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Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)

  • Study HIC#:2000031980
  • Last Updated:06/22/2022

Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).

  • Age18 years and older
  • GenderBoth
  • Start Date06/21/2022
  • End Date12/31/2022

Trial Purpose and Description

Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).

Eligibility Criteria

Inclusion Criteria:

  1. Male or female 18 years of age or older, with documented full, written informed consent
  2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)

Exclusion Criteria:

  1. CT surgery occurring 3 days or greater following ticagrelor discontinuation
  2. Heart-lung transplant procedures
  3. Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
  4. Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and 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

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