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-Antithrombotic Removal (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 Sex
All
Accepts Healthy Volunteers
No

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 implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD) 4. Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis [HITT], perioperative platelet count < 50,000u/L, hemophilia, and international normalized ratio [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

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
CytoSorbents, Inc

Study Contact

Detailed Description

Antithrombotic agents such as ticagrelor can increase the risk of surgical bleeding in patients undergoing CT surgery if there is not adequate washout time of the drug. Patients who require urgent surgery may not be able to wait for the recommended washout time (up to 7 days). The intraoperative use of the DrugSorb-ATR device to remove active ticagrelor may help reduce the risk of postoperative surgical bleeding in these patients.