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

Sponsor

CytoSorbents Europe GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT04625764

Collaborator

(none)

Enrollment

Locations

Arm

9.7

Actual Duration (Months)

1.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Procedure: Blood sampling and analysis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 23, 2021

Actual Primary Completion Date :

Oct 14, 2021

Actual Study Completion Date :

Dec 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB	Procedure: Blood sampling and analysis Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)

Arm

Intervention/Treatment

Experimental: patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB

Procedure: Blood sampling and analysis

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital Essen	Essen	Germany	45147
2	Asklepios Hospital St. Georg Hamburg	Hamburg	Germany	20099
3	University Hospital Jena	Jena	Germany	07747
4	Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle	Luxembourg	Luxembourg	1210

Sponsors and Collaborators

CytoSorbents Europe GmbH

Investigators

Principal Investigator: Kambiz Hassan, M.D., Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany