Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
NCT ID: NCT04976530
Last Updated: 2025-04-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
140 participants
INTERVENTIONAL
2021-08-31
2023-08-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bleeding in Patients Undergoing CABG (Coronary Artery Bypass Graft) During Dual Antiplatelet Therapy
NCT02030548
Fibrinogen Early In Severe Trauma studY
NCT02745041
Thrombosomes® in Acute Thoracic Aortic Dissections
NCT05771831
Safe and Timely Antithrombotic Removal (STAR) Registry
NCT05077124
Fibrinogen Early In Severe Trauma studY Junior
NCT03508141
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Standard of care with Sham set-up
Sham comparator
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
DrugSorb-ATR Intervention
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Exclusion Criteria
2. Heart-lung transplant procedures
3. Procedures for implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
4. 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)
5. Prohibited concomitant antithrombotic medications as defined in the study protocol
6. Acute sickle cell crisis
7. Known allergy to device components
8. Active (untreated) systemic infection
9. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
10. Women with positive pregnancy test during current admission or who are breast-feeding
11. Life expectancy \<30 days
12. Inability to comply with requirements of the study protocol
13. Treatment with investigational drug or device within 30 days of current surgery
14. Previous enrollment in this trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CytoSorbents, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael J Mack, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott & White The Heart Hospital
C. M Gibson, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School
Richard Whitlock, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tripathi R, Morales J, Lee V, Gibson CM, Mack MJ, Schneider DJ, Douketis J, Sellke FW, Ohman ME, Thourani VH, Storey RF, Deliargyris EN. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.