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

April 17, 2025 updated by: CytoSorbents, Inc

Safe & Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D): Prospective, Multicenter, Double-blind, Randomized Study of Apixaban & Rivaroxaban Removal to Reduce Risk of Serious Bleeding in Urgent Cardiac Surgery Patients

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
      • Orlando, Florida, United States, 32803
        • Advent Health
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown/Emory School of Medicine
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Medical Group
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital of Kansas City
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Medical Center
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Virtua Health
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital, TriHealth, Inc
      • Cleveland, Ohio, United States, 44106
        • University Hospitals, Cleveland Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Plano, Texas, United States, 75093
        • Baylor Scott & White The Heart Hospital
    • Virginia
      • Richmond, Virginia, United States, 23219
        • VCU Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison
      • Milwaukee, Wisconsin, United States, 53226
        • The Medical College of Wisconsin, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 left ventricular assist device [LVAD] or right ventricular assist device [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. Hemophilia
    4. International normalized ratio (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control
Standard of care with Sham set-up
Device: Sham comparator
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
Experimental: DrugSorb-ATR Intervention
Standard of care + DrugSorb-ATR system
Device: DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Other Names:
  • Sorbent hemoperfusion system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Perioperative Bleeding
Time Frame: Through the first 48 hours post-operation
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
Through the first 48 hours post-operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban
Time Frame: 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
Through 30 minutes post-CPB
Chest Tube Drainage
Time Frame: Through 24 hours post-operation
Drainage volume from all chest and mediastinal tubes
Through 24 hours post-operation
Platelet Transfusions (Volume)
Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks
Total platelet transfusions (mL) during hospitalization
Through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units)
Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks
Total platelet transfusions (units) during hospitalization
Through to discharge from index hospitalization, on average 1-2 weeks
Packed Red Blood Cell (PRBC) Transfusions (Volume)
Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks
Total PRBC transfusions (mL) during hospitalization
Through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions (Units)
Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks
Total PRBC transfusions (units) during hospitalization
Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events
Time Frame: 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)
Through the first day post-operation
Surgical Re-exploration for Bleeding
Time Frame: 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
Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Fatal Perioperative Bleeding
Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks
Deaths directly attributable to procedure-related bleeding.
Through to discharge from index hospitalization, on average 1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CytoSorbents, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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