Abdominal Aortic Aneurysm Surgery and Thrombosis

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Abdominal Aortic Aneurysm Surgery and Thrombosis

Official Title

Study of Thrombotic Complications After Abdominal Aortic Aneurysm Surgery With or Without Infection: AAA-IT

Brief Summary

      The aim of our study is to evaluate the incidence of post-operative thrombotic complications
      after abdominal aortic aneurysm surgery in the context of atherosclerosis or infectious
      aneurysm and its links with preoperative inflammation and hemostasis.

Detailed Description

      Abdominal aortic aneurysm (AAA) develops in the context of atherosclerosis or infection
      (aortitis or mycotic aneurysm). AAA and its surgery are associated with pro-thrombotic
      modifications of hemostasis, which persists in the post-operative period. Pro-thrombotic
      reactions occur in the intraluminal thrombus. Inflammatory cells recruitment is mediated by
      adhesion molecules from the activated endothelium, such as "vascular cell adhesion
      molecule-1" (VCAM-1), "intercellular adhesion molecule-1" (ICAM-1), P-selectin and
      E-selectin.

      In the setting of infection, neutrophil death process occurs, the NETosis, with the
      liberation of Neutrophil Extracellular Traps (NETs), containing DNA and histones. NETs are
      associated with thrombosis and various studies have already quantified NETosis biomarkers in
      plasma from patients with thrombotic disease, such as MPO-DNA (DNA coupled myeloperoxidase).

      In the clinical perioperative setting, patients with aortitis scheduled for AAA surgery
      shwoed exhibit thrombotic events.

      The hypothesize was that patients with aortitis have an inflammatory and hemostatic
      activation different from patients who develop AAA in atherosclerotic condition, and that
      inflammation is a risk factor of postoperative thrombotic events.

Study Type

Observational

Primary Outcome

thrombotic events

Secondary Outcome

 white blood cells

Condition

Abdominal Aortic Aneurysm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

30

Start Date

March 6, 2020

Completion Date

April 30, 2021

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  patient >18 years-old;

          -  patient scheduled for AAA surgery by laparotomy in the vascular surgical unit at
             Bordeaux University Hospital;

          -  patient who gave his/her authorization for the use of its medical data and results of
             blood analyses performed on residual plasma and results of aortic material analyses

        Exclusion Criteria:

          -  patient who do not understand the study (not fluently French speaking or unable to
             give his/her consent);

          -  patient with a pre-existing hemostatic disorder;

          -  patient scheduled for an endovascular surgery and benefiting from a secondary
             laparotomy

Gender

All

Ages

18 Years - N/A

Contacts

, +33556795628, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT04325373

Organization ID

CHUBX 2020/07

Responsible Party

Sponsor

Study Sponsor

University Hospital, Bordeaux

Study Sponsor

, ,

Verification Date

March 2020