Clinical trial NCT04325373: Abdominal Aortic Aneurysm Surgery and Thrombosis
Official title: Study of Thrombotic Complications After Abdominal Aortic Aneurysm Surgery With or Without Infection: AAA-IT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal aortic aneurysm
NETosis
thrombosis
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with surgery for abdominal aortic aneurysm

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.

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

Primary outcomes:
measure: thrombotic events
timeFrame: first 7 postoperative days after AAA surgery
Secondary outcomes:
measure: white blood cells
timeFrame: baseline
measure: hemoglobin
timeFrame: baseline
measure: platelets
timeFrame: baseline
measure: prothrombin time ratio
timeFrame: baseline
measure: INR
timeFrame: baseline
measure: aPTT ratio
timeFrame: baseline
measure: fibrinogen
timeFrame: baseline
measure: CRP
timeFrame: baseline
measure: interleukin-6
timeFrame: baseline
measure: thrombin generation test
timeFrame: baseline
measure: peak
timeFrame: baseline
measure: time to peak
timeFrame: baseline
measure: ETP
timeFrame: baseline
measure: velocity index
timeFrame: baseline
measure: von Willebrand factor
timeFrame: baseline
measure: soluble P-selectin
timeFrame: baseline
measure: MPO-AND
timeFrame: baseline
measure: atherosclerosis
timeFrame: baseline
measure: Aspirin treatment
timeFrame: baseline
measure: clamping duration
timeFrame: baseline
measure: bleeding
timeFrame: baseline
measure: vascular filling
timeFrame: baseline
measure: tranexamic acid administration
timeFrame: baseline
measure: transfusion
timeFrame: baseline
measure: amount of fibrinogen
timeFrame: baseline
measure: amount of heparin
timeFrame: baseline
measure: Type of postoperative anticoagulation
timeFrame: baseline
measure: Administration way of postoperative anticoagulation
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: