Antithrombotic Removal of Apixaban & Rivaroxaban for Bleeding

(STAR-D Trial)

Recruiting in Palo Alto (17 mi)

+27 other locations

Overseen by C. M Gibson, 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, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery

Eligibility Criteria

Inclusion Criteria

Male or female age 18 years or older, with documented full, written informed consent

Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)

Exclusion Criteria

>48hrs between last apixaban or rivaroxaban dose and start of CT surgery

Patients on low dose apixaban or rivaroxaban for prophylactic indications

Heart-lung transplant procedures

Participant Groups

Group I: DrugSorb-ATR Intervention Experimental Treatment 1 Intervention

Standard of care + DrugSorb-ATR system

Group II: Control Placebo Group 1 Intervention

Standard of care with Sham set-up

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Texas Health Science Center at Houston Houston, TX

Rhode Island Hospital Providence, RI

Baylor Scott & White The Heart Hospital Plano, TX

Yale University New Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

CytoSorbents, Inc Lead Sponsor

References