Antiphospholipid Syndrome
Conditions
Keywords
thrombocytopenia
Brief summary
Thrombocytopenia is common in antiphospholipid syndrome (APS) and is now included in the 2023 ACR/EULAR APS criteria as an important non criteria/hematologic feature. Persistent or low-moderate thrombocytopenia independently predicts reduced long-term survival in APS, with hazard ratios for mortality around 2.7-4.4, and is associated with a severe disease phenotype and thrombotic deaths.
Detailed description
Thrombocytopenia also independently predicts recurrent thrombosis, pregnancy morbidity, and severe extra criteria events in primary APS, correlates with higher damage indices and thrombotic/neurological involvement, and is enriched in high-risk thrombotic APS clusters with poorer prognosis. Existing studies treat thrombocytopenia as a static exposure (present/absent, baseline level). The prognostic value of longitudinal platelet trajectories (persistent vs intermittent vs transient vs absent thrombocytopenia) for global clinical severity and survival has not been systematically evaluated.
Interventions
DIAGNOSTIC_TESTPlatelet count
Longitudinal platelet counts (routine visits, hospitalizations) will be extracted. • Using group based trajectory modeling or latent class mixed models, patients will be assigned to data driven platelet trajectory classes, anticipated as: 1. Stable normal (no thrombocytopenia) 2. Transient thrombocytopenia (recovery to normal) 3. Intermittent/fluctuating thrombocytopenia 4. Persistent mild-moderate thrombocytopenia (e.g., 50-149×10⁹/L) 5. Persistent severe thrombocytopenia (\<50×10⁹/L)
Sponsors
New Valley University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Definite APS by Sydney criteria (thrombotic and/or obstetric) with persistent aPL positivity. * ≥3 documented platelet counts over ≥12 months before inclusion (to allow trajectory modeling)
Exclusion criteria
* Thrombocytopenia clearly attributable to non APS causes (e.g., chemotherapy, myelodysplastic syndromes, cirrhosis, HIV). * Concomitant conditions strongly affecting survival independent of APS (e.g., metastatic cancer), at investigator discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | From date of diagnosis until the date of death from any cause,assessed up to 5 years" |
Secondary
| Measure | Time frame |
|---|---|
| number recurrent thrombotic event | Through study completion, an average of 5 years. |
Countries
Egypt
Contacts
CONTACTAsmaa N Hussein, MD
Outcome results
None listed