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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Apixaban concentration follwing hemadsorption |
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Inclusion Criteria:
Exclusion Criteria:
• Low FXa inhibitor concentration (<50 ng/mL) at the time of admission
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Patients who are anticoagulated with FXa inhibitors beeing operated acutely for acute proximal aortic disease with the use of Cytosorb® hemadsorber intraoperatively.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0450 | Norway |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood samples
Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples 24 hours after hemadsorption. |
| 24 hours |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |