Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Overall coagulation activity
研究概览
简要总结
Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level > 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8 years or older
- •Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C
- •Patient covered by a social security or equivalent health insurance plan
- •Collection of the non-opposition for adults
- •Information of the minor and collection of the non-opposition from both parents
排除标准
- •Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion
- •Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator's discretion)
- •Patient under guardianship, curatorship, or legal protection
- •Patient subject to a legal protection measure
- •Person admitted to a health or social care institution for purposes other than research
结局指标
主要结局
Overall coagulation activity
时间窗: Baseline
To compare the overall coagulation activity (measurement of in vitro clot formation by rotary thromboelastometry (ROTEM)) between sickle cell patients with a severe haemolytic phenotype and those with a less severe haemolytic phenotype.
次要结局
未报告次要终点