Clinical trial NCT05840744: Evaluation of Risk Factors and Outcome of Thrombosis in Children
Official title: Evaluation of Risk Factors, Clinical Pattern and Outcome of Thrombosis in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombosis in Children
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: occurance of in-hospital mortality
timeFrame: 12 months
measure: Occurance of neurological deficit
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References: