Blood Loss, Surgical Clinical Trial
— STAR-TOfficial 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
NCT number | NCT04976530 |
Other study ID # | 2021-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 31, 2021 |
Est. completion date | August 7, 2023 |
Verified date | January 2024 |
Source | CytoSorbents, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CytoSorbents, Inc |
United States, Canada,
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 |
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