Hematological Abnormalities in Children

Hematologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05541835
• Other study ID #: Hematological Abnormalities
• Status: Not yet recruiting
• Start date: March 20, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: mamoud abdelshkour, master
• Phone: 01140062035
• Email: midoabdelshakour321[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• All children.

• congenital cyanotic heart disease

Exclusion Criteria:

• other congenital heart disease.

• other congenital anomalies.

• other chronic disease.

• post-operative patient.

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Diagnostic Test:
• sampling
venous sampling of patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematological Abnormalities In ChilCongenital congenital Cyanotic Heart Disease	Determine hematological abnormality	Baseline
Secondary	Children with Congenital Cyanotic Heart Disease	To change morbidity and mortality, number of death in children with congenital cyanotic heart disease.	Baseline