Safe and Timely Antithrombotic Removal (STAR) Registry

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077124
• Other study ID #: O05
• Status: Recruiting
• Start date: September 30, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: CytoSorbents, Inc
• Contact: Cindy Rechner, PhD
• Phone: +49 30 654 99 145
• Email: star[@]cytosorbents.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CytoSorb utilization for antithrombotic removal

• Informed consent for prospective registry participation

Exclusion Criteria:

• Use of CytoSorb for purpose other than antithrombotic removal

Related Conditions & MeSH terms

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

Intervention

Device:
• CytoSorb
Sorbent hemoperfusion system

Locations

Country	Name	City	State
Austria	Universitätsklinikum Graz	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt
Austria	Medical University of Vienna	Vienna
Belgium	OLV ziekenhuis Aalst VZW	Aalst
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	University Hospital Ghent	Ghent
Germany	MediClin Herzzentrum Coswig	Coswig
Germany	Herzchirurgische Klinik Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Asklepios Kliniken Hamburg GmbH	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg - Klinik für Herzchirurgie	Heidelberg
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie	Kiel
Germany	Deutsches Herzzentrum Mu¨nchen	München
Germany	Artemed Klinikum München Süd GmbH & Co. KG	Munich
Germany	LMU Klinikum Großhadern	Munich
Germany	Klinikum Nürnberg	Nürnberg
Germany	Klinikum Oldenburg AöR	Oldenburg
Germany	Krankenhaus der Barmherzigen Brüder Trier	Trier
Germany	Universitätsklinikum Ulm	Ulm
Sweden	Skåne University Hospital Lund	Lund
United Kingdom	Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents, Inc

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding complications including requirements for transfusions and other blood products		Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days