Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Number of thrombotic events in APS patients with AIHA
研究概览
简要总结
AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity. APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL).
详细描述
AIHA occurs in ~10-12% of APS cohorts and is associated with arterial thrombosis, cardiac valve disease, livedo reticularis, epilepsy/chorea, and a more severe APS phenotype.
APS patients hospitalized with AIHA have markedly higher venous thromboembolism (VTE) risk (OR ≈ 8.6) compared with AIHA without APS.
Hematologic APS (AIHA ± thrombocytopenia) may precede or coexist with thrombotic/obstetric APS, depending on aPL profile.
There is a need to systematically define the clinical implications (thrombosis, organ involvement, outcomes) of AIHA in APS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Adults aged ≥18 years
- •Patients with anemia consistant with hemolysis.
- •Patient diagnosed with antiphospholipid syndrome.
- •Informed consent obtained
排除标准
- •Age less than 18 years.
- •Other causes of anemia than autoimmune hemolysis.
研究组 & 干预措施
Antiphospholipid syndrome patients with AIHA
AIHA defined by:
- Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and
- Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias.
干预措施: Coombs test (Diagnostic Test)
Antiphospholipid syndrome patients without AIHA
Patients without hemolysis evidence
干预措施: Coombs test (Diagnostic Test)
Antiphospholipid syndrome patients with AIHA
AIHA defined by:
- Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and
- Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias.
干预措施: Hemoglobin (Diagnostic Test)
Antiphospholipid syndrome patients without AIHA
Patients without hemolysis evidence
干预措施: Hemoglobin (Diagnostic Test)
结局指标
主要结局
Number of thrombotic events in APS patients with AIHA
时间窗: baseline
次要结局
- Number of thrombotic events in APS patients aithout AIHA(baseline)
研究者
Asmaa Nady Hussein
Lecturer of Internal Medicine
New Valley University