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Completed

NCT Number: NCT04963881

Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).

Evaluation of antiphospholipid antibodies (aPL) profile in Systemic lupus erythematosus (SLE) patients with obstetric and thrombotic complications.

Blood sample of the patients were taken for Anti-beta-2-glycoprotein 1(anti-b2GPI), anticardiolipin (aCL) and will be analyzed on Alegria based on ELISA.

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Key information

About this study

Antiphospholipid syndrome (APS) is characterized by presence of specific antiphospholipid antibodies (aPL) with history of thrombosis and/or pregnancy morbidity.

Anti-phospholipid antibodies (aPL) is a comprehensive antibody profile which includes lupus anticoagulant [LA], anticardiolipin antibodies [aCL], and/or anti-β2-glycoprotein-I antibodies [aβ2GPI]). A comprehensive antibody profile is needed for both diagnosis and classification of patients with APS, most significantly for the risk assessment of both pregnancy morbidity and thrombosis.

Double positivity (LA, aβ2GPI or ACL +) and triple positivity (LA, aβ2GPI+, ACL +) may have worse outcome and the patients with double and triple positivity may have recurrent thrombotic events.

Early detection of aPL antibodies may avert patients with many complication associated with SLE as well as from major thrombotic events because the detection of aPL in SLE has been proposed as a predictive and specific tool for the diagnosis of APLS in SLE.

aPL profile in SLE patients with obstetric and thrombotic complications was analyzed, to see the association of different anti phospholipid antibodies with different clinical features of APLS in SLE patients.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed patients of SLE presenting with thrombosis & pregnancy complication were studied

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Exclusion criteria

  • Patients of SLE without thrombosis

Treatment and study plan

Antibody testing

Diagnostic Test

Blood samples were taken and analyzed for APS antibodies

Primary outcomes

  1. aPLS antibodies of any type and number lead to cumulative obstetric and thrombotic complication in patients of SLE.

    Time frame: 2 years

  2. B2 GPI is more prevalent in patients with antiphospholipid syndrome

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Official study title

Clinical Features and Pattern of Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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