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Recruiting NCT05077124

Safe and Timely Antithrombotic Removal (STAR) Registry

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CytoSorb.
Who it may be relevant to
Registry conditions: Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, Germany, Sweden, Switzerland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Device CytoSorb
    Sorbent hemoperfusion system

Primary outcome measures

  • Bleeding complications including requirements for transfusions and other blood products [Time frame: Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 15 centers
  • Evangelisches Herzzentrum Coswig — Coswig
  • Herzchirurgische Klinik Erlangen — Erlangen
  • Universitätsklinikum Essen — Essen
  • Asklepios Kliniken Hamburg GmbH — Hamburg
  • Medizinische Hochschule Hannover — Hanover
  • Universitätsklinikum Heidelberg - Klinik für Herzchirurgie — Heidelberg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie — Kiel
  • Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig — Leipzig
  • … and 7 more centers
Austria · 4 centers
  • Universitätsklinikum Graz — Graz
  • Medizinische Universität Innsbruck — Innsbruck
  • Klinikum Klagenfurt am Wörthersee — Klagenfurt
  • Medical University of Vienna — Vienna
Belgium · 4 centers
  • Centre Hospitalier Universitaire de Liège — Liège
  • OLV ziekenhuis Aalst VZW — Aalst
  • Cliniques Universitaires Saint-Luc — Brussels
  • University Hospital Ghent — Ghent
Switzerland · 3 centers
  • Hôpitaux Universitaires Genève — Geneva
  • Stadtspital Zürich Clinic for Cardiac Surgery — Zurich
  • Universitätsspital Zürich — Zurich
United Kingdom · 3 centers
  • Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital — Blackpool
  • Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRU — London
  • Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
Sweden · 1 center
  • Skåne University Hospital Lund — Lund

Publications

  • 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 PMID 38709456
  • 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 PMID 40933270
  • 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 PMID 40044567
  • 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( PMID 39833891

Identifiers

NCT: NCT05077124 · O05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗