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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Standard of care with Sham set-up |
|
| DrugSorb-ATR Intervention | Experimental | Standard of care + DrugSorb-ATR system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DrugSorb-ATR system | Device | Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through the first 48hrs post operation |
| Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population |
| Measure | Description | Time Frame |
|---|---|---|
| Chest Tube Drainage, mITT Population | Drainage volume from all chest and mediastinal tubes | Through 24hrs post-operation |
| Chest Tube Drainage, i-CABG PP Population | Drainage volume from all chest and mediastinal tubes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Mack, MD | Baylor Scott & White The Heart Hospital | Principal Investigator |
| C. M Gibson, MD | Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School | Principal Investigator |
| Richard Whitlock, MD | Hamilton General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Yale New Haven Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41642317 | Derived | Mould DR, Sweeney KR, Prats J, Fan W, Schneider DJ, Storey RF, Deliargyris EN. Pharmacokinetic Modeling of Ticagrelor and Ticagrelor Active Metabolite Removal by the DrugSorb-ATR Device in a Randomized Controlled Study of Patients Undergoing Cardiac Surgery. J Cardiovasc Pharmacol. 2026 Feb 1;87(2):105-113. doi: 10.1097/FJC.0000000000001779. | |
| 35657375 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit |
| FG001 | DrugSorb-ATR Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2023 | Nov 5, 2024 |
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| Sham comparator | Device | Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit |
|
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. |
| 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. | Through the first 48hrs post-operation |
| Through 24hrs post-operation |
| Chest Tube Drainage, mITT Population | Drainage volume from all chest and mediastinal tubes | Through 12hrs post-operation |
| Chest Tube Drainage, i-CABG PP Population | Drainage volume from all chest and mediastinal tubes | Through 12hrs post-operation |
| Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population | Total PRBC transfusions (units) during hospitalization in the mITT population | 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 | 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 | 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 | From procedure start through to discharge from index hospitalization, on average 1-2 weeks |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University Hospital Midtown/Emory School of Medicine | Atlanta | Georgia | 30308 | United States |
| Lutheran Medical Group | Fort Wayne | Indiana | 46804 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Mississippi | Jackson | Mississippi | 39216 | United States |
| Virtua Health | Marlton | New Jersey | 08053 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| New York University Langone Health | New York | New York | 10016 | United States |
| University Hospitals, Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor Scott & White The Heart Hospital Plano | Plano | Texas | 75093 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| VCU Medical Center | Richmond | Virginia | 23219 | United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | United States |
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Hamilton General Hospital, Hamilton Health Sciences Corporation | Hamilton | Ontario | L8L 2X2 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre, University Hospital | London | Ontario | N6A 5A5 | Canada |
| St. Michael's Hospital, Unity Health Toronto | Toronto | Ontario | M5B 1W8 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval | Québec | Quebec | G1V 4G5 | Canada |
| Tripathi R, Morales J, Lee V, Gibson CM, Mack MJ, Schneider DJ, Douketis J, Sellke FW, Ohman ME, Thourani VH, Storey RF, Deliargyris EN. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036. |
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis population = modified intent to treat (mITT), ie, randomized subjects who had surgery and received a study device (control or intervention).
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit |
| BG001 | DrugSorb-ATR Intervention | Standard of care + DrugSorb-ATR system DrugSorb-Antithrombotic Removal (ATR) system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Heart failure | Count of Participants | Participants |
| ||||||||||||||||
| Coronary artery disease | Count of Participants | Participants |
| ||||||||||||||||
| Thrombocytopenia | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT, modified intent-to-treat | Posted | Number | number of wins | Through the first 48hrs post-operation |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | i-CABG, isolated CABG, per protocol population | Posted | Number | number of wins | Through the first 48hrs post operation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population | 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. | mITT, modified intent-to-treat | Posted | Number | number of wins | Through the first 48 hours post-operation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | i-CABG PP: subjects undergoing isolated CABG procedures, per protocol (those without major protocol deviations that would affect determination of device effectiveness. | Posted | Number | number of wins | Through the first 48hrs post-operation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Chest Tube Drainage, mITT Population | Drainage volume from all chest and mediastinal tubes | mITT (all enrolled subjects who received a study device) | Posted | Median | Full Range | mL | Through 24hrs post-operation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Chest Tube Drainage, i-CABG PP Population | Drainage volume from all chest and mediastinal tubes | isolated CABG per protocol population | Posted | Median | Full Range | mL | Through 24hrs post-operation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Chest Tube Drainage, mITT Population | Drainage volume from all chest and mediastinal tubes | mITT (all enrolled subjects who received a study device) | Posted | Median | Full Range | mL | Through 12hrs post-operation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Chest Tube Drainage, i-CABG PP Population | Drainage volume from all chest and mediastinal tubes | isolated CABG per protocol population | Posted | Median | Full Range | mL | Through 12hrs post-operation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population | Total PRBC transfusions (units) during hospitalization in the mITT population | mITT | Posted | Median | Full Range | PBRC Units | From procedure start through to discharge from index hospitalization, on average 1-2 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PRBC Transfusions, (Units) I-CABG PP Population | Total PRBC transfusions (units) during hospitalization | I-CABG PP, isolated CABG per protocol population | Posted | Median | Full Range | PRBC units | From procedure start through to discharge from index hospitalization, on average 1-2 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Transfusions (Units), mITT Population | Total Platelet transfusions (units) during hospitalization | mITT | Posted | Median | Full Range | PBRC units | From procedure start through to discharge from index hospitalization, on average 1-2 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Transfusions, (Units), I-CABG PP Population | Total Platelet transfusions (units) during hospitalization | I-CABG PP, isolated CABG per protocol population | Posted | Median | Full Range | Platelet units | From procedure start through to discharge from index hospitalization, on average 1-2 weeks |
|
|
30 days
The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit | 1 | 66 | 19 | 66 | 57 | 66 |
| EG001 | DrugSorb-ATR Intervention | Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit | 1 | 66 | 25 | 66 | 58 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MeDRA | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Shock haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vasoplegia syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post-procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cerebral vascular event | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Medical device site haemorrhage | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Paravalvular regurgitation | General disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MeDRA | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Investigations | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Blood albumin decreased | Vascular disorders | MedDRA | Systematic Assessment |
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| Protein total decreased | Vascular disorders | MedDRA | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Vasoplegia syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Anemia postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| General disorders and administration site conditions | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
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Ticagrelor blood levels comprise 99.8% protein-bound drug and 0.2% free, pharmacologically active drug. The device removes free ticagrelor and blood samples were collected during the study to assess reduction in free ticagrelor levels as a secondary endpoint. However, an assay that measures free ticagrelor is not commercially available and therefore data for free drug removal was not collected in the study.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weihong Fan | CytoSorbents Corp | 732-329-8885 | wfan@cytosorbents.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2023 | Nov 5, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
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| DrugSorb-ATR Intervention |
Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit |
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