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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04625764

Acronym

CyTation

Enrollment

Registered

2020-11-12

Start date

2021-02-23

Completion date

2021-12-14

Last updated

2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREBlood sampling and analysis

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Platelet reactivity	8 hours	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.

Countries

Germany, Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026