CytoSorbents Corporation announced that its pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial has enrolled 80 patients, achieving the second of three key enrollment milestones, and triggering a pre-specified Data and Safety Monitoring Board (DSMB) safety review. The STAR-T trial intends to enroll approximately 120 patients at 30 centers in the U.S. and Canada to evaluate whether intraoperative use of DrugSorb®-ATR can reduce the high perioperative risk of bleeding in patients undergoing cardiothoracic surgery who have recently received the blood thinning agent, ticagrelor. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application, for which CytoSorbents received FDA Breakthrough Device Designation in April 2020, recognizing it as a major unmet medical need for which there are no FDA-approved or cleared therapies.