- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254211
Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in EVAR
April 27, 2021 updated by: Elena Arnaoutoglou, University of Thessaly
Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in Endovascular Aneurysm Repair for Abdominal Aorticaneurysm
This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.
Study Overview
Detailed Description
The study included 230 consecutive AAA patients, treated electively by EVAR from March 2016 to February 2019.
The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause.
Study Type
Observational
Enrollment (Actual)
230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Thessaly
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Larissa, Thessaly, Greece, 41110
- Univeristy of Thessaly
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study included consecutive AAA patients treated electively by EVAR
Description
Inclusion Criteria:
- AAA
- Elective
- EVAR
Exclusion Criteria:
- Emergency
- Open surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
EVAR
Patinets with AAA, treated electively by EVAR.
The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.
Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause
|
neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NLR major cardiovascular events (MACE)
Time Frame: Day 4 postopertively
|
NLR indicator for major cardiovascular events (MACE)
|
Day 4 postopertively
|
PLR major cardiovascular events (MACE)
Time Frame: Day 4 postopertively
|
PLR indicator for major cardiovascular events (MACE)
|
Day 4 postopertively
|
NLR acute kidney injury (AKI)
Time Frame: Day 4 postopertively
|
NLR indicator for acute kidney injury (AKI)
|
Day 4 postopertively
|
PLR acute kidney injury (AKI)
Time Frame: Day 4 postopertively
|
PLR indicator for acute kidney injury (AKI)
|
Day 4 postopertively
|
NLR death
Time Frame: Day 4 postopertively
|
NLR indicator for death
|
Day 4 postopertively
|
PLR death
Time Frame: Day 4 postopertively
|
PLR indicator for death
|
Day 4 postopertively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Ntalouka, MD, University Hospital of Larissa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
January 5, 2020
First Submitted That Met QC Criteria
February 2, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NLR, PLR in EVAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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