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

NCT04625764 | Terminated DMC

• 1 other identifier: CSI17
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 hours

Study Arms (1)

patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB

EXPERIMENTAL

Procedure: Blood sampling and analysis

Interventions

Blood sampling and analysis PROCEDURE

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

patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CytoSorbents Europe GmbH: lead

Study Sites (4)

University Hospital Essen

Essen, 45147, Germany

Location

Asklepios Hospital St. Georg Hamburg

Hamburg, 20099, Germany

Location

University Hospital Jena

Jena, 07747, Germany

Location

Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle

Luxembourg, 1210, Luxembourg

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kambiz Hassan, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: February 23, 2021
• Primary Completion: October 14, 2021
• Study Completion: December 14, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

DE (3); LU (1)