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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the first day post-operation
Awards & highlights

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

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

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
C. M Gibson, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Postoperative Hemorrhage
9 Patients Enrolled for Postoperative Hemorrhage

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
~35 spots leftby Sep 2025
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