Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- New Valley University
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Number of thrombotic events in APS patients with AIHA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Antiphospholipid syndrome patients with 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.
Intervention: Coombs test (Diagnostic Test)
Antiphospholipid syndrome patients without AIHA
Patients without hemolysis evidence
Intervention: Coombs test (Diagnostic Test)
Antiphospholipid syndrome patients with 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.
Intervention: Hemoglobin (Diagnostic Test)
Antiphospholipid syndrome patients without AIHA
Patients without hemolysis evidence
Intervention: Hemoglobin (Diagnostic Test)
Outcomes
Primary Outcomes
Number of thrombotic events in APS patients with AIHA
Time Frame: baseline
Secondary Outcomes
- Number of thrombotic events in APS patients aithout AIHA(baseline)
Investigators
Asmaa Nady Hussein
Lecturer of Internal Medicine
New Valley University