Hematological Manifestations in Systemic Lupus Erythematosus Patients

NCT06936007 | Completed

• 1 other identifier: drs2412171972
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

hematological manifestations; Nepal; organ involvement; systemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with hematological abnormalities

  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.

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

Secondary Outcomes (7)

• Percentage of SLE patients with mucocutaneous involvement

  Through study completion from 2019 January to 2023 December.

• Percentage of SLE patients with pericarditis

  Through the study completion from 2019 January to 2023 December.

• Percentage of SLE patients with respiratory involvement

  Through the study completion from 2019 January to 2023 December.

• Percentage of SLE patients with gastrointestinal involvement

  Through the study completion from 2019 January to 2023 December.

• Percentage of SLE patients with kidney involvement

  Through the study completion from 2019 January to 2023 December.

Study Arms (1)

Systemic Lupus Erythematosus Patients

Patients diagnosed with systemic lupus erythematosus as per 2019 European League of Associations for Rheumatology and American College of Rheumatology (2019 EULAR/ACR) criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with diagnosis of systemic lupus erythematosus in medical ward of Patan Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead

Study Sites (1)

Patan Hospital

Lalitpur, Bagmati Province, 44700, Nepal

Location

Related Publications (6)

• Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.

  PMID: 31385462 BACKGROUND

• Beyan E, Beyan C, Turan M. Hematological presentation in systemic lupus erythematosus and its relationship with disease activity. Hematology. 2007 Jun;12(3):257-61. doi: 10.1080/10245330701214145.

  PMID: 17558704 BACKGROUND

• Paudyal BP, Gyawalee M. Clinical profile of patients with systemic lupus erythematosus. JNMA J Nepal Med Assoc. 2012 Jul-Sep;52(187):111-7.

  PMID: 23591169 BACKGROUND

• Talukdar D, Gogoi A, Doley D, et al. The clinical and immunological profiles of systemic lupus erythematosus patients from Assam, North-East India. Indian J Rheumatol. 2020;15(3):181. doi:10.4103/injr.injr_37_20

  BACKGROUND

• Gulati S, Kumar V, Rawat P, Chawla K, Dessai R, Jain S. Study of hematological profile of systemic lupus erythematosus. Int J Res Med Sci. 2023;11(9):3332-3335. doi:10.18203/2320-6012.ijrms20232788

  BACKGROUND

• Aleem A, Al Arfaj AS, khalil N, Alarfaj H. Haematological abnormalities in systemic lupus erythematosus. Acta Reumatol Port. 2014 Jul-Sep;39(3):236-41.

  PMID: 24861278 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 20, 2025
• Study Start: November 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)