Antithrombotic Removal using DrugSorb-ATR system for Bleeding and Hemorrhage
(STAR-T Trial)
Recruiting in Palo Alto (17 mi)
+36 other locations
Overseen byMichael J Mack, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: CytoSorbents, Inc
No Placebo Group
Trial Summary
What is the purpose of this trial?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).
Eligibility Criteria
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
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
+11 more
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DrugSorb-ATR InterventionExperimental Treatment1 Intervention
Standard of care + DrugSorb-ATR system
Group II: ControlPlacebo Group1 Intervention
Standard of care with Sham set-up
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Minneapolis Heart Institute FoundationMinneapolis, MN
University of MichiganAnn Arbor, MI
The Ohio State University Wexner Medical CenterColumbus, OH
The University of Texas Health Science Center at HoustonHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
CytoSorbents, IncLead Sponsor