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临床试验/NCT04325373
NCT04325373已完成不适用

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

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
thrombotic events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

thrombotic events

时间窗: first 7 postoperative days after AAA surgery

Incidence of thrombotic events

次要结局

  • white blood cells(baseline)
  • hemoglobin(baseline)
  • INR(baseline)
  • aPTT ratio(baseline)
  • peak(baseline)
  • interleukin-6(baseline)
  • ETP(baseline)
  • von Willebrand factor(baseline)
  • CRP(baseline)
  • soluble P-selectin(baseline)
  • Aspirin treatment(baseline)
  • amount of fibrinogen(baseline)
  • atherosclerosis(baseline)
  • fibrinogen(baseline)
  • time to peak(baseline)
  • tranexamic acid administration(baseline)
  • amount of heparin(baseline)
  • Administration way of postoperative anticoagulation(Baseline)
  • vascular filling(baseline)
  • platelets(baseline)
  • prothrombin time ratio(baseline)
  • thrombin generation test(baseline)
  • velocity index(baseline)
  • clamping duration(baseline)
  • MPO-AND(baseline)
  • bleeding(baseline)
  • transfusion(baseline)
  • Type of postoperative anticoagulation(baseline)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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