跳至主要内容
临床试验/NCT07142239
NCT07142239招募中不适用

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

New Valley University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Measurement of MPV in patients diagnosed with primary APS

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

1

Primary APS

干预措施: Antiphospholipid antibody profile (Diagnostic Test)

1

Primary APS

干预措施: • Complete blood count , MPV (Diagnostic Test)

1

Primary APS

干预措施: Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR: (Diagnostic Test)

2

secondary APS

干预措施: • Complete blood count , MPV (Diagnostic Test)

2

secondary APS

干预措施: Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR: (Diagnostic Test)

2

secondary APS

干预措施: Antiphospholipid antibody profile (Diagnostic Test)

结局指标

主要结局

Measurement of MPV in patients diagnosed with primary APS

时间窗: Baseline

Measurement of MPV in patients diagnosed with secondary APS

时间窗: Baseline

Measurement of Mean platelet Volume in patients diagnosed with primary APS

时间窗: Baseline

Measurement of Mean platelet Volume in patients diagnosed with secondary APS

时间窗: Baseline

compare the levels and clinical implications of hematological markers mean platelet volume (MPV), platelet-to-lymphocyte ratio (PLR), and neutrophil-to-lymphocyte ratio (NLR) between patients diagnosed with primary APS and those with secondary APS

时间窗: once

comparison

次要结局

  • Measurement of PLR in patients diagnosed with primary APS and those with secondary APS("Baseline")
  • Measurement of NLR in patients diagnosed with primary APS and those with secondary APS("Baseline")
  • Measurement of Platelet - lymphocyte ratio in patients diagnosed with primary APS and those with secondary APS("Baseline")
  • Measurement of Neutrophil - lymphocyte ratio in patients diagnosed with primary APS and those with secondary APS("Baseline")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Nady Hussein

Lecturer

New Valley University

研究点 (1)

Loading locations...

相似试验

Hematological Markers MPV, PLR, and NLR in Primary... | 临床试验