NCT04976530

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: CytoSorbents, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhage, Surgical
• Blood Loss, Surgical
• Blood Loss, Postoperative
• Hemorrhage Postoperative

Interventions

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

Timeline

• Start date: 2021-08-31
• Primary completion: 2023-08-07
• Completion: 2023-08-07
• First posted: 2021-07-26
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study