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临床试验/NCT02887118
NCT02887118终止不适用

Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
82
试验地点
1
主要终点
number of dense red blood cells (DRBC)

研究概览

简要总结

Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.

详细描述

An association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia.

This factor has not been studied in children. The identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, Dactylitis) would be useful for optimal care of the children and early intensification Red blood cell density might be one of these prognostic factors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 months-18 years
  • Patient with sickle cell disease namely SS, or S / Beta0 or S / Beta +
  • Patient regularly followed in the pediatric cohort of the CHI Creteil
  • Patient Hospitalized for an annual check-up
  • With or without intensification by Hydroxycarbamide
  • patient who haven't been transfused within 3 months
  • Whose parents have given their informed consent
  • Patients insured to the French social scheme

排除标准

  • Sickle cell SC disease
  • Having received an allogeneic bone marrow transplantation
  • Under regular transfusion program
  • Having received a transfusion within 3 months

结局指标

主要结局

number of dense red blood cells (DRBC)

时间窗: 1 day

Evaluation of the number of dense red blood cells in the blood of affected children

次要结局

  • biological profile(1 day)
  • Number of patients with velocities > 200 cm/sec on transcranial doppler(1 day)
  • Number of patients with history of acute splenic sequestration,(1 day)
  • Number of patients with history of acute chest syndrome(1 day)
  • Number of patients with History of dactylitis(1 day)
  • Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)(1 day)
  • Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)(1 day)
  • Number of patients with hydroxycarbamide treatment(1 day)
  • Number of dense red blood cells(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Corinne Pondarré

Doctor

Centre Hospitalier Intercommunal Creteil

研究点 (1)

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