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NCT04131959 Clinical Trial

Ticagrelor CytoSorb Hemoadsorption

Bleeding Clinical Trial

— TISORB  

Official title:
Ticagrelor CytoSorb Hemoadsorption (TISORB): 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 or Urgent Cardiothoracic Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04131959
Other study ID # 2018-002
Secondary ID IRAS project ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 29, 2019
Est. completion date May 4, 2021

Study information
Verified date February 2022
Source CytoSorbents, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

TISORB is a study to show that the CytoSorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. The hypothesis of TISORB is that removal of ticagrelor by the CytoSorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date May 4, 2021
Est. primary completion date May 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Cardiothoracic surgery requiring cardiopulmonary bypass = 48 hours following the last dose of ticagrelor. Exclusion Criteria: Any cardiothoracic surgery > 48 hours after last dose of ticagrelor.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CytoSorb 300 mL device
Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass

Locations
Country Name City State
United Kingdom Aberdeen Royal Infirmary Aberdeen Scotland
United Kingdom Queen Elizabeth Hospital Birmingham England
United Kingdom Blackpool Victoria Hospital Blackpool England
United Kingdom Royal Infirmary of Edinburgh Edinburgh Scotland
United Kingdom Golden Jubilee National Hospital Glasgow Scotland
United Kingdom Harefield Hospital Harefield England
United Kingdom Manchester Royal Infirmary Manchester England
United Kingdom Northern General Hospital Sheffield England

Sponsors (1)
Lead Sponsor Collaborator
CytoSorbents, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Pharmacodynamic Endpoint Change in platelet reactivity as measured by ADPtest on the Multiplate Analyzer immediately before and after cardiopulmonary bypass. The unit of measure is Aggregation Units (AU). Immediately before and after cardiopulmonary bypass
Primary Primary Pharmacokinetic Endpoint Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass. Immediately before and after cardiopulmonary bypass
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