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Antithrombotic Removal of Apixaban & Rivaroxaban for Bleeding (STAR-D 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 48 hours post-operation
Awards & highlights

STAR-D Trial Summary

This trial will test a new method to reduce the risk of serious bleeding in patients taking blood thinners who need urgent surgery.

Eligible Conditions
  • Postoperative Hemorrhage
  • Blood Loss
  • Hemorrhage

STAR-D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the first day post-operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and through the first day 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 perioperative bleeding
Secondary outcome measures
Chest tube drainage
DOAC drug removal: apixaban
DOAC drug removal: rivaroxaban
+7 more

STAR-D 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
4,516 Total Patients Enrolled
2 Trials studying Postoperative Hemorrhage
640 Patients Enrolled for Postoperative Hemorrhage
Michael J Mack, MDPrincipal InvestigatorBaylor Scott & White The Heart Hospital
2 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Postoperative Hemorrhage
140 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
140 Total Patients Enrolled
1 Trials studying Postoperative Hemorrhage
140 Patients Enrolled for Postoperative Hemorrhage

Media Library

DrugSorb-ATR system Clinical Trial Eligibility Overview. Trial Name: NCT05093504 — N/A
DrugSorb-ATR system 2023 Treatment Timeline for Medical Study. Trial Name: NCT05093504 — N/A
Postoperative Hemorrhage Patient Testimony for trial: Trial Name: NCT05093504 — N/A

Frequently Asked Questions

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

Is this clinical trial being conducted in numerous places across North America?

"This study is enrolling patients from 28 different sites, such as Bethesda North Hospital and TriHealth Inc. in Cincinnati. Additionally, the University of Colorado Denver and the University of Mississippi Jackson are also participating locations."

Answered by AI

Is enrollment in this clinical trial still available?

"The clinical trial in question, posted on December 27th 2021 and last modified on November 17th 2022, is not presently taking partakers. Nevertheless, there are 372 other medical studies that are currently recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California, Davis Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Since I have to thinners, I’d like to be able help somebody else if possible.
PatientReceived no prior treatments
~3 spots leftby Apr 2025