Aortic DissectionCitronNCT05235178
The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection
An observational study of Aortic Dissection and Factor X Inhibition, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The direct oral anticoagulants (DOACs) and particularly the FXa inhibitors are a concern in patients presenting with type A aortic dissection as this may contribute to severe bleeding complications. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Dissection, Factor X Inhibition
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- 18 Apr 2021to 5 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are anticoagulated with FXa inhibitors beeing operated acutely for acute proximal aortic disease with the use of Cytosorb® hemadsorber intraoperatively.
Who may be able to join
- Indication for urgent surgery for proximal aortic disease
- Treatment with FXa inhibitor for more than 2 weeks
- Measured concentration of FXa inhibitor in therapeutic range (>50 ng/mL) at the time of admission.
- Intraoperative use of Cytosorb® hemadsorber.
Who cannot join
- Low FXa inhibitor concentration (<50 ng/mL) at the time of admission
Trial locations and contacts
1 site in 1 country.
About this study
The direct oral anticoagulants (DOACs) and particularly the FXa inhibitors are a concern in patients presenting with type A aortic dissection as this may contribute to severe bleeding complications. The antidote andexanet alfa (Ondexxya®) can interact with the heparin- anti-thrombin III (ATIII) complex which may neutralize the anticoagulant effect of heparin and the use of andexanet alfa before surgery necessitating heparin-anticoagulation has been reported to cause unresponsiveness to heparin. The investigators have preliminary in-vitro data demonstrating the ability to remove apixaban from reconstituted blod by hemadsorption and are now analyzing if aFXa inhibitor levels may be reduced by hemadsorption in the clinical setting analyzing this in patients using FXa inhibitors being operated acutely for type A aortic dissection.
- Conditions
- Aortic Dissection, Factor X Inhibition
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Due to catastrophic bleeding events in patients who are anticoagulated with FXa inhibitors undergoing emergency surgery on the proximal aorta and lack of antidote (not available in Norway and most likely not compatible with heparin), the department has decided to use hemadsorber in these cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apixaban concentration after 60 minutes of hemadsorption
Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples at different time-points (0, 5, 10, 30, 60, 120 minutes) during hemadsorption.
Measured: 60 minutes
Secondary outcomes (2)
Change in apixaban concentration during hemadsorption
Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples at different time-points (0, 5, 10, 30, 60, 120 minutes) during hemadsorption.
Measured: 5-120 minutes
Apixaban concentration follwing hemadsorption
Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples 24 hours after hemadsorption.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start18 Apr 2021
- Primary completion10 Jan 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Johannes Lagethon Bjørnstad, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235178
- Sponsor's protocol ID
- 20/27731
- Acronym
- Citron
- Status last verified
- Dec 2024
- First submitted
- 5 Jan 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection
- ClinicalTrials.gov ID
- NCT05235178
- Acronym / sponsor ID
- Citron / 20/27731
- Conditions
- Aortic Dissection, Factor X Inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The direct oral anticoagulants (DOACs) and particularly the FXa inhibitors are a concern in patients presenting with type A aortic dissection as this may contribute to severe bleeding complications. The antidote andexanet alfa (Ondexxya®) can interact with the heparin- anti-thrombin III (ATIII) complex which may neutralize the anticoagulant effect of heparin and the use of andexanet alfa before surgery necessitating heparin-anticoagulation has been reported to cause unresponsiveness to heparin. The investigators have preliminary in-vitro data demonstrating the ability to remove apixaban from reconstituted blod by hemadsorption and are now analyzing if aFXa inhibitor levels may be reduced by hemadsorption in the clinical setting analyzing this in patients using FXa inhibitors being operated acutely for type A aortic dissection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Due to catastrophic bleeding events in patients who are anticoagulated with FXa inhibitors undergoing emergency surgery on the proximal aorta and lack of antidote (not available in Norway and most likely not compatible with heparin), the department has decided to use hemadsorber in these cases. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are anticoagulated with FXa inhibitors beeing operated acutely for acute proximal aortic disease with the use of Cytosorb® hemadsorber intraoperatively.
Key inclusion criteria (4 listed)
- Indication for urgent surgery for proximal aortic disease
- Treatment with FXa inhibitor for more than 2 weeks
- Measured concentration of FXa inhibitor in therapeutic range (>50 ng/mL) at the time of admission.
- Intraoperative use of Cytosorb® hemadsorber.
Key exclusion criteria (1 listed)
- Low FXa inhibitor concentration (<50 ng/mL) at the time of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in apixaban concentration after 60 minutes of hemadsorption
Time frame: 60 minutes
Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples at different time-points (0, 5, 10, 30, 60, 120 minutes) during hemadsorption.
2 secondary outcomes
Change in apixaban concentration during hemadsorption
Time frame: 5-120 minutes
Apixaban concentration follwing hemadsorption
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Factor X Inhibition, run by Oslo University Hospital at 1 site in Norway.
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 4 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: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in apixaban concentration after 60 minutes of hemadsorption (time frame: 60 minutes). 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 14 May 2025.