Ticagrelor CytoSorb Hemoadsorption

Not Applicable

Terminated

• Conditions: Bleeding; Emergent Cardiothoracic Surgery; Drug Removal
• Interventions: Device: CytoSorb 300 mL device

• Registration Number: NCT04131959
• Lead Sponsor: CytoSorbents, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2019-10-29
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Results First Submitted: 2022-01-18
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Results First Posted: 2022-03-09
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.

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Exclusion Criteria

Any cardiothoracic surgery > 48 hours after last dose of ticagrelor.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacodynamic population	CytoSorb 300 mL device	Single arm

Primary Outcome Measures

Name	Time	Method
Primary Pharmacodynamic Endpoint	Immediately before and after cardiopulmonary bypass	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).
Primary Pharmacokinetic Endpoint	Immediately before and after cardiopulmonary bypass	Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.

Trial Locations

Locations (8)

Harefield Hospital; 🇬🇧 Harefield, England, United Kingdom

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, Scotland, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, England, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom

Golden Jubilee National Hospital; 🇬🇧 Glasgow, Scotland, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 Birmingham, England, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, England, United Kingdom

Northern General Hospital; 🇬🇧 Sheffield, England, United Kingdom