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Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)

NCT05093504 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-05-04

Study results available
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Summary

Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery

Conditions

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

Interventions

DEVICE

Sham comparator

Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit

DEVICE

DrugSorb-ATR system

Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2024-01-29
Completion
2024-01-29
FDA Device
Yes

Countries

  • United States

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 NCT05093504 on ClinicalTrials.gov