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Completed

NCT Number: NCT06936007

Hematological Manifestations in Systemic Lupus Erythematosus Patients

The goal of this observational study is to evaluate hematological abnormalities among patients with systemic lupus erythematosus (SLE) admitted to a tertiary care center in Nepal. The main question it aims to answer is:

- What are the types and frequencies of hematological abnormalities seen in hospitalized SLE patients in Nepal?

The study retrospectively reviews medical records of SLE patients admitted between April 2018 and March 2023 to collect data on hematologic parameters, demographic profiles, clinical manifestations.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Patan Hospital

Lalitpur, Bagmati Province, 44700, Nepal

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All the patient diagnosed with systemic lupus erythematosus based on 2019 European League of Associations for Rheumatology and American College of Rheumatology (2019 EULAR/ACR) criteria.

Exclusion criteria

  • Underlying hematological diseases or conditions: Patients who had hematological disease (e.g. hemophilia, leukemia, lymphoma) or conditions that could independently affect hematological parameters.
  • Incomplete records

Treatment and study plan

Primary outcomes

  1. Percentage of patients with hematological abnormalities

    Time frame: Baseline at the time of hospital admission. (Cross-sectional)

    Anemia was defined as a Hb of less than 13 g/dL in males and less than 12 g/dL in females.

    Leukopenia was defined as a WBC of less than 4000 per cubic millimeter (cu.mm). Thrombocytopenia was defined as a platelet count of less than 100,000 per cubic millimeter.

    Lymphopenia and neutropenia were defined as absolute lymphocyte count less than 1500 per cu.mm and absolute neutrophil count less than 1800 per cu.mm.

Secondary outcomes

  1. Percentage of SLE patients with mucocutaneous involvement

    Time frame: Through study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting at least one mucocutaneous manifestation (malar rash, discoid rash, alopecia, or oral ulcers) based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

  2. Percentage of SLE patients with pericarditis

    Time frame: Through the study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting pericarditis based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

  3. Percentage of SLE patients with respiratory involvement

    Time frame: Through the study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting respiratory involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

  4. Percentage of SLE patients with gastrointestinal involvement

    Time frame: Through the study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting gastrointestinal involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

  5. Percentage of SLE patients with kidney involvement

    Time frame: Through the study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting kidney involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

  6. Percentage of SLE patients with musculoskeletal involvement

    Time frame: Through the study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting musculoskeletal involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

  7. Percentage of SLE patients with neurological involvement

    Time frame: Through the study completion from 2019 January to 2023 December.

    Proportion of patients exhibiting neurological involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.

Sponsors and collaborators

Lead sponsor

Patan Academy of Health Sciences

Other

Registry information

Official study title

Hematological Manifestations in Systemic Lupus Erythematosus: A Retrospective Cross-sectional Study From a Tertiary Care Center in Nepal

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

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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