Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)

Not Applicable

Terminated

Conditions: Blood Loss, Postoperative
Hemorrhage Postoperative
Hemorrhage, Surgical
Blood Loss, Surgical

Interventions: Device: DrugSorb-ATR system
Device: Sham comparator

Registration Number: NCT05093504

Lead Sponsor: CytoSorbents, Inc

Brief Summary: 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

Detailed Description: The Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants (DOACs) Apixaban \& Rivaroxaban (STAR-D) study is a prospective, multicenter, double-blind, randomized study that evaluated the DrugSorb™-Antithrombotic Removal (ATR) device for removal of apixaban and rivaroxaban to reduce the likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery. The objectives were

* To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose.

* To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ\[DOAC\]) with the intraoperative use of DrugSorb-ATR.

* To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

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
Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device [LVAD] or right ventricular assist device [RVAD])
Any of the below conditions that pose a known risk for increased bleeding
1. Heparin induced thrombocytopenia
2. Preoperative platelet count <50,000u/L
3. Hemophilia
4. International normalized ratio (INR) greater than or equal to 1.8
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DrugSorb-ATR Intervention	DrugSorb-ATR system	Standard of care + DrugSorb-ATR system
Control	Sham comparator	Standard of care with Sham set-up

Primary Outcome Measures

Name	Time	Method
Incidence of Perioperative Bleeding	Through the first 48 hours post-operation	Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint

Secondary Outcome Measures

Name	Time	Method
Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban	Through 30 minutes post-CPB	Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB
Chest Tube Drainage	Through 24 hours post-operation	Drainage volume from all chest and mediastinal tubes
Platelet Transfusions (Volume)	Through to discharge from index hospitalization, on average 1-2 weeks	Total platelet transfusions (mL) during hospitalization
Platelet Transfusions (Units)	Through to discharge from index hospitalization, on average 1-2 weeks	Total platelet transfusions (units) during hospitalization
Packed Red Blood Cell (PRBC) Transfusions (Volume)	Through to discharge from index hospitalization, on average 1-2 weeks	Total PRBC transfusions (mL) during hospitalization
PRBC Transfusions (Units)	Through to discharge from index hospitalization, on average 1-2 weeks	Total PRBC transfusions (units) during hospitalization
Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events	Through the first day post-operation	Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)
Surgical Re-exploration for Bleeding	Through to discharge from index hospitalization, on average 1-2 weeks	All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee
Incidence of Fatal Perioperative Bleeding	Through to discharge from index hospitalization, on average 1-2 weeks	Deaths directly attributable to procedure-related bleeding.

Trial Locations

Locations (27): Emory Saint Joseph's Hospital
🇺🇸
Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States
Lutheran Medical Group
🇺🇸
Fort Wayne, Indiana, United States
Bryan Medical Center
🇺🇸
Lincoln, Nebraska, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
University Hospitals, Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
University of Mississippi
🇺🇸
Jackson, Mississippi, United States
Jersey Shore University Medical Center
🇺🇸
Neptune, New Jersey, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
🇺🇸
Miami, Florida, United States
Bethesda North Hospital, TriHealth, Inc
🇺🇸
Cincinnati, Ohio, United States
University of Colorado
🇺🇸
Denver, Colorado, United States
Emory University Hospital Midtown/Emory School of Medicine
🇺🇸
Atlanta, Georgia, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Virtua Health
🇺🇸
Marlton, New Jersey, United States
Baylor Scott & White The Heart Hospital
🇺🇸
Plano, Texas, United States
University of Wisconsin - Madison
🇺🇸
Madison, Wisconsin, United States
Advent Health
🇺🇸
Orlando, Florida, United States
St. Luke's Hospital of Kansas City
🇺🇸
Kansas City, Missouri, United States
University of California, Davis Medical Center
🇺🇸
Sacramento, California, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
VCU Medical Center
🇺🇸
Richmond, Virginia, United States
The Medical College of Wisconsin, Inc.
🇺🇸
Milwaukee, Wisconsin, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States