← Back to Search

Device

Antithrombotic Removal using DrugSorb-ATR system for Bleeding and Hemorrhage (STAR-T Trial)

N/A
Waitlist Available
Led By Michael J Mack, MD
Research Sponsored by CytoSorbents, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female 18 years of age or older, with documented full, written informed consent
Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the first day post-operation
Awards & highlights

STAR-T Trial Summary

This trial will test a new system for removing ticagrelor during surgery. The system will be compared to the standard method for removal, and the trial will measure safety and effectiveness.

Eligible Conditions
  • Postoperative Hemorrhage
  • Hemorrhage
  • Blood Loss

STAR-T Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

STAR-T Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the first 48hrs post-operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and through the first 48hrs post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of peri-operative bleeding
Secondary outcome measures
Chest tube drainage
Incidence of fatal peri-operative bleeding
Incidence of moderate, severe, and massive peri-operative bleeding events
+6 more

STAR-T Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DrugSorb-ATR InterventionExperimental Treatment1 Intervention
Standard of care + DrugSorb-ATR system
Group II: ControlPlacebo Group1 Intervention
Standard of care with Sham set-up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DrugSorb-ATR system
2021
N/A
~140

Find a Location

Who is running the clinical trial?

CytoSorbents, IncLead Sponsor
16 Previous Clinical Trials
4,385 Total Patients Enrolled
2 Trials studying Postoperative Hemorrhage
509 Patients Enrolled for Postoperative Hemorrhage
Michael J Mack, MDPrincipal InvestigatorBaylor Scott & White The Heart Hospital
2 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Postoperative Hemorrhage
9 Patients Enrolled for Postoperative Hemorrhage
Richard Whitlock, MDPrincipal InvestigatorHamilton General Hospital
6 Previous Clinical Trials
32,519 Total Patients Enrolled

Media Library

DrugSorb-ATR system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04976530 — N/A
Postoperative Hemorrhage Research Study Groups: Control, DrugSorb-ATR Intervention
Postoperative Hemorrhage Clinical Trial 2023: DrugSorb-ATR system Highlights & Side Effects. Trial Name: NCT04976530 — N/A
DrugSorb-ATR system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04976530 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites in North America are administering this research protocol?

"A total of 36 medical sites are offering this study, such as Lutheran Medical Group in Fort Wayne, Advent Health in Orlando, and University of Mississippi in Jackson."

Answered by AI

How many participants are being recruited for this clinical trial?

"The clinical trial needs 120 compliant patients to be enrolled across multiple centres, including Lutheran Medical Group in Fort Wayne and Advent Health in Orlando. Those chosen must adhere to the inclusion criteria set forth by the study."

Answered by AI

Are there any eligible participants for this research endeavor at present?

"Affirmative. The information found on clinicaltrials.gov verifies that this examination is presently enrolling patients, which was first made available to the public on August 31st 2021 and last modified on November 17th 2022. 120 individuals have to be recruited from 36 distinct locations for the trial to commence."

Answered by AI
~40 spots leftby Mar 2025