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

Not available

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Study Start: 2021-12-27
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Male or female age 18 years or older, with documented full, written informed consent
2. 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)

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Exclusion Criteria

1. >48hrs between last apixaban or rivaroxaban dose and start of CT surgery

2. Patients on low dose apixaban or rivaroxaban for prophylactic indications

3. Heart-lung transplant procedures

4. Procedures for ventricular assist device (i.e., implant or revision of LVAD or RVAD)

5. 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. Hemophelia
   4. INR greater than or equal to 1.8

6. Prohibited concomitant antithrombotic medications as defined in the study protocol

7. Acute sickle cell crisis

8. Known allergy to device components

9. Active (untreated) systemic infection

10. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed

11. Women with positive pregnancy test during current admission or who are breast-feeding

12. Life expectancy <30 days

13. Inability to comply with requirements of the study protocol

14. Treatment with investigational drug or device within 30 days of current surgery

15. Previous enrollment in this trial

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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
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
Incidence of fatal perioperative bleeding	Through to discharge from index hospitalization, on average 1-2 weeks	Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC
DOAC drug removal: apixaban	Through 30 minutes post-CPB	Change in blood apixaban levels
DOAC drug removal: rivaroxaban	Through 30 minutes post-CPB	Change in blood rivaroxaban levels
Platelet transfusions (units)	Through to discharge from index hospitalization, on average 1-2 weeks	Total platelet transfusions (units) during hospitalization
PRBC transfusions (units)	Through to discharge from index hospitalization, on average 1-2 weeks	Total PRBC transfusions (units) during hospitalization
PRBC transfusions (volume)	Through to discharge from index hospitalization, on average 1-2 weeks	Total PRBC transfusions (mL) during hospitalization
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 CEC
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)

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