Evaluation of Risk Factors and Outcome of Thrombosis in Children

Evaluation of Risk Factors, Clinical Pattern and Outcome of Thrombosis in Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombosis in Children
• Intervention / Treatment: Diagnostic test: complete blood count

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%.

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

Contacts and Locations

• Study Contact: Name: haidy A youssef, Resident; Phone Number: 01019464292; Email: haidyabdelazim@med.sohag.edu.eg
• Study Contact Backup: Name: alzahraa alsayed ahmed sharaf A ahmed, Professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• All children age from one day to 18 yrs presented with any vascular thrombosis decomented by clinical picture and venous doppler study or radiological study.

Description

Inclusion Criteria:• All children age from one day to 18 yrs presented with any vascular thrombosis decomented by clinical picture and venous doppler study or radiological study.

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Exclusion Criteria:

• • Persons above 18 years old.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurance of in-hospital mortality	detection the mortality occurance in patients with thrombosis within admission in hospital	12 months
Occurance of neurological deficit	occurance of neurological deficit at the end of hospital admission and before discharge.	12 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): April 13, 2024
• Study Completion (Anticipated): April 13, 2024

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 30, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Hemostatics; Coagulants; Thrombin; Antithrombins
• Other Study ID Numbers: Soh-Med-23-04-17MS

Drug and device information, study documents

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