Safe and Timely Antithrombotic Removal (STAR) Registry

NCT ID: NCT05077124

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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CytoSorb

Sorbent hemoperfusion system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Use of CytoSorb for purpose other than antithrombotic removal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytoSorbents, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Schmoeckel, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

LMU Klinikum Großhadern

Robert Storey, Prof, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

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Universitätsklinikum Graz

Graz, , Austria

Site Status RECRUITING

Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Site Status RECRUITING

Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Centre Hospitalier Universitaire de Liège

Liège, Belgium, Belgium

Site Status RECRUITING

OLV ziekenhuis Aalst VZW

Aalst, , Belgium

Site Status RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

University Hospital Ghent

Ghent, , Belgium

Site Status RECRUITING

Evangelisches Herzzentrum Coswig

Coswig, , Germany

Site Status RECRUITING

Herzchirurgische Klinik Erlangen

Erlangen, , Germany

Site Status RECRUITING

Universitätsklinikum Essen

Essen, , Germany

Site Status RECRUITING

Asklepios Kliniken Hamburg GmbH

Hamburg, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg - Klinik für Herzchirurgie

Heidelberg, , Germany

Site Status RECRUITING

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

Kiel, , Germany

Site Status RECRUITING

Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig

Leipzig, , Germany

Site Status RECRUITING

Artemed Klinikum München Süd GmbH & Co. KG

Munich, , Germany

Site Status RECRUITING

LMU Klinikum Großhadern

Munich, , Germany

Site Status RECRUITING

Deutsches Herzzentrum München

München, , Germany

Site Status RECRUITING

Klinikum Nürnberg

Nuremberg, , Germany

Site Status RECRUITING

Klinikum Oldenburg AöR

Oldenburg, , Germany

Site Status RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Skåne University Hospital Lund

Lund, , Sweden

Site Status RECRUITING

Hôpitaux Universitaires Genève

Geneva, , Switzerland

Site Status RECRUITING

Stadtspital Zürich Clinic for Cardiac Surgery

Zurich, , Switzerland

Site Status RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital

Blackpool, , United Kingdom

Site Status RECRUITING

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

London, , United Kingdom

Site Status RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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Austria Belgium Germany Sweden Switzerland United Kingdom

Central Contacts

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Cindy Rechner, PhD

Role: CONTACT

+49 30 654 99 145

Robert Wilke

Role: CONTACT

+49 30 654 99 145

References

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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.

Reference Type BACKGROUND
PMID: 38709456 (View on PubMed)

Schmitto J, De Somer F, Thielmann M, Marczin N, Ruhparwar A, Meyer AL, Hagl C, Matejic-Spasic M, Wendt D, Fan W, Deliargyris EN, Storey RF, Schmoeckel M. Intraoperative antithrombotic drug removal during heart transplantation: A case series from the International Safe and Timely Antithrombotic Removal (STAR) registry. JHLT Open. 2025 Aug 20;10:100369. doi: 10.1016/j.jhlto.2025.100369. eCollection 2025 Nov.

Reference Type DERIVED
PMID: 40933270 (View on PubMed)

Storey RF, Hassan K, Meyer AL, Eberle T, deNeve N, Thielmann M, Bernardi MH, Marczin N, Guenther U, Panholzer B, Maechler H, Hunter S, Matejic-Spasic M, Wendt D, Deliargyris EN, Schmoeckel M. Early CABG with intraoperative hemoadsorption in patients on ticagrelor: Real world data from the international Safe and Timely Antithrombotic Removal (STAR) registry. Cardiovasc Revasc Med. 2025 Feb 28:S1553-8389(25)00065-X. doi: 10.1016/j.carrev.2025.02.015. Online ahead of print.

Reference Type DERIVED
PMID: 40044567 (View on PubMed)

Schmoeckel M, Thielmann M, Vitanova K, Eberle T, Marczin N, Hassan K, Liebold A, Lindstedt S, Machler G, Matejic-Spasic M, Wendt D, Deliargyris EN, Storey RF. 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. J Cardiothorac Surg. 2025 Jan 20;20(1):74. doi: 10.1186/s13019-024-03326-1.

Reference Type DERIVED
PMID: 39833891 (View on PubMed)

Other Identifiers

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O05

Identifier Type: -

Identifier Source: org_study_id

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