NCT05031195

Brief Summary

Abdominal aortic aneurysm (AAA) is a multifactorial degenerative disorder, which if untreated might lead to catastrophic complications. The treatment for AAA includes open and endovascular repair, both of which carry a significant degree of risk. Thus, researchers have performed several studies addressing simple and readily available risk stratification markers, such as complete blood count in patients undergoing open AAA repair. The neutrophil to lymphocyte ratio (NLR) has been frequently used as a marker of systemic inflammatory response, which reflects neutrophilia and lymphopenia. The primary pathophysiology of AAA involves chronic inflammation in the aortic wall and atherosclerosis, accompanied with thrombosis. NLR was proposed as a fair indicator for poor prognosis in patients with AAA. The mean platelet volume (MPV) is the marker of platelet activation and an indicator of the activation of thrombus formation. Moreover, it is reportedly associated with the prognosis of patients with cardiovascular diseases. Moreover, the platelet to lymphocyte ratio (PLR) suggests thrombosis and inflammation and indicates a high risk of cardiovascular events in various groups of patients. The PLR is associated with poor prognosis following AAA repair. Despite accumulating evidence for the prognostic value of white blood cell counts in abdominal aortic aneurysm, few studies have investigated the value of these parameters, including NLR, MPV, and PLR, in patients undergoing AAA open repair. The investigators aimed to investigate if preoperative neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), or mean platelet volume (MPV) could be used to predict 1-year mortality in patients undergoing open abdominal aortic aneurysm (AAA) repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

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

January 11, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

August 29, 2021

Last Update Submit

March 23, 2022

Conditions

Keywords

neutrophil to lymphocyte ratioplatelet to lymphocyte ratiomean platelet volumeaortic surgeryabdominal aortic aneurysm.

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative 1-yr mortality

    The incidence of postoperative 1-yr mortality in patients undergoing open repair of abdominal aortic aneurysm.

    1-yr after operation

Study Arms (3)

1st tertile

Other: 1st tertile, 2nd tertile, 3rd tertile

2nd tertile

Other: 1st tertile, 2nd tertile, 3rd tertile

3rd tertile

Other: 1st tertile, 2nd tertile, 3rd tertile

Interventions

Patients will be divided into 3 groups according to the preoperative NLR value.

1st tertile2nd tertile3rd tertile

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing open AAA repair in university hospital.

You may qualify if:

  • patients who underwent open repair of abdominal aortic aneurysm.

You may not qualify if:

  • patients with previous aortic repair within 6 months.
  • mycotic aneurysm.
  • iliac artery aneurysm.
  • aorta occlusive disease.
  • incomplete data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 29, 2021

First Posted

September 1, 2021

Study Start

January 11, 2020

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations