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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04963881
Enrollment
60
Registered
2021-07-15
Start date
2019-10-10
Completion date
2021-01-01
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

APLS, Thrombosis, antiphosphoilipid antibodies

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.

Interventions

DIAGNOSTIC_TESTAntibody testing

Blood samples were taken and analyzed for APS antibodies

Sponsors

Fatima Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

Inclusion criteria

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

Exclusion criteria

* Patients of SLE without thrombosis

Design outcomes

Primary

MeasureTime frame
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 syndrome2 years

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026