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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population
Incidence of periop bleeding, primary effectiveness composite endpoint, mITT population. Primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins \> 1.0 favors the treatment arm. 95% confidence interval (CI) and p-value are calculated accordingly. The win ratio is 1.07 (95% CI 0.72, 1.58), p=0.748.
Time frame: Through the first 48hrs post-operation
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Isolated Coronary Artery Bypass Grafting (I-CABG) Per Protocol (PP) Population
Incidence of periop bleeding, primary effectiveness composite endpoint, i--CABG population. The primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in the Sham arm. A ratio of wins \>1.0 favors the treatment arm. The win ratio was 1.33 (95% confidence interval 0.86, 2.04) p-value 0.202.
Time frame: Through the first 48hrs post operation
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population
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University of California, Davis Medical Center
Sacramento, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Mississippi
Jackson, Mississippi, United States
...and 19 more locations
Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers given below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins \>1.0 favors the treatment arm. The win ratio was 1.17 (95% confidence interval 0.79, 1.73) p value 0.451.
Time frame: Through the first 48 hours post-operation
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG Per Protocol (PP) Population
Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins \>1.0 favors the treatment arm. The win ratio was 1.59 (95% confidence interval 1.02, 2.46) p-value 0.041.
Time frame: Through the first 48hrs post-operation
Chest Tube Drainage, mITT Population
Drainage volume from all chest and mediastinal tubes
Time frame: Through 24hrs post-operation
Chest Tube Drainage, i-CABG PP Population
Drainage volume from all chest and mediastinal tubes
Time frame: Through 24hrs post-operation
Chest Tube Drainage, mITT Population
Drainage volume from all chest and mediastinal tubes
Time frame: Through 12hrs post-operation
Chest Tube Drainage, i-CABG PP Population
Drainage volume from all chest and mediastinal tubes
Time frame: Through 12hrs post-operation
Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population
Total PRBC transfusions (units) during hospitalization in the mITT population
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions, (Units) I-CABG PP Population
Total PRBC transfusions (units) during hospitalization
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units), mITT Population
Total Platelet transfusions (units) during hospitalization
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions, (Units), I-CABG PP Population
Total Platelet transfusions (units) during hospitalization
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks