Systemic Lupus Erythematosus (SLE)NCT06936007
Hematological Manifestations in Systemic Lupus Erythematosus Patients
An observational study of Systemic Lupus Erythematosus (SLE), run by Patan Academy of Health Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 99 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted with diagnosis of systemic lupus erythematosus in medical ward of Patan Hospital.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hematological Manifestations in Systemic Lupus Erythematosus: A Retrospective Cross-sectional Study From a Tertiary Care Center in Nepal
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
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline at the time of hospital admission. (Cross-sectional)
Secondary outcomes (7)
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.
Measured: Through study completion from 2019 January to 2023 December.
Percentage of SLE patients with pericarditis
Proportion of patients exhibiting pericarditis based on physician-documented diagnosis following 2019 EULAR/ACR criteria.
Measured: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with respiratory involvement
Proportion of patients exhibiting respiratory involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.
Measured: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with gastrointestinal involvement
Proportion of patients exhibiting gastrointestinal involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.
Measured: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with kidney involvement
Proportion of patients exhibiting kidney involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.
Measured: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with musculoskeletal involvement
Proportion of patients exhibiting musculoskeletal involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.
Measured: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with neurological involvement
Proportion of patients exhibiting neurological involvement based on physician-documented diagnosis following 2019 EULAR/ACR criteria.
Measured: Through the study completion from 2019 January to 2023 December.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Nov 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patan Academy of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishna Adhikari, Patan Academy of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936007
- Sponsor's protocol ID
- drs2412171972
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31385462Beyan 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 17558704Paudyal BP, Gyawalee M. Clinical profile of patients with systemic lupus erythematosus. JNMA J Nepal Med Assoc. 2012 Jul-Sep;52(187):111-7.
PubMed 23591169Talukdar 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Manifestations in Systemic Lupus Erythematosus: A Retrospective Cross-sectional Study From a Tertiary Care Center in Nepal
- ClinicalTrials.gov ID
- NCT06936007
- Acronym / sponsor ID
- drs2412171972
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- hematological manifestations, Nepal, organ involvement, systemic lupus erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Patan Academy of Health SciencesUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted with diagnosis of systemic lupus erythematosus in medical ward of Patan Hospital.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Percentage of SLE patients with mucocutaneous involvement
Time frame: Through study completion from 2019 January to 2023 December.
Percentage of SLE patients with pericarditis
Time frame: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with respiratory involvement
Time frame: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with gastrointestinal involvement
Time frame: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with kidney involvement
Time frame: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with musculoskeletal involvement
Time frame: Through the study completion from 2019 January to 2023 December.
Percentage of SLE patients with neurological involvement
Time frame: Through the study completion from 2019 January to 2023 December.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Background: PubMed 31385462Aringer 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.
- Background: PubMed 17558704Beyan 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.
- Background: PubMed 23591169Paudyal BP, Gyawalee M. Clinical profile of patients with systemic lupus erythematosus. JNMA J Nepal Med Assoc. 2012 Jul-Sep;52(187):111-7.
- BackgroundTalukdar 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
- BackgroundGulati 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: PubMed 24861278Aleem A, Al Arfaj AS, khalil N, Alarfaj H. Haematological abnormalities in systemic lupus erythematosus. Acta Reumatol Port. 2014 Jul-Sep;39(3):236-41.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by Patan Academy of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with hematological abnormalities (time frame: Baseline at the time of hospital admission. (Cross-sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06936007, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.