CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
DrugSorb-ATR system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04976530
NCT04976530N/ACompleted
CompareCT.gov

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

CytoSorbents, Inc·interventional·Posted Jul 26, 2021·Updated Apr 11, 2025

In Brief

A clinical study evaluating DrugSorb-ATR system and Sham comparator for Hemorrhage, Surgical and 3 related conditions. Completed, enrolled 140 participants across 29 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 26, 2021
Enrollment StartAug 31, 2021
Primary CompletionAug 7, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago

Interventions

DrugSorb-ATR systemdevice

Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit

Sham comparatordevice

Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit