Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
- Study HIC#:2000031974
- Last Updated:01/08/2024
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
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Ricarda Tomlin
- Phone Number: 1-203-785-2073
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Trial Purpose and Description
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
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- >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 LVAD or RVAD)
- Any of the below conditions that pose a known risk for increased bleeding
- Heparin induced thrombocytopenia
- Preoperative platelet count <50,000u/L
- Hemophelia
- 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