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Recruiting Not applicable

Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study

NCT07757789 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-07-01
Last updated
2026-08-11

Condition(s) studied

Antiphospholipid Syndrome

Investigational drug(s) / intervention(s)

Platelet count

Platelet 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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • All-cause mortality — From date of diagnosis until the date of death from any cause,assessed up to 5 years"

Trial sites (1)

FacilityCityRegionStatus
New Valley University Al Khārjah Kharga Oasis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07757789 on ClinicalTrials.gov ↗ ← All trials in Egypt