Thrombocytopenia Trajectories in antiphospholipid syndrome
Official title: Thrombocytopenia Trajectories as a Dynamic Biomarker of Clinical Severity and Survival in Antiphospholipid Syndrome: A Multicenter Cohort Study
Run by New Valley University · NCT07757789 · Data updated 2026-11-12
This study tests whether patterns in platelet counts over time can predict outcomes for adults with antiphospholipid syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | New Valley University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Al Khārjah, Kharga Oasis) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | September 25, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07757789 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with definite APS by Sydney criteria and persistent aPL positivity, and at least 3 documented platelet counts over 12 months prior to enrollment.
✕Probably not a fit
Patients with thrombocytopenia due to non-APS causes or with conditions expected to independently drive survival may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter cohort study examines how different longitudinal platelet trajectories relate to clinical severity and survival in adults with definite APS. Researchers will model platelet count patterns (persistent, intermittent, transient, or absent thrombocytopenia) using data from at least 3 counts over 12 months. The goal is to determine if these trajectories provide prognostic information beyond baseline thrombocytopenia and to identify high-risk patient subgroups. The study does not involve a non-standard intervention beyond collecting and analyzing existing platelet data. Participation is limited to patients meeting Sydney criteria for APS and with persistent aPL positivity, treated at the participating center(s).
Why it matters
Potential benefit: If trajectories prove predictive, clinicians could better estimate prognosis and tailor monitoring and therapies for APS patients with thrombocytopenia.
How similar studies have gone: Previous work has linked thrombocytopenia to worse outcomes in APS, but this study is novel in analyzing longitudinal platelet trajectories rather than static levels.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
New Valley University
Al Khārjah, Kharga Oasis, Egypt Recruiting
Study contacts
- Study coordinator: Asmaa N Hussein, MD
- Email: asmaanady_1010@med.nvu.edu.eg
- Phone: 01065161752
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.