Anti Phospholipid Syndrome
Conditions
Keywords
AIHA
Brief summary
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_TESTHemoglobin
Blood sample
DIAGNOSTIC_TESTCoombs test
Blood sample
Sponsors
New Valley University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
APS patients will be divided into 2 arms based on the presence of AIHA AIHA defined by: * Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and * Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias. * Active hematologic malignancy causing hemolysis. * Composite incidence of VTE and arterial thrombosis in APS+AIHA vs APS without AIHA. * Frequency of triple aPL positivity in APS+AIHA vs APS-AIHA. * Prevalence of extra criteria manifestations. In hospital mortality, length of stay, and costs in AIHA hospitalizations with vs without APS.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of thrombotic events in APS patients with AIHA | baseline |
Secondary
| Measure | Time frame |
|---|---|
| Number of thrombotic events in APS patients aithout AIHA | baseline |
Countries
Egypt
Contacts
CONTACTAsmaa N Hussein, MD
Outcome results
None listed