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

Primary Purpose

Acute Coronary Syndrome

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blood sampling and analysis
Sponsored by
CytoSorbents Europe GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Essen
  • Asklepios Hospital St. Georg Hamburg
  • University Hospital Jena
  • Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2020
Last Updated
January 21, 2022
Sponsor
CytoSorbents Europe GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04625764
Brief Title
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to Corona pandemic, planned ammount of enrolled patient could not be reached, protocol section "Early termination of the study" - criterion "Difficulties in recruiting patients" is fully met->recruitment period will not be extended
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoSorbents Europe GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Blood sampling and analysis
Intervention Description
Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)
Primary Outcome Measure Information:
Title
Platelet reactivity
Description
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.
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kambiz Hassan, M.D.
Organizational Affiliation
Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Asklepios Hospital St. Georg Hamburg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
University Hospital Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg

12. IPD Sharing Statement

Learn more about this trial

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

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