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

NCT ID: NCT04625764

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2021-12-14

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB

Group Type: EXPERIMENTAL

Blood sampling and analysis

Intervention Type: PROCEDURE

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

Interventions

Blood sampling and analysis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytoSorbents Europe GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kambiz Hassan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany

Locations

University Hospital Essen

Essen, , Germany

Asklepios Hospital St. Georg Hamburg

Hamburg, , Germany

University Hospital Jena

Jena, , Germany

Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle

Luxembourg, , Luxembourg

Countries

Germany; Luxembourg

Other Identifiers

CSI17

Identifier Type: -

Identifier Source: org_study_id