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Completed

NCT Number: NCT04325373

Abdominal Aortic Aneurysm Surgery and Thrombosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. thrombotic events

    Time frame: first 7 postoperative days after AAA surgery

    Incidence of thrombotic events

Secondary outcomes

  1. white blood cells

    Time frame: baseline

    white blood cells (G/L),

  2. hemoglobin

    Time frame: baseline

    hemoglobin (g/dL),

  3. platelets

    Time frame: baseline

    platelets (G/L),

  4. prothrombin time ratio

    Time frame: baseline

    prothrombin time ratio (%),

  5. INR

    Time frame: baseline

    INR

  6. aPTT ratio

    Time frame: baseline

    aPTT ratio

  7. fibrinogen

    Time frame: baseline

    fibrinogen (g/L),

  8. CRP

    Time frame: baseline

    CRP (ng/mL),

  9. interleukin-6

    Time frame: baseline

    interleukin-6 (pg/mL),

  10. thrombin generation test

    Time frame: baseline

    thrombin generation test (lag time (min),

  11. peak

    Time frame: baseline

    peak (nM),

  12. time to peak

    Time frame: baseline

    time to peak (min),

  13. ETP

    Time frame: baseline

    ETP (nM.min),

  14. velocity index

    Time frame: baseline

    velocity index

  15. von Willebrand factor

    Time frame: baseline

    von Willebrand factor (%),

  16. soluble P-selectin

    Time frame: baseline

    soluble P-selectin (ng/mL),

  17. MPO-AND

    Time frame: baseline

    MPO-AND (% standard)

  18. atherosclerosis

    Time frame: baseline

    % of patients with preoperative atherosclerosis (number)

  19. Aspirin treatment

    Time frame: baseline

    % of patients with preoperative treatment by Aspirin (number)

  20. clamping duration

    Time frame: baseline

    clamping duration (min),

  21. bleeding

    Time frame: baseline

    bleeding (min),

  22. vascular filling

    Time frame: baseline

    vascular filling (ml),

  23. tranexamic acid administration

    Time frame: baseline

    tranexamic acid administration (g),

  24. transfusion

    Time frame: baseline

    transfusion (pack of red blood cells, plasma volume (ml),

  25. amount of fibrinogen

    Time frame: baseline

    amount of fibrinogen (g),

  26. amount of heparin

    Time frame: baseline

    amount of heparin (UI)

  27. Type of postoperative anticoagulation

    Time frame: baseline

    Type of postoperative anticoagulation: % of patients with unfractionated heparin or low-molecular-weight heparin

  28. Administration way of postoperative anticoagulation

    Time frame: Baseline

    Administration way of postoperative anticoagulation: % of administration intra-venous or subcutaneously

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: AAA-IT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2020
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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