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

Blood Loss, Surgical Clinical Trial

— STAR-D  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05093504
• Other study ID #: 2021-02
• Status: Terminated
• Phase: N/A
• Start date: December 27, 2021
• Est. completion date: January 29, 2024

Study information

• Verified date: February 2024
• Source: CytoSorbents, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• Blood Loss, Postoperative
• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage Postoperative
• Hemorrhage, Surgical
• Postoperative Hemorrhage

Intervention

Device:
• Sham comparator
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
• DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of perioperative bleeding	Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint	Through the first 48 hours post-operation
Secondary	DOAC drug removal: apixaban	Change in blood apixaban levels	Through 30 minutes post-CPB
Secondary	DOAC drug removal: rivaroxaban	Change in blood rivaroxaban levels	Through 30 minutes post-CPB
Secondary	Chest tube drainage	Drainage volume from all chest and mediastinal tubes	Through 24 hours post-operation
Secondary	Platelet transfusions (volume)	Total platelet transfusions (mL) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	Platelet transfusions (units)	Total platelet transfusions (units) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	PRBC transfusions (volume)	Total PRBC transfusions (mL) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	PRBC transfusions (units)	Total PRBC transfusions (units) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	Incidence of moderate, severe, and massive perioperative bleeding events	Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)	Through the first day post-operation
Secondary	Surgical re-exploration for bleeding	All surgical re-explorations for excessive bleeding, as adjudicated by an independent CEC	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	Incidence of fatal perioperative bleeding	Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC	Through to discharge from index hospitalization, on average 1-2 weeks