AzTrials
AzTrials

Abdominal Aortic AneurysmAAA-ITNCT04325373

Abdominal Aortic Aneurysm Surgery and Thrombosis

An observational study of Abdominal Aortic Aneurysm, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Abdominal Aortic Aneurysm
How many people
40 participants
Where
1 siteFrance
Study dates
21 Nov 2019to 27 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with surgery for abdominal aortic aneurysm

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Bordeaux

    Bordeaux

Other trials in France

About this study

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

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.

Read the 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.

Keywords
abdominal aortic aneurysm, NETosis, thrombosis
Medical subject headings
Aortic Aneurysm, Abdominal, Thrombosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. thrombotic events

    Incidence of thrombotic events

    Measured: first 7 postoperative days after AAA surgery

Secondary outcomes (28)

  1. white blood cells

    white blood cells (G/L),

    Measured: baseline

  2. hemoglobin

    hemoglobin (g/dL),

    Measured: baseline

  3. platelets

    platelets (G/L),

    Measured: baseline

  4. prothrombin time ratio

    prothrombin time ratio (%),

    Measured: baseline

  5. INR

    INR

    Measured: baseline

  6. aPTT ratio

    aPTT ratio

    Measured: baseline

  7. fibrinogen

    fibrinogen (g/L),

    Measured: baseline

  8. CRP

    CRP (ng/mL),

    Measured: baseline

  9. interleukin-6

    interleukin-6 (pg/mL),

    Measured: baseline

  10. thrombin generation test

    thrombin generation test (lag time (min),

    Measured: baseline

  11. peak

    peak (nM),

    Measured: baseline

  12. time to peak

    time to peak (min),

    Measured: baseline

  13. ETP

    ETP (nM.min),

    Measured: baseline

  14. velocity index

    velocity index

    Measured: baseline

  15. von Willebrand factor

    von Willebrand factor (%),

    Measured: baseline

  16. soluble P-selectin

    soluble P-selectin (ng/mL),

    Measured: baseline

  17. MPO-AND

    MPO-AND (% standard)

    Measured: baseline

  18. atherosclerosis

    % of patients with preoperative atherosclerosis (number)

    Measured: baseline

  19. Aspirin treatment

    % of patients with preoperative treatment by Aspirin (number)

    Measured: baseline

  20. clamping duration

    clamping duration (min),

    Measured: baseline

  21. bleeding

    bleeding (min),

    Measured: baseline

  22. vascular filling

    vascular filling (ml),

    Measured: baseline

  23. tranexamic acid administration

    tranexamic acid administration (g),

    Measured: baseline

  24. transfusion

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

    Measured: baseline

  25. amount of fibrinogen

    amount of fibrinogen (g),

    Measured: baseline

  26. amount of heparin

    amount of heparin (UI)

    Measured: baseline

  27. Type of postoperative anticoagulation

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

    Measured: baseline

  28. Administration way of postoperative anticoagulation

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start21 Nov 2019
  3. Primary completion27 Jan 2021
  4. Study completion27 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325373
Sponsor's protocol ID
CHUBX 2020/07
Acronym
AAA-IT
Status last verified
Apr 2022
First submitted
9 Mar 2020
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Abdominal Aortic Aneurysm, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

thrombotic events (time frame: first 7 postoperative days after AAA surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in