NCT05840744

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2024

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 12, 2023

Last Update Submit

April 30, 2023

Conditions

Thrombosis in Children

Outcome Measures

Primary Outcomes (2)

  • occurance of in-hospital mortality

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

    12 months

  • Occurance of neurological deficit

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

    12 months

Interventions

complete blood countDIAGNOSTIC_TEST

Investigations done for identifying the risk factor which lead to thrombosis.

Also known as: blood culture, CRP, Anti thrombin 3 if thrombophilia suspected

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may not qualify if:

  • Persons above 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

MeSH Terms

Interventions

Blood Cell CountBlood Culture

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaMicrobiological Techniques

Central Study Contacts

haidy A youssef, Resident

CONTACT

01019464292haidyabdelazim@med.sohag.edu.eg

alzahraa alsayed ahmed sharaf A ahmed, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of pediatric and neonatology department, Sohag University Hospitals

Study Record Dates

First Submitted

April 12, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

April 13, 2024

Study Completion

April 13, 2024

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

EG(1)