Evaluation of Risk Factors and Outcome of Thrombosis in Children

NCT ID: NCT05840744

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-04-13

Brief Summary

Pediatric thrombosis is multifactorial, and usually risk factors either congenital or acquired are present.

Patient may has one risk factor or more such as sepsis, cancers, congenital heart disease, post surgery , central venous catheter insertion, nephrotic syndrome, systemic lupus erythromatosis and inflammatory bowel disease.

If there's no obvious risk factor for thrombosis, hereditary thrombophilia is suspected which results when an inherited factor, such as antithrombin , protein C or protein S deficiency.

Detailed Description

Thrombosis is the formation of a blood clot (partial or complete blockage) within blood vessels, whether venous or arterial, limiting the natural flow of blood and resulting in clinical sequela.

Incidence of childhood thrombosis is 0.07-0.14/10,000 in the general population. This incidence has been reported to be 5.3/10,000 in children presenting to hospital, 0.51/10,000 in all newborns and 0.24/10,000 in children in neonatal intensive care units . Pediatric thrombosis is multifactorial, and usually risk factors either congenital or acquired are present. . Patient may has one risk factor or more such as sepsis, cancers, congenital heart disease, post surgery , central venous catheter insertion, nephrotic syndrome, systemic lupus erythromatosis and inflammatory bowel disease. If there's no obvious risk factor for thrombosis, hereditary thrombophilia is suspected which results when an inherited factor, such as antithrombin , protein C or protein S deficiency.

There are three changes described by Virchow in 1856 are involved in the formation of thrombosis:

1. Changes in blood flow (rheology, stasis)

2. Changes in the vascular wall

3. Changes in the blood levels of coagulation factors The diagnosis of thrombosis is made more frequently and more easily in children due to noninvasive diagnos-tic methods [Doppler and ultrasonography (US), echo-cardiography, computed tomography (CT) and magnet-ic resonance imaging (MRI)]. The morbidity and mortality rates are high, although it occurs more rarely compared with adult thrombosis and does not develop in the absence of a triggering factor; the rate of mortality related with direct venous thromboembolism is 2.2%, the frequency of post-thrombotic syndrome is 12.4%, and the recurrence rate for thrombosis is 8.1%.

Conditions

Thrombosis in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

complete blood count

Investigations done for identifying the risk factor which lead to thrombosis.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

blood culture; CRP; Anti thrombin 3 if thrombophilia suspected

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• • Persons above 18 years old.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Haidy Abdelazim Youssif

Resident of pediatric and neonatology department, Sohag University Hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University hospitals

Sohag, , Egypt

Countries

Egypt

Central Contacts

haidy A youssef, Resident

Role: CONTACT

haidyabdelazim@med.sohag.edu.eg

01019464292

alzahraa alsayed ahmed sharaf A ahmed, Professor

Role: CONTACT

Facility Contacts

Magdy M Amin, Professor

Role: primary

Other Identifiers

Soh-Med-23-04-17MS

Identifier Type: -

Identifier Source: org_study_id