Aortic Dissection, Factor X Inhibition
Conditions
Brief 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.
Interventions
None listed
Sponsors
University of Oslo
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in apixaban concentration after 60 minutes of hemadsorption | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in apixaban concentration during hemadsorption | 5-120 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. |
| Apixaban concentration follwing hemadsorption | 24 hours | Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples 24 hours after hemadsorption. |
Countries
Norway
Outcome results
None listed