Emergent Cardiothoracic SurgeryTISORBNCT04131959
Ticagrelor CytoSorb Hemoadsorption
A study testing CytoSorb 300 mL device in people with Emergent Cardiothoracic Surgery and Bleeding, run by CytoSorbents, Inc at 8 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Emergent Cardiothoracic Surgery, Bleeding, Drug Removal
- What is being tested?
- CytoSorb 300 mL device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 29 Oct 2019to 4 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.
Who cannot join
- Any cardiothoracic surgery > 48 hours after last dose of ticagrelor.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Queen Elizabeth Hospital
Birmingham, England, B15 2TH
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
Golden Jubilee National Hospital
Glasgow, Scotland, G81 4DY
Harefield Hospital
Harefield, England, UB9 6JH
Manchester Royal Infirmary
Manchester, England, M13 9WL
Northern General Hospital
Sheffield, England, S5 7AU
About this study
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
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.
- Conditions
- Emergent Cardiothoracic Surgery, Bleeding, Drug Removal
- Being tested
- CytoSorb 300 mL device
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb 300 mL deviceDevice
Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Pharmacodynamic population | Experimental | Single arm Receives: Device: CytoSorb 300 mL device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately before and after cardiopulmonary bypass
Primary Pharmacokinetic Endpoint
Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.
Measured: Immediately before and after cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start29 Oct 2019
- Primary completion4 May 2021
- Study completion4 May 2021
Why it stopped: Stalled study execution from the impact of the COVID-19 pandemic on the UK NHS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Emergent Cardiothoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open, multi-center, single arm study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Clutton-Brock, MB, ChB, Principal investigator, NIHR Trauma Management, MedTech Cooperative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131959
- Sponsor's protocol ID
- 2018-002
- Other IDs
- IRAS project ID 264064
- Acronym
- TISORB
- Status last verified
- Feb 2022
- First submitted
- 15 Oct 2019
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04131959
- Acronym / sponsor ID
- TISORB / 2018-002
- Conditions
- Emergent Cardiothoracic Surgery, Bleeding, Drug Removal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stalled study execution from the impact of the COVID-19 pandemic on the UK NHS
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open, multi-center, single arm study
| Arm | Type | Receives |
|---|---|---|
| Pharmacodynamic population | Experimental | Device: CytoSorb 300 mL deviceSingle arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.
Key exclusion criteria (1 listed)
- Any cardiothoracic surgery > 48 hours after last dose of ticagrelor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb 300 mL deviceIntra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass | Device | Pharmacodynamic population |
Primary outcome
Primary Pharmacodynamic Endpoint
Time frame: 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
Time frame: Immediately before and after cardiopulmonary bypass
Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Clutton-Brock, MB, ChB principal investigator
NIHR Trauma Management, MedTech Cooperative
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb 300 mL device in people with Emergent Cardiothoracic Surgery and Bleeding, run by CytoSorbents, Inc at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Pharmacodynamic Endpoint (time frame: Immediately before and after cardiopulmonary bypass). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.