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

Completed

• Conditions: Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy Complications

• Registration Number: NCT04963881
• Lead Sponsor: Fatima Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Study First Submitted: 2021-06-18
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Patients of SLE without thrombosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
aPLS antibodies of any type and number lead to cumulative obstetric and thrombotic complication in patients of SLE.	2 years
B2 GPI is more prevalent in patients with antiphospholipid syndrome	2 years

Trial Locations

Locations (1)

Fatima Memorial Hospital; 🇵🇰 Lahore, Punjab, Pakistan