An observational study in Antiphospholipid Syndrome, sponsored by New Valley University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by New Valley University · Observational
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
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.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.
This study's planned enrollment of 150 is below the median of 181 across 52 observational studies indexed under Antiphospholipid Syndrome.
Browse Antiphospholipid Syndrome studies →New Valley University is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be categorized as:
Primary APS: APS without other systemic autoimmune diseases Secondary APS: APS associated with autoimmune diseases such as systemic lupus erythematosus (SLE)
Exclusion criteria:
Primary APS
Diagnostic Test: • Complete blood count , MPV · Diagnostic Test: Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR: · Diagnostic Test: Antiphospholipid antibody profile
secondary APS
Diagnostic Test: • Complete blood count , MPV · Diagnostic Test: Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR: · Diagnostic Test: Antiphospholipid antibody profile
CBC report
CBC report
Patient record
Measurement of Mean platelet Volume in patients diagnosed with primary APS
Time frame: Baseline
Measurement of Mean platelet Volume in patients diagnosed with secondary APS
Time frame: Baseline
Measurement of Platelet - lymphocyte ratio in patients diagnosed with primary APS and those with secondary APS
Time frame: "Baseline"
Measurement of Neutrophil - lymphocyte ratio in patients diagnosed with primary APS and those with secondary APS
Time frame: "Baseline"
Plan to share: No
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