Clinical trial NCT04976530: Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Official title: Safe, Timely Antithrombotic Removal-Ticagrelor (STAR-T): Double-blind Randomized Study of Reduction in Bleeding by Ticagrelor Removal Via Intraop Use of DrugSorb-Antithrombotic Removal (ATR) in Cardiac Surgery Patients <2 Days of Drug Stop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage, Surgical
Blood Loss, Surgical
Blood Loss, Postoperative
Hemorrhage Postoperative
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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 implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
4. Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis \[HITT\], perioperative platelet count \< 50,000u/L, hemophilia, and international normalized ratio \[INR\] \>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

Primary outcomes:
measure: Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population
timeFrame: Through the first 48hrs post-operation
measure: Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Isolated Coronary Artery Bypass Grafting (I-CABG) Per Protocol (PP) Population
timeFrame: Through the first 48hrs post operation
measure: Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population
timeFrame: Through the first 48 hours post-operation
measure: Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG Per Protocol (PP) Population
timeFrame: Through the first 48hrs post-operation
Secondary outcomes:
measure: Chest Tube Drainage, mITT Population
timeFrame: Through 24hrs post-operation
measure: Chest Tube Drainage, i-CABG PP Population
timeFrame: Through 24hrs post-operation
measure: Chest Tube Drainage, mITT Population
timeFrame: Through 12hrs post-operation
measure: Chest Tube Drainage, i-CABG PP Population
timeFrame: Through 12hrs post-operation
measure: Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population
timeFrame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
measure: PRBC Transfusions, (Units) I-CABG PP Population
timeFrame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
measure: Platelet Transfusions (Units), mITT Population
timeFrame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
measure: Platelet Transfusions, (Units), I-CABG PP Population
timeFrame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown/Emory School of Medicine
state: Georgia
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital Plano
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin, Inc.
state: Wisconsin
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton General Hospital, Hamilton Health Sciences Corporation
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital, Unity Health Toronto
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
state: Quebec
Study officials:
affiliation: Baylor Scott & White The Heart Hospital
name: Michael J Mack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School
name: C. M Gibson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton General Hospital
name: Richard Whitlock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.