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

Acute Coronary Syndrome Clinical Trial

— CyTation  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04625764
• Other study ID #: CSI17
• Status: Terminated
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: December 14, 2021

Study information

• Verified date: January 2022
• Source: CytoSorbents Europe GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Procedure:
• Blood sampling and analysis
Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen
Germany	Asklepios Hospital St. Georg Hamburg	Hamburg
Germany	University Hospital Jena	Jena
Luxembourg	Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents Europe GmbH

Countries where clinical trial is conducted

Germany,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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