Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 9:45 PM
Study NCT ID:
NCT05031195
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2021-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Impact of NLR, PLR, and MPV in Patients Undergoing AAA Open Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2021-08-29', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative 1-yr mortality', 'timeFrame': '1-yr after operation', 'description': 'The incidence of postoperative 1-yr mortality in patients undergoing open repair of abdominal aortic aneurysm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neutrophil to lymphocyte ratio', 'platelet to lymphocyte ratio', 'mean platelet volume', 'aortic surgery', 'abdominal aortic aneurysm.'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing open AAA repair in university hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent open repair of abdominal aortic aneurysm.\n\nExclusion Criteria:\n\n* patients with previous aortic repair within 6 months.\n* mycotic aneurysm.\n* iliac artery aneurysm.\n* aorta occlusive disease.\n* incomplete data.'}, 'identificationModule': {'nctId': 'NCT05031195', 'briefTitle': 'Prognostic Impact of NLR, PLR, and MPV in Patients Undergoing AAA Open Repair', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '3-2020-0479'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1st tertile', 'interventionNames': ['Other: 1st tertile, 2nd tertile, 3rd tertile']}, {'label': '2nd tertile', 'interventionNames': ['Other: 1st tertile, 2nd tertile, 3rd tertile']}, {'label': '3rd tertile', 'interventionNames': ['Other: 1st tertile, 2nd tertile, 3rd tertile']}], 'interventions': [{'name': '1st tertile, 2nd tertile, 3rd tertile', 'type': 'OTHER', 'description': 'Patients will be divided into 3 groups according to the preoperative NLR value.', 'armGroupLabels': ['1st tertile', '2nd tertile', '3rd tertile']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sung Yeon Ham', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}