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Abdominal Aortic Aneurysm Surgery and Thrombosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04325373
Acronym
AAA-IT
Enrollment
40
Registered
2020-03-27
Start date
2019-11-21
Completion date
2021-01-27
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysm, NETosis, thrombosis

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.

Interventions

None listed

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
thrombotic eventsfirst 7 postoperative days after AAA surgeryIncidence of thrombotic events

Secondary

MeasureTime frameDescription
hemoglobinbaselinehemoglobin (g/dL),
plateletsbaselineplatelets (G/L),
prothrombin time ratiobaselineprothrombin time ratio (%),
INRbaselineINR
aPTT ratiobaselineaPTT ratio
fibrinogenbaselinefibrinogen (g/L),
CRPbaselineCRP (ng/mL),
interleukin-6baselineinterleukin-6 (pg/mL),
thrombin generation testbaselinethrombin generation test (lag time (min),
peakbaselinepeak (nM),
time to peakbaselinetime to peak (min),
ETPbaselineETP (nM.min),
velocity indexbaselinevelocity index
white blood cellsbaselinewhite blood cells (G/L),
soluble P-selectinbaselinesoluble P-selectin (ng/mL),
MPO-ANDbaselineMPO-AND (% standard)
atherosclerosisbaseline% of patients with preoperative atherosclerosis (number)
Aspirin treatmentbaseline% of patients with preoperative treatment by Aspirin (number)
clamping durationbaselineclamping duration (min),
bleedingbaselinebleeding (min),
vascular fillingbaselinevascular filling (ml),
tranexamic acid administrationbaselinetranexamic acid administration (g),
transfusionbaselinetransfusion (pack of red blood cells, plasma volume (ml),
amount of fibrinogenbaselineamount of fibrinogen (g),
amount of heparinbaselineamount of heparin (UI)
Type of postoperative anticoagulationbaselineType of postoperative anticoagulation: % of patients with unfractionated heparin or low-molecular-weight heparin
Administration way of postoperative anticoagulationBaselineAdministration way of postoperative anticoagulation: % of administration intra-venous or subcutaneously
von Willebrand factorbaselinevon Willebrand factor (%),

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026