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

Not Applicable

Terminated

• Conditions: Acute Coronary Syndrome
• Interventions: Procedure: Blood sampling and analysis

• Registration Number: NCT04625764
• Lead Sponsor: CytoSorbents Europe GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-12
• Study Start: 2021-02-23
• Primary Completion: 2021-10-14
• Study Completion: 2021-12-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB	Blood sampling and analysis	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

University Hospital Essen; 🇩🇪 Essen, Germany

Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle; 🇱🇺 Luxembourg, Luxembourg

Asklepios Hospital St. Georg Hamburg; 🇩🇪 Hamburg, Germany

University Hospital Jena; 🇩🇪 Jena, Germany