Hematological Markers MPV, PLR, and NLR in Primary Versus Secondary Antiphospholipid Syndrome
NCT ID: NCT07142239
Last Updated: 2025-08-26
Study Results
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Basic Information
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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2025-11-27
2027-06-30
Brief Summary
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Detailed Description
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The neutrophil-lymphocyte ratio (NLR), defined as the ratio of the absolute value of neutrophils and lymphocytes in a peripheral venous blood stream, has been previously described as a non-invasive marker of the balance between the innate and adaptive immune response: neutrophils and lymphocytes are indeed indicators, respectively, of an active inflammatory state and of the regulatory pathway's activity in the immune system. Prior studies demonstrated that NLR is an easily available, cheap and widespread biomarker of systemic inflammation as well as a valid prognostic marker in multiple conditions, including cardiovascular, infectious, and chronic inflammatory diseases.
Alongside NLR, the platelet-to-lymphocyte ratio (PLR) has recently gained attention as a simple, cost-effective, and dependable marker that reflects inflammation, atherosclerosis, and cellular immune activation. An increased NLR, which represents the interaction between innate immunity driven mainly by neutrophils and adaptive immunity mediated by lymphocytes, and elevated PLR, as an indicator of inflammation and immune response, have been linked to acute thrombotic complications and are predictive of mortality in patients with solid tumors. However, their comparative evaluation between primary and secondary antiphospholipid syndrome (APS) remains limited.
Given the significant roles of inflammation, neutrophils, and platelets in the pathogenesis of venous thromboembolism (VTE), there has been growing interest in these parameters. NLR and PLR, both derived easily from complete blood counts, reflect primary hemostasis and inflammatory status. These ratios are minimally influenced by factors such as age, sex, and various physiological or pathological conditions, thereby potentially offering greater accuracy in detecting deep vein thrombosis (DVT) compared to other blood-based indices.
It is also noted that larger platelets are metabolically more active compared to smaller ones, producing higher quantities of β-thromboglobulin and thromboxane A2, substances associated with enhanced platelet activity, including increased expression of adhesion molecules and heightened aggregation ability.
NLR serves as an effective measure of systemic inflammation by reflecting the relative levels of neutrophils and lymphocytes. Substantial evidence now supports elevated NLR as a potential diagnostic and prognostic marker in a variety of cardiovascular and cerebrovascular diseases.
Similarly, PLR has been demonstrated to reliably reflect systemic inflammatory responses and is useful in predicting prognosis and outcomes in various conditions.
Mean platelet volume (MPV), which measures the average size of platelets in the blood, serves as an important parameter reflecting platelet function and activation, playing a key role in both inflammation and atherosclerosis.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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1
Primary APS
• Complete blood count , MPV
CBC report
Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:
CBC report
Antiphospholipid antibody profile
Patient record
2
secondary APS
• Complete blood count , MPV
CBC report
Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:
CBC report
Antiphospholipid antibody profile
Patient record
Interventions
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• Complete blood count , MPV
CBC report
Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:
CBC report
Antiphospholipid antibody profile
Patient record
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of APS based on updated Sydney classification criteria confirmed by: Clinical history of thrombosis and/or pregnancy morbidity, Persistent presence (≥12 weeks) of antiphospholipid antibodies (aCL, anti-β2-glycoprotein I, and/or lupus anticoagulant)
Exclusion Criteria
* Hematological malignancies or other blood disorders
* Recent blood transfusion or platelet-altering medications other than APS treatments
18 Years
ALL
No
Sponsors
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New Valley University
OTHER
Responsible Party
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Asmaa Nady Hussein
Lecturer
Central Contacts
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References
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Cervera R, Serrano R, Pons-Estel GJ, Ceberio-Hualde L, Shoenfeld Y, de Ramon E, Buonaiuto V, Jacobsen S, Zeher MM, Tarr T, Tincani A, Taglietti M, Theodossiades G, Nomikou E, Galeazzi M, Bellisai F, Meroni PL, Derksen RH, de Groot PG, Baleva M, Mosca M, Bombardieri S, Houssiau F, Gris JC, Quere I, Hachulla E, Vasconcelos C, Fernandez-Nebro A, Haro M, Amoura Z, Miyara M, Tektonidou M, Espinosa G, Bertolaccini ML, Khamashta MA; Euro-Phospholipid Project Group (European Forum on Antiphospholipid Antibodies). Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients. Ann Rheum Dis. 2015 Jun;74(6):1011-8. doi: 10.1136/annrheumdis-2013-204838. Epub 2014 Jan 24.
Shi Y, Zhao J, Jiang H, Huang C, Qi W, Song Y, Wang Q, Li M, Tian X, Zhao Y, Zeng X. Thrombocytopenia in primary antiphospholipid syndrome: association with prognosis and clinical implications. Rheumatology (Oxford). 2022 Dec 23;62(1):256-263. doi: 10.1093/rheumatology/keac264.
Garcia-Escobar A, Vera-Vera S, Tebar-Marquez D, Rivero-Santana B, Jurado-Roman A, Jimenez-Valero S, Galeote G, Cabrera JA, Moreno R. Neutrophil-to-lymphocyte ratio an inflammatory biomarker, and prognostic marker in heart failure, cardiovascular disease and chronic inflammatory diseases: New insights for a potential predictor of anti-cytokine therapy responsiveness. Microvasc Res. 2023 Nov;150:104598. doi: 10.1016/j.mvr.2023.104598. Epub 2023 Aug 24.
Farah R, Nseir W, Kagansky D, Khamisy-Farah R. The role of neutrophil-lymphocyte ratio, and mean platelet volume in detecting patients with acute venous thromboembolism. J Clin Lab Anal. 2020 Jan;34(1):e23010. doi: 10.1002/jcla.23010. Epub 2019 Sep 11.
Lattanzi S, Norata D, Broggi S, Meletti S, Switonska M, Slomka A, Silvestrini M. Neutrophil-to-Lymphocyte Ratio Predicts Early Neurological Deterioration after Endovascular Treatment in Patients with Ischemic Stroke. Life (Basel). 2022 Sep 10;12(9):1415. doi: 10.3390/life12091415.
Morkavuk SB, Kocaoz S, Korukluoglu B. Diagnostic value of Platelet/lymphocyte Ratio (PLR) for predicting sentinel axillary lymph node positivity in early-stage breast cancer compared with ultrasonography. Int J Clin Pract. 2021 Dec;75(12):e14939. doi: 10.1111/ijcp.14939. Epub 2021 Oct 12.
Other Identifiers
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HEM-APS
Identifier Type: -
Identifier Source: org_study_id
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