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2021-01 START-Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): Prospective, Multi center, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor with the Intraoperative use of the DrugSorb-ATR

NCT04976530

START-Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): Prospective, Multi center, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor with the Intraoperative use of the DrugSorb-ATR Device in Patients Undergoing on-pump Cardiothoracic Surgery within Two Days of Ticagrelor Discontinuation

Associated Conditions

Structural Heart

Principal Investigator

Sponsor

CytoSorbents

This study is being conducted to assess the potential ability of a new method for removing drugs like ticagrelor from blood during heart or aortic surgery, using an adsorption (“sticky”) device called DrugSorb-ATR. Ticagrelor is a drug that is used to prevent blood cells from clumping together, and therefore decreases the ability of your blood cells to stop bleeding. The DrugSorb-ATR device may help remove ticagrelor from the blood, and in doing so, reduce the risk of serious bleeding caused by the drug during and after surgery. This device is investigational, which means it has not been approved by the FDA and its safety and effectiveness are unknown.

This study is currently enrolling.