Clinical trial NCT05077124: Safe and Timely Antithrombotic Removal (STAR) Registry
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemorrhage, Surgical
Hemorrhage Postoperative
Blood Loss, Surgical
Blood Loss, Postoperative
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

Eligibility 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

Primary outcomes:
measure: Bleeding complications including requirements for transfusions and other blood products
timeFrame: Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Aalst
country: Belgium
facility: OLV ziekenhuis Aalst VZW
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Coswig
country: Germany
facility: Evangelisches Herzzentrum Coswig
city: Erlangen
country: Germany
facility: Herzchirurgische Klinik Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig
city: Munich
country: Germany
facility: Artemed Klinikum München Süd GmbH & Co. KG
city: Munich
country: Germany
facility: LMU Klinikum Großhadern
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Lund
country: Sweden
facility: Skåne University Hospital Lund
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires Genève
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: LMU Klinikum Großhadern
name: Michael Schmoeckel, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sheffield
name: Robert Storey, Prof, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmoeckel M, Thielmann M, Hassan K, Geidel S, Schmitto J, Meyer AL, Vitanova K, Liebold A, Marczin N, Bernardi MH, Tandler R, Lindstedt S, Matejic-Spasic M, Wendt D, Deliargyris EN, Storey RF. Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry. J Thromb Thrombolysis. 2024 Aug;57(6):888-897. doi: 10.1007/s11239-024-02996-x. Epub 2024 May 6.