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

NCT05093504 | Terminated Results DMC FDA Device

• 1 other identifier: 2021-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 27

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

Conditions

Hemorrhage, Surgical; Hemorrhage Postoperative; Blood Loss, Surgical; Blood Loss, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban

  Through 30 minutes post-CPB

• Chest Tube Drainage

  Through 24 hours post-operation

• Platelet Transfusions (Volume)

  Through to discharge from index hospitalization, on average 1-2 weeks

• Platelet Transfusions (Units)

  Through to discharge from index hospitalization, on average 1-2 weeks

• Packed Red Blood Cell (PRBC) Transfusions (Volume)

  Through to discharge from index hospitalization, on average 1-2 weeks

Study Arms (2)

Control

SHAM COMPARATOR

Standard of care with Sham set-up

Device: Sham comparator

DrugSorb-ATR Intervention

EXPERIMENTAL

Standard of care + DrugSorb-ATR system

Device: DrugSorb-ATR system

Interventions

Sham comparator DEVICE

Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit

Control

DrugSorb-ATR system DEVICE

Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit

Also known as: Sorbent hemoperfusion system

DrugSorb-ATR Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \>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
• Heparin induced thrombocytopenia
• Preoperative platelet count \<50,000u/L
• Hemophilia
• 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

Sponsors & Collaborators

• CytoSorbents, Inc: lead

Study Sites (27)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Advent Health

Orlando, Florida, 32803, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University Hospital Midtown/Emory School of Medicine

Atlanta, Georgia, 30308, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Lutheran Medical Group

Fort Wayne, Indiana, 46804, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

Location

Virtua Health

Marlton, New Jersey, 08053, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Bethesda North Hospital, TriHealth, Inc

Cincinnati, Ohio, 45242, United States

Location

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor Scott & White The Heart Hospital

Plano, Texas, 75093, United States

Location

VCU Medical Center

Richmond, Virginia, 23219, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Tripathi R, Morales J, Lee V, Gibson CM, Mack MJ, Schneider DJ, Douketis J, Sellke FW, Ohman ME, Thourani VH, Storey RF, Deliargyris EN. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036.

  PMID: 35657375 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Limitations and Caveats

The study was terminated early for business reasons, due to low enrollment. Outcome data was not cleaned, nor adjudicated. The only outcome available to analyze was the percent change in drug levels for both direct oral anticoagulants or DOACs rivaroxaban and apixaban together--there were not enough subjects to analyze DOAC levels separately.

Results Point of Contact

• Title: Weihong Fan
• Organization: CytoSorbents

wfan@cytosorbents.com

1 732-329-888

Study Officials

• Michael J Mack, MD

  Baylor Scott & White The Heart Hospital

  PRINCIPAL INVESTIGATOR

• C. M Gibson, MD

  Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 26, 2021
• Study Start: December 27, 2021
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)