CytoSorbents has won FDA approval to conduct a pivotal trial for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiothoracic surgery with the polymer adsorption technology.
The STAR-T will enroll up to 120 patients across 20 clinical sites. The primary endpoint of the study will evaluate whether the use of DrugSorb-ATR with the standard of care in patients on ticagrelor undergoing cardiothoracic surgery reduces the risk of peri-operative bleeding complications compared to standard of care alone.
The trial will also evaluate reductions in ticagrelor blood levels and a number of additional outcomes to capture the full potential clinical and cost-economic benefits of DrugSorb-ATR.
The MonMouth Junction, NJ-based company won breakthrough device designation to remove ticagrelor during cardiothoracic surgery in April of 2020.
"Performing cardiac surgery in patients while on antithrombotic agents such as ticagrelor is a major issue at every U.S. cardiac surgery center due to the very high risk of perioperative bleeding,” said Michael Mack, MD, Chair of Cardiovascular Service Line at Baylor Scott & White Health, President of Baylor Scott & White Research Institute, and Principal Co-Investigator of the STAR-T study. “Such bleeding is a major cause of morbidity, mortality and added costs, and is a vexing patient management problem for cardiac surgeons worldwide. Currently we have to either delay surgery until the effects of the antithrombotic agent wear off, or if the patient cannot wait due to the urgency of their condition, proceed with the elevated bleeding risk. The STAR-T study will evaluate whether intraoperative removal of ticagrelor with DrugSorb-ATR can safely reduce bleeding complications. We designed the STAR-T trial with the rigor of a randomized controlled trial to generate the highest level of evidence to determine outcomes that will hopefully benefit every heart center worldwide."