Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemoglobin, Coombs test.
- Who it may be relevant to
- Registry conditions: Anti Phospholipid Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
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.
Interventions
- Diagnostic test Hemoglobin
Blood sample - Diagnostic test Coombs test
Blood sample
Primary outcome measures
- Number of thrombotic events in APS patients with AIHA [Time frame: baseline]
Secondary outcome measures (1)
- Number of thrombotic events in APS patients aithout AIHA [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Egypt · 1 center
- New Valley University — Al Khārjah
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. PMID 37795092
- 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. PMID 9811723
- 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, Bertola PMID 40180601
Identifiers
NCT: NCT07743242 · AIHA-APS