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NCT05235178 Clinical Trial

The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection

Aortic Dissection Clinical Trial

— Citron  

Official title:
The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05235178
Other study ID # 20/27731
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 18, 2021
Est. completion date December 2024

Study information
Verified date April 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 11
Est. completion date December 2024
Est. primary completion date January 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: • Low FXa inhibitor concentration (<50 ng/mL) at the time of admission

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 60 minutes
Secondary 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. 5-120 minutes
Secondary Apixaban concentration follwing hemadsorption Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples 24 hours after hemadsorption. 24 hours
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