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

University of Oslo (UIO)

Status: Completed

Conditions: Factor X Inhibition; Aortic Dissection

Study type: Observational

Funder types: Other

Identifiers

NCT05235178

20/27731

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

Study group

Description:

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.