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Abdominal Aortic Aneurysm Surgery and Thrombosis (AAA-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325373
Recruitment Status : Completed
First Posted : March 27, 2020
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease
Abdominal Aortic Aneurysm

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Study of Thrombotic Complications After Abdominal Aortic Aneurysm Surgery With or Without Infection: AAA-IT
Actual Study Start Date : November 21, 2019
Actual Primary Completion Date : January 27, 2021
Actual Study Completion Date : January 27, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. thrombotic events [ Time Frame: first 7 postoperative days after AAA surgery ]
    Incidence of thrombotic events


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with surgery for abdominal aortic aneurysm
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325373


Locations
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France
CHU Bordeaux
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04325373    
Other Study ID Numbers: CHUBX 2020/07
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
abdominal aortic aneurysm
NETosis
thrombosis
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases