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临床试验/NCT05840744
NCT05840744尚未招募不适用

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

Sohag University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
occurance of in-hospital mortality

研究概览

简要总结

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.

详细描述

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%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • • Persons above 18 years old.

结局指标

主要结局

occurance of in-hospital mortality

时间窗: 12 months

detection the mortality occurance in patients with thrombosis within admission in hospital

Occurance of neurological deficit

时间窗: 12 months

occurance of neurological deficit at the end of hospital admission and before discharge.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haidy Abdelazim Youssif

Resident of pediatric and neonatology department, Sohag University Hospitals

Sohag University

研究点 (1)

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