Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Purpose
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).
Conditions
- Hemorrhage, Surgical
- Blood Loss, Surgical
- Blood Loss, Postoperative
- Hemorrhage Postoperative
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Sham Comparator Control |
Standard of care with Sham set-up |
|
Experimental DrugSorb-ATR Intervention |
Standard of care + DrugSorb-ATR system |
|
More Details
- Status
- Completed
- Sponsor
- CytoSorbents, Inc