NCT04963881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

June 18, 2021

Last Update Submit

July 6, 2021

Conditions

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

Keywords

APLS, Thrombosis, antiphosphoilipid antibodies

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Antibody testingDIAGNOSTIC_TEST

Blood samples were taken and analyzed for APS antibodies

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • Patients of SLE without thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Memorial Hospital

Lahore, Punjab Province, 7200, Pakistan

Location

MeSH Terms

Conditions

Pregnancy ComplicationsThrombosis

Interventions

Antibody Formation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunity, ActiveAdaptive ImmunityImmunityImmune System Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 15, 2021

Study Start

October 10, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)