleeding events Through the first day post-operation Peri-operative bleeding events classified according to the Universal Definition of Peri-operative Bleeding, and analyzed by class (Class 0; 1; 2; 3; 4)
PRBC transfusions (volume) Through to discharge from index hospitalization, on average 1-2 weeks Total PRBC transfusions (mL) during hospitalization
Platelet transfusions (volume) Through to discharge from index hospitalization, on average 1-2 weeks Total Platelet transfusions (mL) during hospitalization
Incidence of fatal peri-operative bleeding Through to discharge from index hospitalization, on average 1-2 weeks Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC
Trial Locations
- Locations (29)
MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
St. Michael's Hospital, Unity Health Toronto
🇨🇦Toronto, Ontario, Canada
University of Iowa
🇺🇸Iowa City, Iowa, United States
Baylor Scott & White The Heart Hospital Plano
🇺🇸Plano, Texas, United States
New York University Langone Health
🇺🇸New York, New York, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Virtua Health
🇺🇸Marlton, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Emory University Hospital Midtown/Emory School of Medicine
🇺🇸Atlanta, Georgia, United States
Lutheran Medical Group
🇺🇸Fort Wayne, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals, Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
The Medical College of Wisconsin, Inc.
🇺🇸Milwaukee, Wisconsin, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Hamilton General Hospital, Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre, University Hospital
🇨🇦London, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
🇨🇦Québec, Quebec, Canada
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Mississippi
🇺🇸Jackson, Mississippi, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
VCU Medical Center
🇺🇸Richmond, Virginia, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States