Clinical trial NCT04625764: Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndrome
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
Lead sponsor: CytoSorbents Europe GmbH
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Platelet reactivity
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
city: Hamburg
country: Germany
facility: Asklepios Hospital St. Georg Hamburg
city: Jena
country: Germany
facility: University Hospital Jena
city: Luxembourg
country: Luxembourg
facility: Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle
Study officials:
affiliation: Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany
name: Kambiz Hassan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: