Study Stopped
Stalled study execution from the impact of the COVID-19 pandemic on the UK NHS
Ticagrelor CytoSorb Hemoadsorption
TISORB
2 other identifiers
interventional
5
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedStudy Start
First participant enrolled
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedResults Posted
Study results publicly available
March 9, 2022
CompletedMarch 9, 2022
February 1, 2022
1.5 years
October 15, 2019
January 18, 2022
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Pharmacokinetic Endpoint
Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.
Immediately before and after cardiopulmonary bypass
Study Arms (1)
Pharmacodynamic population
EXPERIMENTALSingle arm
Interventions
Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass
Eligibility Criteria
You may qualify if:
- Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.
You may not qualify if:
- Any cardiothoracic surgery \> 48 hours after last dose of ticagrelor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Queen Elizabeth Hospital
Birmingham, England, B15 2TH, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR, United Kingdom
Harefield Hospital
Harefield, England, UB9 6JH, United Kingdom
Manchester Royal Infirmary
Manchester, England, M13 9WL, United Kingdom
Northern General Hospital
Sheffield, England, S5 7AU, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA, United Kingdom
Golden Jubilee National Hospital
Glasgow, Scotland, G81 4DY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CytoSorbents
- Organization
- CytoSorbents
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Clutton-Brock, MB, ChB
NIHR Trauma Management, MedTech Cooperative
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
October 15, 2019
First Posted
October 18, 2019
Study Start
October 29, 2019
Primary Completion
May 4, 2021
Study Completion
May 4, 2021
Last Updated
March 9, 2022
Results First Posted
March 9, 2022
Record last verified: 2022-02