Ticagrelor CytoSorb Hemoadsorption
- Conditions
- BleedingEmergent Cardiothoracic SurgeryDrug Removal
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.
Any cardiothoracic surgery > 48 hours after last dose of ticagrelor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Queen Elizabeth Hospital
🇬🇧Birmingham, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Harefield Hospital
🇬🇧Harefield, England, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, England, United Kingdom
Northern General Hospital
🇬🇧Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, 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