NCT04325373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

March 9, 2020

Last Update Submit

April 11, 2022

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysmNETosisthrombosis

Outcome Measures

Primary Outcomes (1)

  • thrombotic events

    Incidence of thrombotic events

    first 7 postoperative days after AAA surgery

Secondary Outcomes (28)

  • white blood cells

    baseline

  • hemoglobin

    baseline

  • platelets

    baseline

  • prothrombin time ratio

    baseline

  • INR

    baseline

  • +23 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with surgery for abdominal aortic aneurysm

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalThrombosis

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesEmbolism and Thrombosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 27, 2020

Study Start

November 21, 2019

Primary Completion

January 27, 2021

Study Completion

January 27, 2021

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)