- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552703
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
- Name: Mohamed Ashraf
- Phone Number: +201050815922
- Email: Mohamed.20134268@med.au.edu.eg
Study Contact Backup
- Name: Mohamed Taghian, professor
- Phone Number: +201006876892
- Email: Mtaghyan@gmail.com
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
|
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
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
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Epidural, Cranial
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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