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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04976530
Other study ID # 2021-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date August 7, 2023

Study information

Verified date January 2024
Source CytoSorbents, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date August 7, 2023
Est. primary completion date August 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ventricular assist device (implant/revision of LVAD or RVAD) 4. Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and 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


Intervention

Device:
DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Sham comparator
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit

Locations

Country Name City State
Canada Hamilton General Hospital, Hamilton Health Sciences Corporation Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada London Health Sciences Centre, University Hospital London Ontario
Canada Montreal Heart Institute Montréal Quebec
Canada Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval Québec Quebec
Canada St. Michael's Hospital, Unity Health Toronto Toronto Ontario
Canada St. Boniface Hospital Winnipeg Manitoba
United States Emory University Hospital Midtown/Emory School of Medicine Atlanta Georgia
United States University of Maryland Medical Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Vermont Medical Center Burlington Vermont
United States Medical University of South Carolina Charleston South Carolina
United States University Hospitals, Cleveland Medical Center Cleveland Ohio
United States Lutheran Medical Group Fort Wayne Indiana
United States University of Iowa Iowa City Iowa
United States University of Mississippi Jackson Mississippi
United States University of Wisconsin-Madison Madison Wisconsin
United States Virtua Health Marlton New Jersey
United States The Medical College of Wisconsin, Inc. Milwaukee Wisconsin
United States Jersey Shore University Medical Center Neptune New Jersey
United States Yale New Haven Hospital New Haven Connecticut
United States New York University Langone Health New York New York
United States Baylor Scott & White The Heart Hospital Plano Plano Texas
United States Rhode Island Hospital Providence Rhode Island
United States VCU Medical Center Richmond Virginia
United States Carilion Clinic Roanoke Virginia
United States University of California, Davis Medical Center Sacramento California
United States MedStar Health Research Institute Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
CytoSorbents, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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