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Идёт набор NCT07142239

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

Наблюдательное Antiphospholipid Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: • Complete blood count , MPV, Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:, Antiphospholipid antibody profile.
Кому может быть актуально
Состояния в реестре: Antiphospholipid Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Диагностический тест • Complete blood count , MPV
    CBC report
  • Диагностический тест Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:
    CBC report
  • Диагностический тест Antiphospholipid antibody profile
    Patient record

Первичные конечные точки

  • Measurement of Mean platelet Volume in patients diagnosed with primary APS [Срок оценки: Baseline]
  • Measurement of Mean platelet Volume in patients diagnosed with secondary APS [Срок оценки: Baseline]
Вторичные конечные точки (2)
  • Measurement of Platelet - lymphocyte ratio in patients diagnosed with primary APS and those with secondary APS [Срок оценки: "Baseline"]
  • Measurement of Neutrophil - lymphocyte ratio in patients diagnosed with primary APS and those with secondary APS [Срок оценки: "Baseline"]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Египет · 1 центр
  • New Valley University — Al Khārjah

Публикации

  • 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, B PMID 24464962
  • 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. PMID 35536236
  • 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;150:104 PMID 37633337
  • 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. PMID 31508844
  • 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. PMID 36143451
  • 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. PMID 34605138

Идентификаторы

NCT: NCT07142239 · HEM-APS

Первоисточники (государственные реестры)

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