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临床试验/NCT02855957
NCT02855957已完成不适用

Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
2
主要终点
Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene

研究概览

简要总结

Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene

时间窗: Day 1

次要结局

  • Correlation between the pool of free α-Hb and Mean Cell Volume(Day 1)
  • Correlation between the pool of free α-Hb and percent of reticulocytes(Day 1)
  • Correlation between the pool of free α-Hb and Mean Corpuscular Hb(Day 1)
  • Correlation between the pool of free α-Hb and Hb value(Day 1)
  • Correlation between the pool of free α-Hb and fetal Hb(Day 1)
  • Correlation between the pool of free α-Hb and erythrocyte enzymes(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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