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

July 6, 2021 updated by: Sheharbano Imran, Fatima Memorial Hospital

Clinical Features and Pattern of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 7200
        • Fatima Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of SLE, both genders, presenting with thrombosis or pregnancy complications were studied.

Description

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

-

Exclusion Criteria:

  • Patients of SLE without thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatima Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2019

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (ACTUAL)

July 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMHCMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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