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Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)

  • Study HIC#:2000031974
  • Last Updated:12/22/2022

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
  • Start Date06/21/2022
  • End Date03/31/2023

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:

  1. Male or female age 18 years or older, with documented full, written informed consent
  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:

  1. >48hrs between last apixaban or rivaroxaban dose and start of CT surgery
  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 LVAD or 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. Hemophelia
    4. 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

Principal Investigator

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