We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04976530
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
CytoSorbents, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Hemorrhage, Surgical Blood Loss, Surgical Blood Loss, Postoperative Hemorrhage Postoperative Device: DrugSorb-ATR system Device: Sham comparator Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Sorbent hemoperfusion system


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of peri-operative bleeding [ Time Frame: Through the first 48hrs post-operation ]
    Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint


Secondary Outcome Measures :
  1. Ticagrelor removal [ Time Frame: Through 30min post-CPB ]
    Change in blood ticagrelor levels

  2. Chest tube drainage [ Time Frame: Through 24hrs post-operation ]
    Drainage volume from all chest and mediastinal tubes

  3. PRBC transfusions (volume) [ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]
    Total PRBC transfusions (mL) during hospitalization

  4. PRBC transfusions (units) [ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]
    Total PRBC transfusions (units) during hospitalization

  5. Platelet transfusions (volume) [ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]
    Total Platelet transfusions (mL) during hospitalization

  6. Platelet transfusions (units) [ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]
    Total Platelet transfusions (units) during hospitalization

  7. Incidence of moderate, severe, and massive peri-operative bleeding events [ Time Frame: Through the first day post-operation ]
    Peri-operative bleeding events classified according to the Universal Definition of Peri-operative Bleeding, and analyzed by class (Class 0; 1; 2; 3; 4)

  8. 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 classified by an independent CEC

  9. Incidence of fatal peri-operative bleeding [ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]
    Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976530


Contacts
Layout table for location contacts
Contact: Susan Magosin, RN 1-732-997-6272 smagosin@cytosorbents.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
CytoSorbents, Inc
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT04976530    
Other Study ID Numbers: 2021-01
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
 Pathologic Processes
Intraoperative Complications
Postoperative Complications