Thrombocytopenia Trajectories as a Dynamic Biomarker of Clinical Severity and Survival in Antiphospholipid Syndrome: A Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Antiphospholipid syndrome patients
- 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)
干预措施: Platelet count (Diagnostic Test)
结局指标
主要结局
All-cause mortality
时间窗: From date of diagnosis until the date of death from any cause,assessed up to 5 years"
次要结局
- number recurrent thrombotic event(Through study completion, an average of 5 years.)
研究者
Asmaa Nady Hussein
Lecturer of Internal Medicine
New Valley University