Clinical trial NCT05093504: Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Official title: Safe & Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D): Prospective, Multicenter, Double-blind, Randomized Study of Apixaban & Rivaroxaban Removal to Reduce Risk of Serious Bleeding in Urgent Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemorrhage, Surgical
Hemorrhage Postoperative
Blood Loss, Surgical
Blood Loss, Postoperative
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 9
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, 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 18 years or older, with documented full, written informed consent
2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (\*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)

Exclusion Criteria:

1. \>48hrs between last apixaban or rivaroxaban dose and start of CT surgery
2. Patients on low dose apixaban or rivaroxaban for prophylactic indications
3. Heart-lung transplant procedures
4. Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device \[LVAD\] or right ventricular assist device \[RVAD\])
5. Any of the below conditions that pose a known risk for increased bleeding

   1. Heparin induced thrombocytopenia
   2. Preoperative platelet count \<50,000u/L
   3. Hemophilia
   4. International normalized ratio (INR) greater than or equal to 1.8
6. Prohibited concomitant antithrombotic medications as defined in the study protocol
7. Acute sickle cell crisis
8. Known allergy to device components
9. Active (untreated) systemic infection
10. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
11. Women with positive pregnancy test during current admission or who are breast-feeding
12. Life expectancy \<30 days
13. Inability to comply with requirements of the study protocol
14. Treatment with investigational drug or device within 30 days of current surgery
15. Previous enrollment in this trial

Primary outcomes:
measure: Incidence of Perioperative Bleeding
timeFrame: Through the first 48 hours post-operation
Secondary outcomes:
measure: Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban
timeFrame: Through 30 minutes post-CPB
measure: Chest Tube Drainage
timeFrame: Through 24 hours post-operation
measure: Platelet Transfusions (Volume)
timeFrame: Through to discharge from index hospitalization, on average 1-2 weeks
measure: Platelet Transfusions (Units)
timeFrame: Through to discharge from index hospitalization, on average 1-2 weeks
measure: Packed Red Blood Cell (PRBC) Transfusions (Volume)
timeFrame: Through to discharge from index hospitalization, on average 1-2 weeks
measure: PRBC Transfusions (Units)
timeFrame: Through to discharge from index hospitalization, on average 1-2 weeks
measure: Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events
timeFrame: Through the first day post-operation
measure: Surgical Re-exploration for Bleeding
timeFrame: Through to discharge from index hospitalization, on average 1-2 weeks
measure: Incidence of Fatal Perioperative Bleeding
timeFrame: 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: Denver
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
state: Florida
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown/Emory School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
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: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
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: NYU Langone Medical Center
state: New York
city: Cincinnati
country: United States
facility: Bethesda North Hospital, TriHealth, Inc
state: Ohio
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
state: Texas
city: Richmond
country: United States
facility: VCU Medical Center
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
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
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.