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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative

Intervention / Treatment
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* Device: DrugSorb-ATR system
* Device: Sham comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older, with documented full, written informed consent 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 Heart-lung transplant procedures Procedures for ventricular assist device (implant/revision of LVAD or RVAD) Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5) Prohibited concomitant antithrombotic medications as defined in the study protocol Acute sickle cell crisis Known allergy to device components Active (untreated) systemic infection History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed Women with positive pregnancy test during current admission or who are breast-feeding Life expectancy <30 days Inability to comply with requirements of the study protocol Treatment with investigational drug or device within 30 days of current surgery Previous enrollment in this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Standard of care with Sham set-up | Device: Sham comparator<br>* Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit<br>|
| Experimental: DrugSorb-ATR Intervention<br>Standard of care + DrugSorb-ATR system | Device: DrugSorb-ATR system<br>* Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit<br>* Other names: Sorbent hemoperfusion system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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