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CompletedNCT06936007Updated Apr 20, 2025

Hematological Manifestations in Systemic Lupus Erythematosus Patients

An observational study in Systemic Lupus Erythematosus (SLE), sponsored by Patan Academy of Health Sciences. Completed at 1 site in Nepal. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Patan Academy of Health Sciences · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
99
Sex
All
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Study 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.

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Conditions studied

  • Systemic Lupus Erythematosus (SLE)

Keywords

  • hematological manifestations
  • Nepal
  • organ involvement
  • systemic lupus erythematosus
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In context

Lupus Erythematosus, Systemic

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

This study's enrollment of 99 is below the median of 151 across 280 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Patan Academy of Health Sciences is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
99 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

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.

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

Secondary outcomes

  1. Percentage of SLE patients with mucocutaneous involvement

    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.

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

  2. Percentage of SLE patients with pericarditis

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

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

  3. Percentage of SLE patients with respiratory involvement

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

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

  4. Percentage of SLE patients with gastrointestinal involvement

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

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

  5. Percentage of SLE patients with kidney involvement

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

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

  6. Percentage of SLE patients with musculoskeletal involvement

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

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

  7. Percentage of SLE patients with neurological involvement

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

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

07

Study locations

1 site
  • Patan Hospital
    Lalitpur, Bagmati Province 44700, Nepal
08

References and documents

Publications

  • 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. PubMed 31385462 ↗
  • 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. PubMed 17558704 ↗
  • Paudyal BP, Gyawalee M. Clinical profile of patients with systemic lupus erythematosus. JNMA J Nepal Med Assoc. 2012 Jul-Sep;52(187):111-7. PubMed 23591169 ↗
  • 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
  • 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
  • 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. PubMed 24861278 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06936007
Lead sponsor
Patan Academy of Health Sciences
Responsible party
Krishna Adhikari (Lecturer, Patan Academy of Health Sciences) — Principal investigator
First posted
Apr 20, 2025
Start date
Nov 1, 2024
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024
Last update
Apr 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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