Abdominal Aortic Aneurysm Surgery and Thrombosis

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT04325373
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-11-21
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Primary Completion: 2021-01-27
• Study Completion: 2021-01-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thrombotic events	first 7 postoperative days after AAA surgery	Incidence of thrombotic events

Secondary Outcome Measures

Name	Time	Method
INR	baseline	INR
aPTT ratio	baseline	aPTT ratio
peak	baseline	peak (nM),
vascular filling	baseline	vascular filling (ml),
white blood cells	baseline	white blood cells (G/L),
hemoglobin	baseline	hemoglobin (g/dL),
interleukin-6	baseline	interleukin-6 (pg/mL),
ETP	baseline	ETP (nM.min),
von Willebrand factor	baseline	von Willebrand factor (%),
CRP	baseline	CRP (ng/mL),
soluble P-selectin	baseline	soluble P-selectin (ng/mL),
Aspirin treatment	baseline	% of patients with preoperative treatment by Aspirin (number)
amount of fibrinogen	baseline	amount of fibrinogen (g),
atherosclerosis	baseline	% of patients with preoperative atherosclerosis (number)
fibrinogen	baseline	fibrinogen (g/L),
time to peak	baseline	time to peak (min),
tranexamic acid administration	baseline	tranexamic acid administration (g),
amount of heparin	baseline	amount of heparin (UI)
Administration way of postoperative anticoagulation	Baseline	Administration way of postoperative anticoagulation: % of administration intra-venous or subcutaneously
platelets	baseline	platelets (G/L),
prothrombin time ratio	baseline	prothrombin time ratio (%),
thrombin generation test	baseline	thrombin generation test (lag time (min),
velocity index	baseline	velocity index
clamping duration	baseline	clamping duration (min),
MPO-AND	baseline	MPO-AND (% standard)
bleeding	baseline	bleeding (min),
transfusion	baseline	transfusion (pack of red blood cells, plasma volume (ml),
Type of postoperative anticoagulation	baseline	Type of postoperative anticoagulation: % of patients with unfractionated heparin or low-molecular-weight heparin

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France