Safe and Timely Antithrombotic Removal (STAR) Registry

July 15, 2025 updated by: CytoSorbents, Inc

Safe and Timely Antithrombotic Removal (STAR) Registry: International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting

This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb. The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent. This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb. Data of retrospective and prospective patients will be included in the registry. Safety will be assessed by collection of (at least possibly) device-related adverse events. Data collection is done up to 30 days post-operation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Universitätsklinikum Graz
        • Principal Investigator:
          • Christian Mayer, MD
      • Innsbruck, Austria
        • Recruiting
        • Medizinische Universität Innsbruck
        • Principal Investigator:
          • Judith Martini, Univ.-Prof., PD, MD
      • Klagenfurt, Austria
        • Recruiting
        • Klinikum Klagenfurt am Wörthersee
        • Principal Investigator:
          • Markus Köstenberger, MD
      • Vienna, Austria
        • Recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Martin Bernardi, ap. Prof. PD Dr. Dr.
  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLV ziekenhuis Aalst VZW
        • Principal Investigator:
          • Nikolaas De Neve, MD
      • Bruxelles, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Robert Tircoveanu, MD
      • Ghent, Belgium
        • Recruiting
        • University Hospital Ghent
        • Principal Investigator:
          • Filip de Somer, Prof, PhD
      • Liège, Belgium
        • Recruiting
        • Centre Hospitalier Universitaire de Liège
        • Principal Investigator:
          • Manuel Azevedo Mendes, MD
  • Germany
      • Coswig, Germany
        • Recruiting
        • Evangelisches Herzzentrum Coswig
        • Principal Investigator:
          • Thomas Eberle, MD
      • Erlangen, Germany
        • Recruiting
        • Herzchirurgische Klinik Erlangen
        • Principal Investigator:
          • Mathieu Suleiman, MD
      • Essen, Germany
        • Recruiting
        • Universitätsklinikum Essen
        • Principal Investigator:
          • Matthias Thielmann, Prof, MD
      • Hamburg, Germany
        • Recruiting
        • Asklepios Kliniken Hamburg GmbH
        • Principal Investigator:
          • Kambiz Hassan, MD
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Jan Schmitto, Prof, MD
      • Heidelberg, Germany
        • Recruiting
        • Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
        • Principal Investigator:
          • Anna L. Meyer, Prof, MD
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie
        • Principal Investigator:
          • Bernd Panholzer, MD
      • Leipzig, Germany
        • Recruiting
        • Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig
        • Principal Investigator:
          • Michael Höbartner, MD
      • Munich, Germany
        • Recruiting
        • LMU Klinikum Großhadern
        • Principal Investigator:
          • Michael Schmoeckel, Prof, MD
      • Munich, Germany
        • Recruiting
        • Artemed Klinikum München Süd GmbH & Co. KG
        • Principal Investigator:
          • Helmut Mair, MD
      • München, Germany
        • Recruiting
        • Deutsches Herzzentrum München
        • Principal Investigator:
          • Keti Vitanova, PD, MD
      • Nürnberg, Germany
        • Recruiting
        • Klinikum Nürnberg
        • Principal Investigator:
          • Spela Leiler, MD
      • Oldenburg, Germany
        • Recruiting
        • Klinikum Oldenburg AöR
        • Principal Investigator:
          • Mareike Diekmann, MD
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Bruder Trier
        • Principal Investigator:
          • Terrence John Donovan, MD
      • Ulm, Germany
        • Recruiting
        • Universitatsklinikum Ulm
        • Principal Investigator:
          • Andreas Liebold, Prof, MD
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Skane University Hospital Lund
        • Principal Investigator:
          • Sandra Lindstedt, MD, PhD
  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • Hôpitaux Universitaires Genève
        • Principal Investigator:
          • Vitor Nogueira Mendes
      • Zürich, Switzerland
        • Recruiting
        • UniversitätsSpital Zürich
        • Principal Investigator:
          • Hector Rodriguez Cetina Biefer, PD, MD
      • Zürich, Switzerland, 8063
        • Recruiting
        • Stadtspital Zürich Clinic for Cardiac Surgery
        • Principal Investigator:
          • Omer Dzemali, Prof., MD, Dr. h.c.
  • United Kingdom
      • Blackpool, United Kingdom
        • Recruiting
        • Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital
        • Principal Investigator:
          • Yvonne Ashworth
      • London, United Kingdom
        • Recruiting
        • Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)
        • Principal Investigator:
          • Nandor Marczin, MD
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Steven Hunter, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing invasive management, including surgery, who receive CytoSorb therapy for antithrombotic removal as part of their routine clinical care can be included in this registry

Description

Inclusion Criteria:

  • CytoSorb utilization for antithrombotic removal
  • Informed consent for prospective registry participation

Exclusion Criteria:

• Use of CytoSorb for purpose other than antithrombotic removal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Bleeding complications including requirements for transfusions and other blood products
Time Frame: Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CytoSorbents, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Storey, Prof, BSc, University of Sheffield
  • Principal Investigator: Michael Schmoeckel, Prof, MD, LMU Klinikum Großhadern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • O05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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