Safe and Timely Antithrombotic Removal (STAR) Registry

NCT05077124 — Active not recruiting, 1000 participants, CytoSorbents, Inc
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Safe and Timely Antithrombotic Removal (STAR) Registry: International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting

RegistryNCT05077124
StatusActive not recruiting
Study typeObservational
Enrollment1000 (Estimated)
SponsorCytoSorbents, Inc (Industry)
ConditionsHemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
InterventionsCytoSorb (Device)
Datesstart 2021-09-30, primary completion 2030-09-30 (estimated), completion 2030-09-30 (estimated), first posted 2021-10-14, last updated 2026-10-21
Locations29 sites in Austria, Belgium, Germany, Sweden, Switzerland, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Hemorrhage, Surgical All trials for Hemorrhage Postoperative All trials of CytoSorb

-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.

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+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.

+Arms and interventions

  • CytoSorb (Device): Sorbent hemoperfusion system

+Outcome measures

Primary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

• Use of CytoSorb for purpose other than antithrombotic removal

+Locations (29)

FacilityCityCountryStatus
Universitätsklinikum GrazGrazAustria
Medizinische Universität InnsbruckInnsbruckAustria
Medical University of ViennaViennaAustria
Centre Hospitalier Universitaire de LiègeLiège, BelgiumBelgium
OLV ziekenhuis Aalst VZWAalstBelgium
Cliniques Universitaires Saint-LucBrusselsBelgium
University Hospital GhentGhentBelgium
Evangelisches Herzzentrum CoswigCoswigGermany
Herzchirurgische Klinik ErlangenErlangenGermany
Universitätsklinikum EssenEssenGermany
Asklepios Kliniken Hamburg GmbHHamburgGermany
Medizinische Hochschule HannoverHanoverGermany
Universitätsklinikum Heidelberg - Klinik für HerzchirurgieHeidelbergGermany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und GefäßchirurgieKielGermany
Herzzentrum Leipzig and Helios Health Institute GmbH LeipzigLeipzigGermany
Artemed Klinikum München Süd GmbH & Co. KGMunichGermany
LMU Klinikum GroßhadernMunichGermany
Deutsches Herzzentrum MünchenMünchenGermany
Klinikum NürnbergNurembergGermany
Klinikum Oldenburg AöROldenburgGermany
Krankenhaus der Barmherzigen Brüder TrierTrierGermany
Universitätsklinikum UlmUlmGermany
Skåne University Hospital LundLundSweden
Hôpitaux Universitaires GenèveGenevaSwitzerland
Stadtspital Zürich Clinic for Cardiac SurgeryZurichSwitzerland
Universitätsspital ZürichZurichSwitzerland
Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria HospitalBlackpoolUnited Kingdom
Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)LondonUnited Kingdom
Sheffield Teaching Hospitals NHS Foundation TrustSheffieldUnited Kingdom

+Publications

  • Results publication: 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. PMID 38709456
  • Results publication: 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. PMID 40933270
  • Results publication: 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. 2026 Jan;82:50-56. doi: 10.1016/j.carrev.2025.02.015. Epub 2025 Feb 28. PMID 40044567
  • Results publication: 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. PMID 39833891

+Investigators