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Completed
NCT04976530
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Conditions: Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: CytoSorbents, Inc
Location: University of California, Davis Medical Center Sacramento California
Summary
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (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 implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
4. Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis \[HITT\], perioperative platelet count \< 50,000u/L, hemophilia, and international normalized ratio \[INR\] \>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 \
Source: ClinicalTrials.gov (NCT04976530). StuddyBuddy aggregates publicly available trial information.