NCT05077124

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
6 countries

30 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

September 9, 2021

Last Update Submit

July 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

CytoSorbDEVICE

Sorbent hemoperfusion system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Use of CytoSorb for purpose other than antithrombotic removal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Universitätsklinikum Graz

Graz, Austria

RECRUITING

Medizinische Universität Innsbruck

Innsbruck, Austria

RECRUITING

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

Centre Hospitalier Universitaire de Liège

Liège, Belgium, Belgium

RECRUITING

OLV ziekenhuis Aalst VZW

Aalst, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, Belgium

RECRUITING

University Hospital Ghent

Ghent, Belgium

RECRUITING

Evangelisches Herzzentrum Coswig

Coswig, Germany

RECRUITING

Herzchirurgische Klinik Erlangen

Erlangen, Germany

RECRUITING

Universitätsklinikum Essen

Essen, Germany

RECRUITING

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Universitätsklinikum Heidelberg - Klinik für Herzchirurgie

Heidelberg, Germany

RECRUITING

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

Kiel, Germany

RECRUITING

Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig

Leipzig, Germany

RECRUITING

Artemed Klinikum München Süd GmbH & Co. KG

Munich, Germany

RECRUITING

LMU Klinikum Großhadern

Munich, Germany

RECRUITING

Deutsches Herzzentrum München

München, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, Germany

RECRUITING

Klinikum Oldenburg AöR

Oldenburg, Germany

RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, Germany

RECRUITING

Skåne University Hospital Lund

Lund, Sweden

RECRUITING

Hôpitaux Universitaires Genève

Geneva, Switzerland

RECRUITING

Stadtspital Zürich Clinic for Cardiac Surgery

Zurich, 8063, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, Switzerland

RECRUITING

Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital

Blackpool, United Kingdom

RECRUITING

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

London, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

RECRUITING

Related Publications (4)

  • 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: 38709456BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Blood Loss, SurgicalPostoperative Hemorrhage

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsPostoperative Complications

Study Officials

  • Michael Schmoeckel, Prof, MD

    LMU Klinikum Großhadern

    PRINCIPAL INVESTIGATOR
  • Robert Storey, Prof, BSc

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

October 14, 2021

Study Start

September 30, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations