Hemorrhage, SurgicalNCT05077124
Safe and Timely Antithrombotic Removal (STAR) Registry
An observational study of Hemorrhage, Surgical and Hemorrhage Postoperative, run by CytoSorbents, Inc at 29 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 30 Sep 2021to 30 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- CytoSorb utilization for antithrombotic removal
- Informed consent for prospective registry participation
Who cannot join
- Use of CytoSorb for purpose other than antithrombotic removal
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
Germany15 sites
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
Deutsches Herzzentrum München
München
Artemed Klinikum München Süd GmbH & Co. KG
Munich
LMU Klinikum Großhadern
Munich
Klinikum Nürnberg
Nuremberg
Klinikum Oldenburg AöR
Oldenburg
Krankenhaus der Barmherzigen Brüder Trier
Trier
Universitätsklinikum Ulm
Ulm
Belgium4 sites
OLV ziekenhuis Aalst VZW
Aalst
Cliniques Universitaires Saint-Luc
Brussels
University Hospital Ghent
Ghent
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Austria3 sites
Universitätsklinikum Graz
Graz
Medizinische Universität Innsbruck
Innsbruck
Medical University of Vienna
Vienna
Switzerland3 sites
Hôpitaux Universitaires Genève
Geneva
Stadtspital Zürich Clinic for Cardiac Surgery
Zurich, 8063
Universitätsspital Zürich
Zurich
United Kingdom3 sites
Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital
Blackpool
Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)
London
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
About this study
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
This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.
Read the 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.
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Being tested
- CytoSorb
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Sorbent hemoperfusion system
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding complications including requirements for transfusions and other blood products
Measured: Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start30 Sep 2021
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Schmoeckel, Prof, MD, Principal investigator, LMU Klinikum GroßhadernUwe Zeymer, Prof, MD, Principal investigator, Klinikum Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077124
- Sponsor's protocol ID
- O05
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Aug;57(6):888-897. doi: 10.1007/s11239-024-02996-x. Epub 2024 May 6.
PubMed 38709456Schmitto 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.
PubMed 40933270Storey 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.
PubMed 40044567Schmoeckel 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.
PubMed 39833891
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05077124
- Acronym / sponsor ID
- O05
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- CytoSorb utilization for antithrombotic removal
- Informed consent for prospective registry participation
Key exclusion criteria (1 listed)
- Use of CytoSorb for purpose other than antithrombotic removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorbSorbent hemoperfusion system | Device | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Results publication: PubMed 38709456Schmoeckel 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.
- Derived from this study: PubMed 40933270Schmitto 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.
- Derived from this study: PubMed 40044567Storey 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.
- Derived from this study: PubMed 39833891Schmoeckel 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.
- Individual participant dataSharing planned: No
Related trials for Hemorrhage, Surgical
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma
Spinal Epidural Hematoma
Not yet recruitingObservational study
Effect of Methotrexate on Blood Loss During Laparoscopic Management of CS Scar Pregnancy
Cesarean Scar Pregnancy
Recruiting
TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schmoeckel, Prof, MD principal investigator
LMU Klinikum Großhadern
Uwe Zeymer, Prof, MD principal investigator
Klinikum Ludwigshafen
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, Surgical and Hemorrhage Postoperative, run by CytoSorbents, Inc at 29 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Belgium, Austria, Switzerland, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077124, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.