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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the first day post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the first day post-operation
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 moreSTAR-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
Eligibility Criteria:
This trial includes the following eligibility criteria:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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