An interventional study of Platelet count in Antiphospholipid Syndrome, sponsored by New Valley University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by New Valley University · Not applicable, Interventional, and Diagnostic
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.
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.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 52 are open to participants now.
This study's planned enrollment of 200 is above the median of 41 across 65 interventional studies indexed under Antiphospholipid Syndrome.
Browse Antiphospholipid Syndrome studies →New Valley University is the lead sponsor of 25 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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)
Diagnostic Test: 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. Intermittent/fluctuating thrombocytopenia 3. Persistent thrombocytopenia (less than 150×10⁹/L)
All-cause mortality
Time frame: From date of diagnosis until the date of death from any cause,assessed up to 5 years"
number recurrent thrombotic event
Time frame: Through study completion, an average of 5 years.
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Sep 2027, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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New Valley University