Hematological Markers MPV, PLR, and NLR in Primary Versus Secondary Antiphospholipid Syndrome

NCT ID: NCT07142239

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-27

Study Completion Date

2027-06-30

Brief Summary

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Antiphospholipid syndrome is a thrombo-inflammatory autoimmune disorder with a complex antiphospholipid antibody-mediated pathogenesis, and high heterogeneity in clinical presentation and disease course. Clinical presentation in antiphospholipid syndrome includes venous and arterial thrombosis, pregnancy complications, and a broad range of microvascular and non-thrombotic manifestations

Detailed Description

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APS may manifest as a primary, isolated condition or as a secondary disorder in conjunction with other autoimmune diseases, notably systemic lupus erythematosus (SLE) . The syndrome presents in two primary forms: thrombotic APS, marked by blood clots in both venous and arterial vessels, and obstetric APS (OAPS). While the criteria for APS diagnosis emphasize specific clinical and laboratory findings, recent research highlights the variability in antibody profiles and the potential for seronegative APS cases, complicating both diagnosis and management. Of note, thrombocytopenia is likely associated with more severe disease, and prolonged mild to moderate thrombocytopenia is linked to decreased long-term survival.

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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Antiphospholipid Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Primary APS

• Complete blood count , MPV

Intervention Type DIAGNOSTIC_TEST

CBC report

Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:

Intervention Type DIAGNOSTIC_TEST

CBC report

Antiphospholipid antibody profile

Intervention Type DIAGNOSTIC_TEST

Patient record

2

secondary APS

• Complete blood count , MPV

Intervention Type DIAGNOSTIC_TEST

CBC report

Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:

Intervention Type DIAGNOSTIC_TEST

CBC report

Antiphospholipid antibody profile

Intervention Type DIAGNOSTIC_TEST

Patient record

Interventions

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• Complete blood count , MPV

CBC report

Intervention Type DIAGNOSTIC_TEST

Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:

CBC report

Intervention Type DIAGNOSTIC_TEST

Antiphospholipid antibody profile

Patient record

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults (age ≥18 years)
* 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

* Current infection or inflammatory condition unrelated to APS
* Hematological malignancies or other blood disorders
* Recent blood transfusion or platelet-altering medications other than APS treatments
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Valley University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nady Hussein

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Asmaa Nady Hussein, MD

Role: CONTACT

01065161752

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.

Reference Type BACKGROUND
PMID: 24464962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35536236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37633337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31508844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36143451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34605138 (View on PubMed)

Other Identifiers

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HEM-APS

Identifier Type: -

Identifier Source: org_study_id

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