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

Blood Loss, Surgical Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976530
• Other study ID #: 2021-01
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: August 7, 2023

Study information

• Verified date: January 2024
• Source: CytoSorbents, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Postoperative
• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage Postoperative
• Hemorrhage, Surgical
• Postoperative Hemorrhage

Intervention

Device:
• DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
• Sham comparator
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit

Locations

Country	Name	City	State
Canada	Hamilton General Hospital, Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval	Québec	Quebec
Canada	St. Michael's Hospital, Unity Health Toronto	Toronto	Ontario
Canada	St. Boniface Hospital	Winnipeg	Manitoba
United States	Emory University Hospital Midtown/Emory School of Medicine	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Hospitals, Cleveland Medical Center	Cleveland	Ohio
United States	Lutheran Medical Group	Fort Wayne	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Mississippi	Jackson	Mississippi
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Virtua Health	Marlton	New Jersey
United States	The Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	New York University Langone Health	New York	New York
United States	Baylor Scott & White The Heart Hospital Plano	Plano	Texas
United States	Rhode Island Hospital	Providence	Rhode Island
United States	VCU Medical Center	Richmond	Virginia
United States	Carilion Clinic	Roanoke	Virginia
United States	University of California, Davis Medical Center	Sacramento	California
United States	MedStar Health Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ticagrelor removal	Change in blood ticagrelor levels	Through 30min post-CPB
Secondary	Chest tube drainage	Drainage volume from all chest and mediastinal tubes	Through 24hrs post-operation
Secondary	PRBC transfusions (volume)	Total PRBC transfusions (mL) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	PRBC transfusions (units)	Total PRBC transfusions (units) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	Platelet transfusions (volume)	Total Platelet transfusions (mL) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	Platelet transfusions (units)	Total Platelet transfusions (units) during hospitalization	Through to discharge from index hospitalization, on average 1-2 weeks
Secondary	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
Secondary	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
Secondary	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