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

NCT04976530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-04-11

Study results available
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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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • CytoSorbents, Inc

    lead INDUSTRY

Principal Investigators

  • Michael J Mack, MD · Baylor Scott & White The Heart Hospital

  • C. M Gibson, MD · Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School

  • Richard Whitlock, MD · Hamilton General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2023-08-07
Completion
2023-08-07
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976530 on ClinicalTrials.gov