Clinical trial NCT06936007: Hematological Manifestations in Systemic Lupus Erythematosus Patients
Official title: Hematological Manifestations in Systemic Lupus Erythematosus: A Retrospective Cross-sectional Study From a Tertiary Care Center in Nepal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: hematological manifestations
Nepal
organ involvement
systemic lupus erythematosus
Lead sponsor: Patan Academy of Health Sciences
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with diagnosis of systemic lupus erythematosus in medical ward of Patan Hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with hematological abnormalities
timeFrame: Baseline at the time of hospital admission. (Cross-sectional)
Secondary outcomes:
measure: Percentage of SLE patients with mucocutaneous involvement
timeFrame: Through study completion from 2019 January to 2023 December.
measure: Percentage of SLE patients with pericarditis
timeFrame: Through the study completion from 2019 January to 2023 December.
measure: Percentage of SLE patients with respiratory involvement
timeFrame: Through the study completion from 2019 January to 2023 December.
measure: Percentage of SLE patients with gastrointestinal involvement
timeFrame: Through the study completion from 2019 January to 2023 December.
measure: Percentage of SLE patients with kidney involvement
timeFrame: Through the study completion from 2019 January to 2023 December.
measure: Percentage of SLE patients with musculoskeletal involvement
timeFrame: Through the study completion from 2019 January to 2023 December.
measure: Percentage of SLE patients with neurological involvement
timeFrame: Through the study completion from 2019 January to 2023 December.
Other outcomes:
Locations:
city: Lalitpur
country: Nepal
facility: Patan Hospital
state: Bagmati Province
Study officials:
References:
citation: 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.
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citation: 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
citation: 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
citation: 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.