StudyFinder
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Recruiting
18 years and over
Inclusion Criteria:
• Male or female 18 years of age or older, with documented full, written informed consent
• Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Exclusion Criteria:
• CT surgery occurring 3 days or greater following ticagrelor discontinuation
• Heart-lung transplant procedures
• Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
• Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5)
• 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
Device: DrugSorb-ATR system, Device: Sham comparator
Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative