Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
August 5, 2026 updated by: Asmaa Nady Hussein, New Valley University
AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity.
APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
AIHA occurs in ~10-12% of APS cohorts and is associated with arterial thrombosis, cardiac valve disease, livedo reticularis, epilepsy/chorea, and a more severe APS phenotype.
APS patients hospitalized with AIHA have markedly higher venous thromboembolism (VTE) risk (OR ≈ 8.6) compared with AIHA without APS.
Hematologic APS (AIHA ± thrombocytopenia) may precede or coexist with thrombotic/obstetric APS, depending on aPL profile.
There is a need to systematically define the clinical implications (thrombosis, organ involvement, outcomes) of AIHA in APS.
Study Type
Interventional
Enrollment (Estimated)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Asmaa N Hussein, MD
- Phone Number: 01065161752
- Email: asmaanady_1010@med.nvu.edu.eg
Study Locations
-
-
Kharga Oasis
-
Al Khārjah, Kharga Oasis, Egypt, 72511
- Recruiting
- New Valley University
-
Contact:
- Asmaa N Hussein, MD
- Phone Number: 01065161752
- Email: asmaanady_1010@med.nvu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Patients with anemia consistant with hemolysis.
- Patient diagnosed with antiphospholipid syndrome.
- Informed consent obtained
Exclusion Criteria:
- Age less than 18 years.
- Other causes of anemia than autoimmune hemolysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Antiphospholipid syndrome patients with AIHA
AIHA defined by:
|
Blood sample
Blood sample
|
|
Active Comparator: Antiphospholipid syndrome patients without AIHA
Patients without hemolysis evidence
|
Blood sample
Blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of thrombotic events in APS patients with AIHA
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of thrombotic events in APS patients aithout AIHA
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mulder FVM, Evers D, de Haas M, Cruijsen MJ, Bernelot Moens SJ, Barcellini W, Fattizzo B, Vos JMI. Severe autoimmune hemolytic anemia; epidemiology, clinical management, outcomes and knowledge gaps. Front Immunol. 2023 Sep 18;14:1228142. doi: 10.3389/fimmu.2023.1228142. eCollection 2023.
- Zufferey R, Dull T, Mandel RJ, Bukovsky A, Quiroz D, Naldini L, Trono D. Self-inactivating lentivirus vector for safe and efficient in vivo gene delivery. J Virol. 1998 Dec;72(12):9873-80. doi: 10.1128/JVI.72.12.9873-9880.1998.
- Erton ZB, Leaf RK, de Andrade D, Clarke A, Tektonidou MG, Pengo V, Sciascia S, Pardos-Gea J, Kello N, Paredes-Ruiz D, Lopez-Pedrera C, Belmont HM, Fortin PR, Ramires de Jesus G, Atsumi T, Zhang Z, Efthymiou M, Branch DW, Pazzola G, Andreoli L, Duarte-Garcia A, Rodriguez-Almaraz E, Petri M, Cervera R, Artim-Esen B, Quintana R, Shi H, Zuo Y, Willis R, Barber MRW, Skeith L, Radin M, Meroni P, Bertolaccini ML, Cohen H, Roubey R, Erkan D. Thrombocytopenia and autoimmune hemolytic anemia in antiphospholipid antibody-positive patients: Descriptive analysis of the AntiPhospholipid syndrome alliance for clinical trials and InternatiOnal networking (APS ACTION) clinical database and repository ("Registry"). Lupus. 2025 May;34(6):617-625. doi: 10.1177/09612033251332258. Epub 2025 Apr 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2026
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
April 15, 2028
Study Registration Dates
First Submitted
July 29, 2026
First Submitted That Met QC Criteria
July 29, 2026
First Posted (Actual)
August 3, 2026
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 5, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIHA-APS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.