Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Stopped early · Not applicable · Has a placebo group
Conditions studied: Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
In brief
Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
Key facts
- Study ID
- NCT05093504
- Run by
- CytoSorbents, Inc
- People needed
- 9
- Starts
- 2021-12-27
- Expected to finish
- 2024-01-29
- Last updated by the study team
- 2025-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female age 18 years or older, with documented full, written informed consent
- 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)
You may not qualify if…
- >48hrs between last apixaban or rivaroxaban dose and start of CT surgery
- Patients on low dose apixaban or rivaroxaban for prophylactic indications
- Heart-lung transplant procedures
- Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device [LVAD] or right ventricular assist device [RVAD])
- Any of the below conditions that pose a known risk for increased bleeding
- Heparin induced thrombocytopenia
- Preoperative platelet count <50,000u/L
- Hemophilia
- International normalized ratio (INR) greater than or equal to 1.8
- 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
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.