Traumatic Extradural Hematoma in Paediatric Age Group

September 21, 2022 updated by: Mohamed Ashraf Salah, Assiut University
The aim of this study is to assess the clinical and radiological characteristics of children with traumatic extradural hematoma and factors affecting the initial neurological status and outcome.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Extradural hematoma (EDH) represents 2.7-4% of traumatic brain injury .EDH is a potentially lethal condition which is easily cured if diagnosed early .EDH is less frequent in pediatric age group than in adults. The mean age of pediatric patients harboring EDH is between 6 and 10 years and it is rare among infants under the age of 12 months. EDH in children differs significantly from adults in terms of mode of injury, prognostic factors, and outcome. EDH in children may follow a trivial trauma and the course is more insidious and associated skull fractures is less frequent and these factors make it difficult to diagnose and often challenging to manage. The reported rate of mortality from EDH in children is varying from 0% and 17%, The criteria for choosing the surgical evacuation Vs. conservative management in pediatric age group still ill-defined this is what encouraged the investigators to carry this study to present our experience in the management of EDH in children aged less than 18 years.

Study Type

Observational

Enrollment (Anticipated)

111

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

Study Contact Backup

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

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.

Description

Inclusion Criteria:

  • All pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.

Exclusion Criteria:

  • Patients aged more than 18 years old.
  • patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glascow outcome scale
Time Frame: immediately after the intervention/procedure/surgery

The Glasgow Outcome Scale (GOS) categorizes the outcomes of patients after traumatic brain injury, as follows

  1. Persistent vegetative state: Minimal responsiveness
  2. Severe disability: Conscious but disabled; dependent on others for daily support
  3. Moderate disability: Disabled but independent; can work in sheltered setting
  4. Good recovery: Resumption of normal life despite minor deficits
immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
patients who died after surgery
immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
morbidity
Time Frame: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
patients with disability after surgery
immediately after the intervention/procedure/surgery, through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDH in paediatric

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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