Abdominal Aortic Aneurysm Surgery and Thrombosis

Abdominal Aortic Aneurysm Clinical Trial

— AAA-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325373
• Other study ID #: CHUBX 2020/07
• Status: Completed
• Start date: November 21, 2019
• Est. completion date: January 27, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombotic events	Incidence of thrombotic events	first 7 postoperative days after AAA surgery
Secondary	white blood cells	white blood cells (G/L),	baseline
Secondary	hemoglobin	hemoglobin (g/dL),	baseline
Secondary	platelets	platelets (G/L),	baseline
Secondary	prothrombin time ratio	prothrombin time ratio (%),	baseline
Secondary	INR	INR	baseline
Secondary	aPTT ratio	aPTT ratio	baseline
Secondary	fibrinogen	fibrinogen (g/L),	baseline
Secondary	CRP	CRP (ng/mL),	baseline
Secondary	interleukin-6	interleukin-6 (pg/mL),	baseline
Secondary	thrombin generation test	thrombin generation test (lag time (min),	baseline
Secondary	peak	peak (nM),	baseline
Secondary	time to peak	time to peak (min),	baseline
Secondary	ETP	ETP (nM.min),	baseline
Secondary	velocity index	velocity index	baseline
Secondary	von Willebrand factor	von Willebrand factor (%),	baseline
Secondary	soluble P-selectin	soluble P-selectin (ng/mL),	baseline
Secondary	MPO-AND	MPO-AND (% standard)	baseline
Secondary	atherosclerosis	% of patients with preoperative atherosclerosis (number)	baseline
Secondary	Aspirin treatment	% of patients with preoperative treatment by Aspirin (number)	baseline
Secondary	clamping duration	clamping duration (min),	baseline
Secondary	bleeding	bleeding (min),	baseline
Secondary	vascular filling	vascular filling (ml),	baseline
Secondary	tranexamic acid administration	tranexamic acid administration (g),	baseline
Secondary	transfusion	transfusion (pack of red blood cells, plasma volume (ml),	baseline
Secondary	amount of fibrinogen	amount of fibrinogen (g),	baseline
Secondary	amount of heparin	amount of heparin (UI)	baseline
Secondary	Type of postoperative anticoagulation	Type of postoperative anticoagulation: % of patients with unfractionated heparin or low-molecular-weight heparin	baseline
Secondary	Administration way of postoperative anticoagulation	Administration way of postoperative anticoagulation: % of administration intra-venous or subcutaneously	Baseline