Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07757789

Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Valley University

Al Khārjah, Kharga Oasis, 72511, Egypt

Location status: Recruiting

Location contact

Asmaa N Hussein, MD

CONTACT

[email protected]

01065161752

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet count

Diagnostic Test

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:
  • Stable normal (no thrombocytopenia)
  • Transient thrombocytopenia (recovery to normal)
  • Intermittent/fluctuating thrombocytopenia
  • Persistent mild-moderate thrombocytopenia (e.g., 50-149×10⁹/L)
  • Persistent severe thrombocytopenia (<50×10⁹/L)

Primary outcomes

  1. All-cause mortality

    Time frame: From date of diagnosis until the date of death from any cause,assessed up to 5 years"

Secondary outcomes

  1. number recurrent thrombotic event

    Time frame: Through study completion, an average of 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa N Hussein, MD

CONTACT

[email protected]

01065161752

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Official study title

Thrombocytopenia Trajectories as a Dynamic Biomarker of Clinical Severity and Survival in Antiphospholipid Syndrome: A Multicenter Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.