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

Primary Purpose

Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham comparator
DrugSorb-ATR system
Sponsored by
CytoSorbents, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis Medical Center
  • University of Colorado
  • Yale University
  • Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
  • Advent Health
  • University of South Florida
  • Emory University Hospital Midtown/Emory School of Medicine
  • Emory Saint Joseph's Hospital
  • Lutheran Medical Group
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • University of Mississippi
  • St. Luke's Hospital of Kansas City
  • Bryan Medical Center
  • Virtua Health
  • Jersey Shore University Medical Center
  • NYU Langone Medical Center
  • Bethesda North Hospital, TriHealth, Inc
  • University Hospitals, Cleveland Medical Center
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Baylor Scott & White The Heart Hospital
  • VCU Medical Center
  • University of Wisconsin - Madison
  • The Medical College of Wisconsin, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

DrugSorb-ATR Intervention

Arm Description

Standard of care with Sham set-up

Standard of care + DrugSorb-ATR system

Outcomes

Primary Outcome Measures

Incidence of perioperative bleeding
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint

Secondary Outcome Measures

DOAC drug removal: apixaban
Change in blood apixaban levels
DOAC drug removal: rivaroxaban
Change in blood rivaroxaban levels
Chest tube drainage
Drainage volume from all chest and mediastinal tubes
Platelet transfusions (volume)
Total platelet transfusions (mL) during hospitalization
Platelet transfusions (units)
Total platelet transfusions (units) during hospitalization
PRBC transfusions (volume)
Total PRBC transfusions (mL) during hospitalization
PRBC transfusions (units)
Total PRBC transfusions (units) during hospitalization
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)
Surgical re-exploration for bleeding
All surgical re-explorations for excessive bleeding, as adjudicated by an independent CEC
Incidence of fatal perioperative bleeding
Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC

Full Information

First Posted
October 1, 2021
Last Updated
September 22, 2023
Sponsor
CytoSorbents, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05093504
Brief Title
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoSorbents, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standard of care with Sham set-up
Arm Title
DrugSorb-ATR Intervention
Arm Type
Experimental
Arm Description
Standard of care + DrugSorb-ATR system
Intervention Type
Device
Intervention Name(s)
Sham comparator
Intervention Description
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
Intervention Type
Device
Intervention Name(s)
DrugSorb-ATR system
Other Intervention Name(s)
Sorbent hemoperfusion system
Intervention Description
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Primary Outcome Measure Information:
Title
Incidence of perioperative bleeding
Description
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
Time Frame
Through the first 48 hours post-operation
Secondary Outcome Measure Information:
Title
DOAC drug removal: apixaban
Description
Change in blood apixaban levels
Time Frame
Through 30 minutes post-CPB
Title
DOAC drug removal: rivaroxaban
Description
Change in blood rivaroxaban levels
Time Frame
Through 30 minutes post-CPB
Title
Chest tube drainage
Description
Drainage volume from all chest and mediastinal tubes
Time Frame
Through 24 hours post-operation
Title
Platelet transfusions (volume)
Description
Total platelet transfusions (mL) during hospitalization
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks
Title
Platelet transfusions (units)
Description
Total platelet transfusions (units) during hospitalization
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks
Title
PRBC transfusions (volume)
Description
Total PRBC transfusions (mL) during hospitalization
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks
Title
PRBC transfusions (units)
Description
Total PRBC transfusions (units) during hospitalization
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks
Title
Incidence of moderate, severe, and massive perioperative bleeding events
Description
Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)
Time Frame
Through the first day post-operation
Title
Surgical re-exploration for bleeding
Description
All surgical re-explorations for excessive bleeding, as adjudicated by an independent CEC
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks
Title
Incidence of fatal perioperative bleeding
Description
Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 LVAD or RVAD) Any of the below conditions that pose a known risk for increased bleeding Heparin induced thrombocytopenia Preoperative platelet count <50,000u/L Hemophelia 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mack, MD
Organizational Affiliation
Baylor Scott & White The Heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. M Gibson, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University Hospital Midtown/Emory School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Lutheran Medical Group
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Bryan Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Virtua Health
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Bethesda North Hospital, TriHealth, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University Hospitals, Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baylor Scott & White The Heart Hospital
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
The Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35657375
Citation
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.
Results Reference
derived

Learn more about this trial

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

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