Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent… (NCT04625764) | Clinical Trial Compass
TerminatedNot Applicable
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
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
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…