Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)

CytoSorbents

Status: Completed

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

NCT04976530

2021-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 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