CHU Bordeaux
Bordeaux, France
NCT Number: NCT04325373
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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Notify Me18 year and older
All sexes
Observational
Bordeaux, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: first 7 postoperative days after AAA surgery
Incidence of thrombotic events
Time frame: baseline
white blood cells (G/L),
Time frame: baseline
hemoglobin (g/dL),
Time frame: baseline
platelets (G/L),
Time frame: baseline
prothrombin time ratio (%),
Time frame: baseline
INR
Time frame: baseline
aPTT ratio
Time frame: baseline
fibrinogen (g/L),
Time frame: baseline
CRP (ng/mL),
Time frame: baseline
interleukin-6 (pg/mL),
Time frame: baseline
thrombin generation test (lag time (min),
Time frame: baseline
peak (nM),
Time frame: baseline
time to peak (min),
Time frame: baseline
ETP (nM.min),
Time frame: baseline
velocity index
Time frame: baseline
von Willebrand factor (%),
Time frame: baseline
soluble P-selectin (ng/mL),
Time frame: baseline
MPO-AND (% standard)
Time frame: baseline
% of patients with preoperative atherosclerosis (number)
Time frame: baseline
% of patients with preoperative treatment by Aspirin (number)
Time frame: baseline
clamping duration (min),
Time frame: baseline
bleeding (min),
Time frame: baseline
vascular filling (ml),
Time frame: baseline
tranexamic acid administration (g),
Time frame: baseline
transfusion (pack of red blood cells, plasma volume (ml),
Time frame: baseline
amount of fibrinogen (g),
Time frame: baseline
amount of heparin (UI)
Time frame: baseline
Type of postoperative anticoagulation: % of patients with unfractionated heparin or low-molecular-weight heparin
Time frame: Baseline
Administration way of postoperative anticoagulation: % of administration intra-venous or subcutaneously
University Hospital, Bordeaux
Other
Study of Thrombotic Complications After Abdominal Aortic Aneurysm Surgery With or Without Infection: AAA-IT
Acronym: AAA-IT
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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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