Prevalence, Risk Factors and Outcomes of Pediatric Vascular Thrombosis

July 15, 2023 updated by: Doaa Sayed Shaker Ahmed, Assiut University

Prevalence, Risk Factors and Outcomes of Vascular Thromboembolism in Children Attending Assuit University Hospital

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 .

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

15 infant aged from 1 day to 18 years with vascular thrombosis

Description

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 unit.

Exclusion Criteria :

  • Age more than 18 years.
  • Patient Known to have Sickle cell disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pediatrics with vascular thrombosis
Time Frame: 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
baseline
Number of risk factors of pediatric vascular thrombosis
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

June 3, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pediatric vascular thrombosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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