Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Sabrina Evans, MD (ucdavis)

Description

Summary

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).

Official Title

Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor With the Intraoperative Use of the DrugSorb-ATR Device in Patients Undergoing On-pump Cardiothoracic Surgery Within Two Days of Ticagrelor Discontinuation

Keywords

Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative, Hemorrhage, Surgical Blood Loss, Postoperative Hemorrhage, DrugSorb-ATR system

Eligibility

You can join if…

Open to people ages 18 years and up

  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)

You CAN'T join if...

  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

Locations

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Baylor Scott & White The Heart Hospital Plano accepting new patients
    Plano Texas 75093 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CytoSorbents, Inc
ID
NCT04976530
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated