New CBC Parameters in Diagnosis of Hereditary Spherocytosis

N/ANot Yet RecruitingNCT07842718

Assiut University41 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hereditary Spherocytosis Hemolytic Anemia

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Diagnostic performance of mean reticulocyte volume (MRV)

Sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of mean reticulocyte volume (MRV) for identifying hereditary spherocytosis.

Time frame: Baseline

Secondary Outcomes

Diagnostic performance of Ret/IRF ratio

Sensitivity, specificity, and area under the ROC curve of the reticulocyte/IRF ratio for identifying hereditary spherocytosis.

Time frame: Baseline

Diagnostic performance of immature reticulocyte fraction (IRF)

Sensitivity, specificity, and area under the ROC curve of immature reticulocyte fraction for identifying hereditary spherocytosis.

Time frame: Baseline

Diagnostic performance of MicroR

Sensitivity, specificity, and area under the ROC curve of percentage of microcytic red cells (MicroR) for identifying hereditary spherocytosis.

Time frame: Baseline

Mean hemoglobin level

Mean hemoglobin concentration in g/dL compared between hereditary spherocytosis and non-hereditary spherocytosis groups.

Time frame: Baseline

Mean MCHC

Mean corpuscular hemoglobin concentration compared between groups.

Time frame: Baseline

Central Contacts

Mariaam S William, Resident

CONTACT

+20 10 24556619 Mariam.18313400@med.aun.edu.eg

Data from ClinicalTrials.gov

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