Back to resultsSafe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (STAR-T)
Primary Purpose
Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DrugSorb-ATR system
Sham comparator
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage, Surgical
Eligibility Criteria
Inclusion Criteria:
- Male or female 18 years of age or older, with documented full, written informed consent
- Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Exclusion Criteria:
- CT surgery occurring 3 days or greater following ticagrelor discontinuation
- Heart-lung transplant procedures
- Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
- Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5)
- 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
Sites / Locations
- University of California, Davis Medical Center
- Yale New Haven Hospital
- MedStar Health Research Institute
- Emory University Hospital Midtown/Emory School of Medicine
- Lutheran Medical Group
- University of Iowa
- University of Maryland Medical Center
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- University of Mississippi
- Virtua Health
- Jersey Shore University Medical Center
- New York University Langone Health
- University Hospitals, Cleveland Medical Center
- Rhode Island Hospital
- Medical University of South Carolina
- Baylor Scott & White The Heart Hospital Plano
- University of Vermont Medical Center
- VCU Medical Center
- Carilion Clinic
- University of Wisconsin-Madison
- The Medical College of Wisconsin, Inc.
- St. Boniface Hospital
- Hamilton General Hospital, Hamilton Health Sciences Corporation
- Kingston Health Sciences Centre
- London Health Sciences Centre, University Hospital
- St. Michael's Hospital, Unity Health Toronto
- Montreal Heart Institute
- Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
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 peri-operative bleeding
Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint
Secondary Outcome Measures
Ticagrelor removal
Change in blood ticagrelor levels
Chest tube drainage
Drainage volume from all chest and mediastinal tubes
PRBC transfusions (volume)
Total PRBC transfusions (mL) during hospitalization
PRBC transfusions (units)
Total PRBC transfusions (units) during hospitalization
Platelet transfusions (volume)
Total Platelet transfusions (mL) during hospitalization
Platelet transfusions (units)
Total Platelet transfusions (units) during hospitalization
Incidence of moderate, severe, and massive peri-operative bleeding events
Peri-operative bleeding events classified according to the Universal Definition of Peri-operative Bleeding, and analyzed by class (Class 0; 1; 2; 3; 4)
Re-exploration for bleeding
All surgical re-explorations for excessive bleeding, as classified by an independent CEC
Incidence of fatal peri-operative bleeding
Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04976530
Brief Title
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Acronym
STAR-T
Official Title
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor With the Intraoperative Use of the DrugSorb-ATR Device in Patients Undergoing On-pump Cardiothoracic Surgery Within Two Days of Ticagrelor Discontinuation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 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, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
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)
DrugSorb-ATR system
Other Intervention Name(s)
Sorbent hemoperfusion system
Intervention Description
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Intervention Type
Device
Intervention Name(s)
Sham comparator
Intervention Description
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
Primary Outcome Measure Information:
Title
Incidence of peri-operative bleeding
Description
Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint
Time Frame
Through the first 48hrs post-operation
Secondary Outcome Measure Information:
Title
Ticagrelor removal
Description
Change in blood ticagrelor levels
Time Frame
Through 30min post-CPB
Title
Chest tube drainage
Description
Drainage volume from all chest and mediastinal tubes
Time Frame
Through 24hrs post-operation
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
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
Incidence of moderate, severe, and massive peri-operative bleeding events
Description
Peri-operative bleeding events classified according to the Universal Definition of Peri-operative Bleeding, and analyzed by class (Class 0; 1; 2; 3; 4)
Time Frame
Through the first day post-operation
Title
Re-exploration for bleeding
Description
All surgical re-explorations for excessive bleeding, as classified by an independent CEC
Time Frame
Through to discharge from index hospitalization, on average 1-2 weeks
Title
Incidence of fatal peri-operative 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 18 years of age or older, with documented full, written informed consent
Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Exclusion Criteria:
CT surgery occurring 3 days or greater following ticagrelor discontinuation
Heart-lung transplant procedures
Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5)
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
First Name & Middle Initial & Last Name & Degree
Richard Whitlock, MD
Organizational Affiliation
Hamilton General Hospital
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
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
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
Lutheran Medical Group
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
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
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
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 Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
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
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Hamilton General Hospital, Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
St. Michael's Hospital, Unity Health Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
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 - Ticagrelor (STAR-T)
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