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

CytoSorbents

Status

Terminated

Conditions

Acute Coronary Syndrome

Treatments

Procedure: Blood sampling and analysis

Study type

Interventional

Funder types

Industry

Identifiers

NCT04625764

CSI17

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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