Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Blood sampling and analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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% 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB<br> | Procedure: Blood sampling and analysis<br>* Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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