Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)

CytoSorbents

Status: Terminated

Conditions: Blood Loss, Postoperative; Blood Loss, Surgical; Hemorrhage, Surgical; Hemorrhage Postoperative

Treatments: Device: DrugSorb-ATR system; Device: Sham comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05093504

2021-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups

Control

Sham Comparator group

Description:

Standard of care with Sham set-up

Treatment:

Device: Sham comparator

DrugSorb-ATR Intervention

Experimental group

Description:

Standard of care + DrugSorb-ATR system

Treatment:

Device: DrugSorb-ATR system