Hematological Manifestations in Systemic Lupus Erythematosus Patients

Completed

• Conditions: Systemic Lupus Erythematosus (SLE)

• Registration Number: NCT06936007
• Lead Sponsor: Patan Academy of Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-12
• Last Update Submitted: 2025-04-12
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with hematological abnormalities	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 Outcome Measures

Name	Time	Method
Percentage of SLE patients with mucocutaneous involvement	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.
Percentage of SLE patients with pericarditis	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.
Percentage of SLE patients with respiratory involvement	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.
Percentage of SLE patients with gastrointestinal involvement	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.
Percentage of SLE patients with kidney involvement	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.
Percentage of SLE patients with musculoskeletal involvement	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.
Percentage of SLE patients with neurological involvement	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.

Trial Locations

Locations (1)

Patan Hospital; 🇳🇵 Lalitpur, Bagmati Province, Nepal