Evaluation of Risk Factors and Outcome of Thrombosis in Children

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05840744
Collaborator
(none)
30
1
11.4
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Risk Factors, Clinical Pattern and Outcome of Thrombosis in Children
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 13, 2024
Anticipated Study Completion Date :
Apr 13, 2024

Outcome Measures

Primary Outcome Measures

  1. occurance of in-hospital mortality [12 months]

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

  2. Occurance of neurological deficit [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

-

Exclusion Criteria:
  • • Persons above 18 years old.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University hospitals Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haidy Abdelazim Youssif, Resident of pediatric and neonatology department, Sohag University Hospitals, Sohag University
ClinicalTrials.gov Identifier:
NCT05840744
Other Study ID Numbers:
  • Soh-Med-23-04-17MS
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023