Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
The Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants (DOACs) Apixaban \& Rivaroxaban (STAR-D) study is a prospective, multicenter, double-blind, randomized study that evaluated the DrugSorb™-Antithrombotic Removal (ATR) device for removal of apixaban and rivaroxaban to reduce the likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery. The objectives were * To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose. * To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ\[DOAC\]) with the intraoperative use of DrugSorb-ATR. * To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Incidence of Perioperative Bleeding
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
Time frame: Through the first 48 hours post-operation
Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban
Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB
Time frame: Through 30 minutes post-CPB
Chest Tube Drainage
Drainage volume from all chest and mediastinal tubes
Time frame: Through 24 hours post-operation
Platelet Transfusions (Volume)
Total platelet transfusions (mL) during hospitalization
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units)
Total platelet transfusions (units) during hospitalization
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Packed Red Blood Cell (PRBC) Transfusions (Volume)
Total PRBC transfusions (mL) during hospitalization
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions (Units)
Total PRBC transfusions (units) during hospitalization
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
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University of California, Davis Medical Center
Sacramento, California, United States
University of Colorado
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
...and 17 more locations
Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events
Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)
Time frame: Through the first day post-operation
Surgical Re-exploration for Bleeding
All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Fatal Perioperative Bleeding
Deaths directly attributable to procedure-related bleeding.
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks