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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-18

Study Completion Date

2024-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

NCT07116395

Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System

NOT_YET_RECRUITING PHASE4

Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery

NCT01530399

Bleeding

TERMINATED PHASE2

Coagulation in Acute Aortic Dissection

NCT05484830

Acute Aortic Dissection Coagulation Disorder

COMPLETED NA

Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit

NCT05357079

Fracture of Posterior Wall of Acetabulum

COMPLETED EARLY_PHASE1

A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

NCT00588133

Cardiac Surgery

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Dissection Factor X Inhibition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.