Hematological Abnormalities in Children

Hematological Abnormalities In Children With Congenital Cyanotic Heart Disease Attending Assiut University Hospitals: A Prospective Hospital- Based Study.

the aim of the study is to determine Hematological abnormalities in Congenital Cyanotic Heart Disease

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Diseases
• Intervention / Treatment: Diagnostic test: sampling

Detailed Description

Congenital heart defects are the most common developmental anomaly and are the commonest noninfectious causes of mortality in newborns; they affect up 1000 infants and in most cases the cause is unknown . Erythrocytosis, thrombocytopenia, platelets function defects, coagulation factors deficiencies are the main hematologic disorders in patients with cyanotic congenital heart disease .The hemorrhagic tendency was initially attributed to an increase in tissue vascularity, but co-existing hemostatic defects were subsequently identified and attributed to thrombocytopenia, shortened platelet survival, and deficient von Willebrand multimers .

In patients , platelets are shown to have both qualitative and quantitative abnormalities.However, there are conflicting data as regards the etiology of thrombocytopenia in congenital cyanotic heart disease . significant association has been reported between thrombocytopenia and a high hematocrit in cyanotic patients and multiple etiologies has been suggested including chronic compensated disseminated intravascular coagulation (DIC), reduce synthesis of clot factors and/or deranged platelet aggregation. Immature reticulated platelets represent the youngest platelets released into the circulation by regenerated marrow megakaryocyte and are the analogue of the red cell reticulocyte .The rate of platelet turnover can be evaluated by the relationship between the percent of reticulated platelets and the platelet count.

Erythrocytosis is an isolated increase in the number of red blood cells. Primary erythrocytosis is an increased red cell mass which surfaces in the absence of a definable stimulus, whereas secondary erythrocytosis refers to an isolated increase in the red cell mass in response to such stimulus as low systemic arterial oxygen saturation in the context of cyanotic congenital heart disease. Polycythemia could often be beneficial. Yet, it poses certain risks to the microcirculation. This is mainly because the capillary diameter is significantly smaller than the red cell diameter and this mismatch could cause viscosity

To increase at the capillary level. Patients with cyanotic heart disease may have an acceptable quality of life. However, they are invariably prone to several complications. For instance, hyperviscosity, hyperuricemia (mainly due to age-related impairment of uric acid excretion in adults), thrombocytopenia (decreased level of platelet production), blood clotting abnormalities (reduced synthesis of clotting factors and/or deranged platelet aggregation), cerebral abscess, cerebral embolism and endocarditis .

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: mamoud abdelshkour, master; Phone Number: 01140062035; Email: midoabdelshakour321@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All childern with Cyanotic Congenital heart disease admitted to the pediatric cardiology unit of Assiut University Hospitals over a period of one year

Description

Inclusion Criteria:

• All children.
• congenital cyanotic heart disease

Exclusion Criteria:

• other congenital heart disease.
• other congenital anomalies.
• other chronic disease.
• post-operative patient.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematological Abnormalities In ChilCongenital congenital Cyanotic Heart Disease	Determine hematological abnormality	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children with Congenital Cyanotic Heart Disease	To change morbidity and mortality, number of death in children with congenital cyanotic heart disease.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 20, 2023
• Primary Completion (Anticipated): November 20, 2023
• Study Completion (Anticipated): December 20, 2023

Study Registration Dates

• First Submitted: June 25, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: Hematological Abnormalities

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No