Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (STAR-T)

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

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).

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical; Blood Loss, Postoperative; Hemorrhage, Surgical; Hemorrhage Postoperative
• Intervention / Treatment: Device: DrugSorb-ATR system; Device: Sham comparator

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jodi Hoover; Phone Number: 732-783-4764; Email: jhoover@cytosorbents.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital, Hamilton Health Sciences Corporation
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital, Unity Health Toronto
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Health Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown/Emory School of Medicine
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Medical Group
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • 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
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • 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
      • New York University Langone Health
  • Ohio
    • 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 Plano
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • VCU Medical Center
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin-Madison
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female 18 years of age or older, with documented full, written informed consent
2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)

Exclusion Criteria:

1. CT surgery occurring 3 days or greater following ticagrelor discontinuation
2. Heart-lung transplant procedures
3. Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
4. Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5)
5. Prohibited concomitant antithrombotic medications as defined in the study protocol
6. Acute sickle cell crisis
7. Known allergy to device components
8. Active (untreated) systemic infection
9. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
10. Women with positive pregnancy test during current admission or who are breast-feeding
11. Life expectancy <30 days
12. Inability to comply with requirements of the study protocol
13. Treatment with investigational drug or device within 30 days of current surgery
14. Previous enrollment in this trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; Standard of care with Sham set-up	Device: Sham comparator; Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (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

Outcome Measure	Measure Description	Time Frame
Incidence of peri-operative bleeding	Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint	Through the first 48hrs post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRBC transfusions (volume)	Total PRBC transfusions (mL) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
PRBC transfusions (units)	Total PRBC transfusions (units) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Ticagrelor removal	Change in blood ticagrelor levels	Through 30min post-CPB
Chest tube drainage	Drainage volume from all chest and mediastinal tubes	Through 24hrs post-operation
Platelet transfusions (volume)	Total Platelet transfusions (mL) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Platelet transfusions (units)	Total Platelet transfusions (units) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
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)	Through the first day post-operation
Re-exploration for bleeding	All surgical re-explorations for excessive bleeding, as classified by an independent CEC	Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of fatal peri-operative 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

Collaborators and Investigators

• Sponsor: CytoSorbents, Inc
• Investigators: 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; Principal Investigator: Richard Whitlock, MD, Hamilton General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
• Other Study ID Numbers: 2021-01

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