Abdominal Aortic AneurysmNCT05031195
Prognostic Impact of NLR, PLR, and MPV in Patients Undergoing AAA Open Repair
An observational study of Abdominal Aortic Aneurysm, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- 1st tertile, 2nd tertile, 3rd tertile
- How many people
- 334 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jan 2020to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing open AAA repair in university hospital.
Who may be able to join
- patients who underwent open repair of abdominal aortic aneurysm.
Who cannot join
- patients with previous aortic repair within 6 months.
- mycotic aneurysm.
- iliac artery aneurysm.
- aorta occlusive disease.
- incomplete data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Neutrophil to Lymphocyte Ratio, Platelet to Lymphocyte Ratio, and Mean Platelet Volume as Predictors of 1 Year Mortality in Patients Undergoing an Open Repair of Abdominal Aortic Aneurysms: a Retrospective Study
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.
Read the detailed description
The investigators will retrospectively review medical records who underwent open abdominal aortic aneurysm repair between Jan 2008 and July 2019. The investigators will divide the patients into two groups according to the occurrence of 1-yr mortality. Then the investigators compare complete blood count including NLR, PLR and MPV between the groups. Furthermore, the patient will be divided into tertiles according to the preoperative NLR, PLR, and MPV values to compare the incidence of 1-yr mortality and other morbidities. Multivariable logistic regression analysis will be performed to investigate possible prognostic factor for 1-yr mortality in these patients.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- 1st tertile, 2nd tertile, 3rd tertile
- Keywords
- neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, mean platelet volume, aortic surgery, abdominal aortic aneurysm.
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1st tertile, 2nd tertile, 3rd tertileOther
Patients will be divided into 3 groups according to the preoperative NLR value.
| Study group | Role | What they receive |
|---|---|---|
| 1st tertile | Not described Receives: Other: 1st tertile, 2nd tertile, 3rd tertile | |
| 2nd tertile | Not described Receives: Other: 1st tertile, 2nd tertile, 3rd tertile | |
| 3rd tertile | Not described Receives: Other: 1st tertile, 2nd tertile, 3rd tertile |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative 1-yr mortality
The incidence of postoperative 1-yr mortality in patients undergoing open repair of abdominal aortic aneurysm.
Measured: 1-yr after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start11 Jan 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yeon Ham, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031195
- Sponsor's protocol ID
- 3-2020-0479
- Status last verified
- Mar 2022
- First submitted
- 29 Aug 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Neutrophil to Lymphocyte Ratio, Platelet to Lymphocyte Ratio, and Mean Platelet Volume as Predictors of 1 Year Mortality in Patients Undergoing an Open Repair of Abdominal Aortic Aneurysms: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05031195
- Acronym / sponsor ID
- 3-2020-0479
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, mean platelet volume, aortic surgery, abdominal aortic aneurysm.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will retrospectively review medical records who underwent open abdominal aortic aneurysm repair between Jan 2008 and July 2019. The investigators will divide the patients into two groups according to the occurrence of 1-yr mortality. Then the investigators compare complete blood count including NLR, PLR and MPV between the groups. Furthermore, the patient will be divided into tertiles according to the preoperative NLR, PLR, and MPV values to compare the incidence of 1-yr mortality and other morbidities. Multivariable logistic regression analysis will be performed to investigate possible prognostic factor for 1-yr mortality in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open AAA repair in university hospital.
Key inclusion criteria (1 listed)
- patients who underwent open repair of abdominal aortic aneurysm.
Key exclusion criteria (5 listed)
- patients with previous aortic repair within 6 months.
- mycotic aneurysm.
- iliac artery aneurysm.
- aorta occlusive disease.
- incomplete data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1st tertile, 2nd tertile, 3rd tertilePatients will be divided into 3 groups according to the preoperative NLR value. | Other | 1st tertile, 2nd tertile, 3rd tertile |
Primary outcome
The incidence of postoperative 1-yr mortality
Time frame: 1-yr after operation
The incidence of postoperative 1-yr mortality in patients undergoing open repair of abdominal aortic aneurysm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative 1-yr mortality (time frame: 1-yr after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.