Actively Recruiting

Age: 18Years +
All Genders
ID05077124

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

Led by CytoSorbents, Inc · Updated on 2025-07-16

1000

Participants Needed

30

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting real-world data on how the CytoSorb device is used to remove antithrombotic agents in hospital patients. The registry aims to understand clinical use patterns and related outcomes, particularly focusing on reducing bleeding risks linked to these medications. Both past and current patient data will be included to provide comprehensive insights. The study involves gathering clinical information on patients who receive CytoSorb treatment specifically for antithrombotic removal during acute hospital care. CytoSorb is a sorbent hemoperfusion device used to filter out these agents. The registry includes both retrospective and prospective data collection, with safety monitored by tracking any device-related adverse events. Participants’ clinical outcomes will be followed for up to 30 days after their procedure. Key measurements include bleeding complications and the need for blood transfusions or other blood products, assessed until postoperative day 3, ICU discharge, or death, whichever occurs first. This observational registry does not involve experimental treatments but records standard care outcomes to better understand the device's use and safety.

CONDITIONS

Brief Title

Safe and Timely Antithrombotic Removal (STAR) Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • CytoSorb utilization for antithrombotic removal
  • Informed consent for prospective registry participation
Not Eligible

You will not qualify if you...

  • Use of CytoSorb for purpose other than antithrombotic removal

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to the day of the operation

Participants undergo antithrombotic removal using the CytoSorb device during their acute hospital care.

1 procedure visit

Post-operative Follow-up

Duration - Up to 30 days post-operation

Participants are monitored for safety and clinical outcomes related to antithrombotic removal, including bleeding complications.

Up to 30 days of follow-up visits

Trial Site Locations

Total: 30 locations

1

Universitätsklinikum Graz

Graz, Austria

Actively Recruiting

2

Medizinische Universität Innsbruck

Innsbruck, Austria

Actively Recruiting

3

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Actively Recruiting

4

Medical University of Vienna

Vienna, Austria

Actively Recruiting

5

Centre Hospitalier Universitaire de Liège

Liège, Belgium, Belgium

Actively Recruiting

6

OLV ziekenhuis Aalst VZW

Aalst, Belgium

Actively Recruiting

7

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Actively Recruiting

8

University Hospital Ghent

Ghent, Belgium

Actively Recruiting

9

Evangelisches Herzzentrum Coswig

Coswig, Germany

Actively Recruiting

10

Herzchirurgische Klinik Erlangen

Erlangen, Germany

Actively Recruiting

11

Universitätsklinikum Essen

Essen, Germany

Actively Recruiting

12

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Actively Recruiting

13

Medizinische Hochschule Hannover

Hanover, Germany

Actively Recruiting

14

Universitätsklinikum Heidelberg - Klinik für Herzchirurgie

Heidelberg, Germany

Actively Recruiting

15

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie

Kiel, Germany

Actively Recruiting

16

Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig

Leipzig, Germany

Actively Recruiting

17

Artemed Klinikum München Süd GmbH & Co. KG

Munich, Germany

Actively Recruiting

18

LMU Klinikum Großhadern

Munich, Germany

Actively Recruiting

19

Deutsches Herzzentrum München

München, Germany

Actively Recruiting

20

Klinikum Nürnberg

Nuremberg, Germany

Actively Recruiting

21

Klinikum Oldenburg AöR

Oldenburg, Germany

Actively Recruiting

22

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Actively Recruiting

23

Universitätsklinikum Ulm

Ulm, Germany

Actively Recruiting

24

Skåne University Hospital Lund

Lund, Sweden

Actively Recruiting

25

Hôpitaux Universitaires Genève

Geneva, Switzerland

Actively Recruiting

26

Stadtspital Zürich Clinic for Cardiac Surgery

Zurich, Switzerland, 8063

Actively Recruiting

27

Universitätsspital Zürich

Zurich, Switzerland

Actively Recruiting

28

Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital

Blackpool, United Kingdom

Actively Recruiting

29

Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)

London, United Kingdom

Actively Recruiting

30

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Actively Recruiting

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Research Team

C

Cindy Rechner, PhD

R

Robert Wilke

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry.

Michael Schmoeckel, Matthias Thielmann, Kambiz Hassan...

https://pubmed.ncbi.nlm.nih.gov/38709456

Intraoperative antithrombotic drug removal during heart transplantation: A case series from the International Safe and Timely Antithrombotic Removal (STAR) registry.

Jan Schmitto, Filip De Somer, Matthias Thielmann...

https://pubmed.ncbi.nlm.nih.gov/40933270

Early CABG with intraoperative hemoadsorption in patients on ticagrelor: Real-world data from the international Safe and Timely Antithrombotic Removal (STAR) registry.

Robert F Storey, Kambiz Hassan, Anna L Meyer...

https://pubmed.ncbi.nlm.nih.gov/40044567

Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry.

Michael Schmoeckel, Matthias Thielmann, Keti Vitanova...

https://pubmed.ncbi.nlm.nih.gov/39833891