Prevalence, Risk Factors and Outcomes of Pediatric Vascular Thrombosis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05889897
Collaborator
(none)
15
12

Study Details

Study Description

Brief Summary

This study is aimed to identify the prevalence, risk factors and outcomes of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thrombosis is a blood clot that develops within veins or sometimes arteries in the body.

    Occur most commonly in the inferior and superior vena cava, their major tributaries, the deep veins of the extremities, the splanchnic veins, as well as the cerebral venous sinuses.

    The incidence of venous thromboembolism (VTE) increases with age. In the pediatric population (0-18 years) the incidence is approximately 0.7-2.1 cases per 100,000 children,1-3 while in the adult population the incidence is 100-150 per 100,000.4

    Risk factors include the presence of central venous lines, trauma, major surgery followed by bedrest, immobilization, infection (cellulitis, osteomyelitis, phlebitis), cancer chemotherapy, inflammatory bowel disease, nephrotic syndrome, obesity, dehydration, and total parenteral nutrition.

    Patients with vascular thromboembolism present with various symptoms depending on site of thrombosis , symptoms include swelling, redness, pain , low-grade fever In cases that develop pulmonary embolism they experience chest pain and shortness of breath that begin suddenly

    Diagnosis of vascular thromboembolism include combination of signs and symptoms together with laboratory investigations that include routine lab investigations, D-dimer , protein s , protein C and antithrombin lll also imaging studies as Doppler US , MSCT with angiography and MRV

    Vascular thrombosis mainly treated with anticoagulant therapy with subcutaneous injection of low molecular weight heparin These medications prevent the clot from growing and decrease the risk of its breaking apart and causing further complications Other treatments may include wearing compression stockings and applying warm packs to improve blood flow and pain caused by the clot

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prevalence, Risk Factors and Outcomes of Vascular Thromboembolism in Children Attending Assuit University Hospital
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of pediatrics with vascular thrombosis [baseline]

      This study is aimed to identify the prevalence of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications

    2. Number of risk factors of pediatric vascular thrombosis [Baseline]

      This study is aimed to identify risk factors of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Age : From 1day to 18 years Sex : Both genders Confirmed diagnosed cases, either Symptomatic or asymptomatic venous and arterial thromboembolism established by an imaging study All patients admitted to the different units of children hospital including surgical unite.
    Exclusion Criteria:
    • 1-Age more than 18 years 2-Patient Known to have Sickle cell disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Maher Mokhtar, Prof, Assiut University
    • Principal Investigator: Mervat Amin, Assist Prof, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Doaa Sayed Shaker Ahmed, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05889897
    Other Study ID Numbers:
    • pediatric vascular thrombosis
    First Posted:
    Jun 5, 2023
    Last Update Posted:
    Jun 5, 2023
    Last Verified:
    Jun 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 5, 2023