Acute Coronary SyndromeCyTationNCT04625764
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
A study testing Blood sampling and analysis in people with Acute Coronary Syndrome, run by CytoSorbents Europe GmbH at 4 sites in 2 countries.
Trial summary
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Blood sampling and analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Feb 2021to 14 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Signed informed consent
- Males and females aged ≥18 years
- Patients treated with ticagrelor
- Emergency Coronary Artery Bypass Graft (CABG) surgery
- Cardiothoracic surgery requiring CPB ≤24 hours following the last dose of ticagrelor
Who cannot join
- Any cardiothoracic surgery >24 hours after last dose of ticagrelor
- Resuscitation
- Any pre-operative coagulopathy unrelated to ticagrelor or standard of care (SoC) to undergo surgery with CPB
- Sepsis (according to Sepsis 3.0 definition)
- Malignant tumor
- Left ventricular ejection fraction (LVEF) < 20%
Show all 12Show fewer
- History or presence of significant pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurologic, or psychiatric disease which, in the opinion of the Investigator, increases risk to the patient or could confound the results of the study
- Presence of end-stage renal disease or currently receiving renal replacement therapy
- Patients with a history of major organ transplantation
- Patients in acute sickle cell crisis
- Patients concurrently requiring immunosuppressive therapy, with the exception of corticosteroids, or who are profoundly immune suppressed (e.g. CD4 < 200 or neutropenia with ANC < 1000/μL)
- Women of childbearing potential with a positive pregnancy test performed during the current admission or who are lactating. Women are considered not of child bearing potential if they have been sterilized at least 6 months prior to the study or if they are post-menopausal, defined as amenorrhea for at least 12 months
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
University Hospital Essen
Essen, 45147
Asklepios Hospital St. Georg Hamburg
Hamburg, 20099
University Hospital Jena
Jena, 07747
Luxembourg1 site
Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle
Luxembourg, 1210
About this study
Official title: A Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Blood sampling and analysis
- Keywords
- Cardiopulmonary bypass, CPB, Ticagrelor removal, CytoSorb, Platelet reactivity, MEA platform test, Intensive care medicine, Hemadsorbtion, Extracorporeal blood purification, Coronary Artery Bypass Grafting, CABG, Cardiac Surgery, Aortic valve replacement, Mitral valve replacement
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and analysisProcedure or surgery
Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)
| Study group | Role | What they receive |
|---|---|---|
| patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB | Experimental | Not described Receives: Procedure: Blood sampling and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Proportion of patients with post-operative platelet reactivity to ADP above the level associated with increased bleeding risk (≥ 22 ADP-induced platelet aggregation units (AUC in units)) measured on the MEA platform immediately after CPB compared to immediately before CPB.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start23 Feb 2021
- Primary completion14 Oct 2021
- Study completion14 Dec 2021
Why it stopped: Due to Corona pandemic, planned ammount of enrolled patient could not be reached, protocol section "Early termination of the study" - criterion "Difficulties in recruiting patients" is fully met-\>recruitment period will not be extended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kambiz Hassan, M.D., Principal investigator, Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625764
- Sponsor's protocol ID
- CSI17
- Acronym
- CyTation
- Status last verified
- Jan 2022
- First submitted
- 6 Nov 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT04625764
- Acronym / sponsor ID
- CyTation / CSI17
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiopulmonary bypass, CPB, Ticagrelor removal, CytoSorb, Platelet reactivity, MEA platform test, Intensive care medicine, Hemadsorbtion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Corona pandemic, planned ammount of enrolled patient could not be reached, protocol section "Early termination of the study" - criterion "Difficulties in recruiting patients" is fully met-\>recruitment period will not be extended
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CytoSorbents Europe GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 12 Nov 2020 (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.
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB | Experimental | Procedure: Blood sampling and analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Males and females aged ≥18 years
- Patients treated with ticagrelor
- Emergency Coronary Artery Bypass Graft (CABG) surgery
- Cardiothoracic surgery requiring CPB ≤24 hours following the last dose of ticagrelor
Key exclusion criteria (12 listed)
- Any cardiothoracic surgery >24 hours after last dose of ticagrelor
- Resuscitation
- Any pre-operative coagulopathy unrelated to ticagrelor or standard of care (SoC) to undergo surgery with CPB
- Sepsis (according to Sepsis 3.0 definition)
- Malignant tumor
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 |
|---|---|---|
| Blood sampling and analysisBlood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest) | Procedure or surgery | patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB |
Primary outcome
Platelet reactivity
Time frame: 8 hours
Proportion of patients with post-operative platelet reactivity to ADP above the level associated with increased bleeding risk (≥ 22 ADP-induced platelet aggregation units (AUC in units)) measured on the MEA platform immediately after CPB compared to immediately before CPB.
Results and safety
The study was stopped early (reason given: Due to Corona pandemic, planned ammount of enrolled patient could not be reached, protocol section "Early termination of the study" - criterion "Difficulties in recruiting patients" is fully met-\>recruitment period will not be extended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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.
Kambiz Hassan, M.D. principal investigator
Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and analysis in people with Acute Coronary Syndrome, run by CytoSorbents Europe GmbH at 4 sites in 2 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Luxembourg. 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?
The study was stopped early (reason given: Due to Corona pandemic, planned ammount of enrolled patient could not be reached, protocol section "Early termination of the study" - criterion "Difficulties in recruiting patients" is fully met-\>recruitment period will not be extended). Results are not available in the source record.
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?
Platelet reactivity (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2022.