Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
NCT ID: NCT05093504
Last Updated: 2025-05-04
Study Results
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View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2021-12-27
2024-01-29
Brief Summary
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Detailed Description
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* To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose.
* To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ\[DOAC\]) with the intraoperative use of DrugSorb-ATR.
* To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Standard of care with Sham set-up
Sham comparator
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (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
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Sham comparator
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (\*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)
Exclusion Criteria
2. Patients on low dose apixaban or rivaroxaban for prophylactic indications
3. Heart-lung transplant procedures
4. Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device \[LVAD\] or right ventricular assist device \[RVAD\])
5. Any of the below conditions that pose a known risk for increased bleeding
1. Heparin induced thrombocytopenia
2. Preoperative platelet count \<50,000u/L
3. Hemophilia
4. International normalized ratio (INR) greater than or equal to 1.8
6. Prohibited concomitant antithrombotic medications as defined in the study protocol
7. Acute sickle cell crisis
8. Known allergy to device components
9. Active (untreated) systemic infection
10. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
11. Women with positive pregnancy test during current admission or who are breast-feeding
12. Life expectancy \<30 days
13. Inability to comply with requirements of the study protocol
14. Treatment with investigational drug or device within 30 days of current surgery
15. Previous enrollment in this trial
18 Years
ALL
No
Sponsors
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CytoSorbents, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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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
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
University of Colorado
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Lutheran Medical Group
Fort Wayne, Indiana, 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
Henry Ford Health System
Detroit, Michigan, United States
University of Mississippi
Jackson, Mississippi, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Bryan Medical Center
Lincoln, Nebraska, United States
Virtua Health
Marlton, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
Bethesda North Hospital, TriHealth, Inc
Cincinnati, Ohio, 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, Texas, United States
VCU Medical Center
Richmond, Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Countries
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References
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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
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-02
Identifier Type: -
Identifier Source: org_study_id
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