New Complete Blood Count Parameters as Part of Diagnosis of Congenital Hereditary Spherocytosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 41
- 主要终点
- Diagnostic performance of mean reticulocyte volume (MRV)
研究概览
简要总结
This cross-sectional study aims to evaluate the diagnostic performance of selected automated complete blood count-derived erythrocytic and reticulocytic parameters in children with hereditary spherocytosis.
详细描述
Hereditary spherocytosis is an inherited red blood cell membrane disorder. Modern automated hematology analyzers provide additional erythrocytic and reticulocytic parameters that may aid in its recognition.
This observational study will include children with confirmed or clinically suspected hereditary spherocytosis and a comparison group without hereditary spherocytosis. Complete blood count and reticulocyte parameters including mean reticulocyte volume (MRV), immature reticulocyte fraction (IRF), Ret/IRF ratio, and MicroR will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 1 month to 18 years
- •Children with confirmed hereditary spherocytosis according to clinical and laboratory criteria, or age-appropriate children without evidence of hereditary spherocytosis
- •Availability of CBC and reticulocyte parameters
- •Written informed consent from parent or legal guardian
排除标准
- •Recent blood transfusion likely to influence red cell indices or reticulocyte parameters
- •Insufficient or unsuitable blood sample for automated analysis
- •Incomplete clinical or laboratory data required for classification
研究组 & 干预措施
Comparison Group
Age-appropriate children without evidence of hereditary spherocytosis.
Hereditary Spherocytosis
Children with confirmed hereditary spherocytosis.
结局指标
主要结局
Diagnostic performance of mean reticulocyte volume (MRV)
时间窗: Baseline
Sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of mean reticulocyte volume (MRV) for identifying hereditary spherocytosis.
次要结局
- Diagnostic performance of Ret/IRF ratio(Baseline)
- Diagnostic performance of immature reticulocyte fraction (IRF)(Baseline)
- Diagnostic performance of MicroR(Baseline)
- Mean hemoglobin level(Baseline)
- Mean MCHC(Baseline)
研究者
Mariaam Samir William Zakhary
Resident Physician, Department of Pediatrics
Assiut University