NCT06768710

Brief Summary

the safety and validity of the PECARN with 100% sensitivity in both age groups in identifying patients with ciTBI and theoretically in reducing performed CT scans by 29%. Therefore, in patients classified in the low-risk category, it is a duty not to expose the child to ionizing radiation. the NICE criteria can minimize the number of CT scans conducted while maintaining a fair sensitivity for identifying patients with TBI and those requiring neurosurgical intervention the sensitivity of the intracranial damage NICE criteria was 93% for early presenters. This study is conducted to detect which guidelines can be followed to detect all intracranial lesions with minimizing the number of unnecessary CT scans. the aim of the study is to evaluate safety and efficacy (sensitivity and specificity) of PECARN and NICE guidelines for detection of traumatic brain injury as compared to current clinical practice in emergency setting and Detection of intracranial findings on CT brain and detection of lesions that need neurosurgical intervention. Significance of the study:

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

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

December 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 22, 2024

Last Update Submit

January 6, 2025

Conditions

Keywords

NICE GuidelinesPECARN Guidelines

Outcome Measures

Primary Outcomes (2)

  • the accuracy of PECARN guidelines

    evaluate the accuracy of PECARN guidelines for detection of traumatic brain injury

    30 day

  • the accuracy of NICE guidelines

    evaluate the accuracy of NICE guidelines for detection of traumatic brain injury

    30 day

Study Arms (1)

head trauma patients

patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice

You may qualify if:

  • All patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice.

You may not qualify if:

  • Patients unstable to had a CT scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Central Study Contacts

Noha Badran Abdelmougod, resident doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Emergency medicine, Sohag University

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 10, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

January 10, 2025

Record last verified: 2025-01