Registry for safe removal of blood thinners using CytoSorb
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 study is testing if a device called CytoSorb can safely help remove blood thinners from patients who are at risk of bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CytoSorbents, Inc Industry-sponsored |
| Locations | 30 sites (Graz and 29 other locations) |
| Trial ID | NCT05077124 on ClinicalTrials.gov |
What this trial studies
The STAR Registry aims to collect real-world clinical data on the use of CytoSorb for the removal of antithrombotic agents in patients at risk of bleeding. This observational registry will include both retrospective and prospective patient data to assess clinical outcomes and usage patterns. The focus is on understanding the safety and effectiveness of CytoSorb in mitigating bleeding risks associated with antithrombotic medications. Data will be collected for up to 30 days post-operation to evaluate any device-related adverse events.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients undergoing surgical procedures who require antithrombotic removal using CytoSorb.
Not a fit: Patients using CytoSorb for purposes other than antithrombotic removal will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve patient safety by providing insights into effective management of bleeding risks associated with antithrombotic therapy.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in managing bleeding risks with antithrombotic agents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CytoSorb utilization for antithrombotic removal * Informed consent for prospective registry participation Exclusion Criteria: • Use of CytoSorb for purpose other than antithrombotic removal
Where this trial is running
Graz and 29 other locations
- Universitätsklinikum Graz — Graz, Austria (Recruiting)
- Medizinische Universität Innsbruck — Innsbruck, Austria (Recruiting)
- Klinikum Klagenfurt am Wörthersee — Klagenfurt, Austria (Recruiting)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- Centre Hospitalier Universitaire de Liège — Liège, Belgium, Belgium (Recruiting)
- OLV ziekenhuis Aalst VZW — Aalst, Belgium (Recruiting)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (Recruiting)
- University Hospital Ghent — Ghent, Belgium (Recruiting)
- Evangelisches Herzzentrum Coswig — Coswig, Germany (Recruiting)
- Herzchirurgische Klinik Erlangen — Erlangen, Germany (Recruiting)
- Universitätsklinikum Essen — Essen, Germany (Recruiting)
- Asklepios Kliniken Hamburg GmbH — Hamburg, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hanover, Germany (Recruiting)
- Universitätsklinikum Heidelberg - Klinik für Herzchirurgie — Heidelberg, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie — Kiel, Germany (Recruiting)
- Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig — Leipzig, Germany (Recruiting)
- Artemed Klinikum München Süd GmbH & Co. KG — Munich, Germany (Recruiting)
- LMU Klinikum Großhadern — Munich, Germany (Recruiting)
- Deutsches Herzzentrum München — München, Germany (Recruiting)
- Klinikum Nürnberg — Nuremberg, Germany (Recruiting)
- Klinikum Oldenburg AöR — Oldenburg, Germany (Recruiting)
- Krankenhaus der Barmherzigen Brüder Trier — Trier, Germany (Recruiting)
- Universitätsklinikum Ulm — Ulm, Germany (Recruiting)
- Skåne University Hospital Lund — Lund, Sweden (Recruiting)
- Hôpitaux Universitaires Genève — Geneva, Switzerland (Recruiting)
- Stadtspital Zürich Clinic for Cardiac Surgery — Zurich, Switzerland (Recruiting)
- Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
- Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital — Blackpool, United Kingdom (Recruiting)
- Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST) — London, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Michael Schmoeckel, Prof, MD — LMU Klinikum Großhadern
- Study coordinator: Cindy Rechner, PhD
- Email: star@cytosorbents.com
- Phone: +49 30 654 99 145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.