Safe and Timely Antithrombotic Removal (STAR) Registry

Recruiting

• Conditions: Blood Loss, Surgical; Blood Loss, Postoperative; Hemorrhage, Surgical; Hemorrhage Postoperative

• Registration Number: NCT05077124
• Lead Sponsor: CytoSorbents, Inc

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-09
• Study Start: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

• Use of CytoSorb for purpose other than antithrombotic removal

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

Universitätsklinikum Graz; 🇦🇹 Graz, Austria

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

OLV ziekenhuis Aalst VZW; 🇧🇪 Aalst, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Evangelisches 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

Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig; 🇩🇪 Leipzig, Germany

Artemed Klinikum München Süd GmbH & Co. KG; 🇩🇪 Munich, Germany

LMU Klinikum Großhadern; 🇩🇪 Munich, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Klinikum Oldenburg AöR; 🇩🇪 Oldenburg, Germany

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Skåne University Hospital Lund; 🇸🇪 Lund, Sweden

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, United Kingdom