- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07696598
Extradural Hematoma in Pediatrics After Acute Head Injury: Surgical and Clinical Outcome
July 6, 2026 updated by: Abdelrahman Mohamed, Sohag University
A Combined Retrospective and Prospective Study of Surgical and Clinical Outcomes in Pediatric Patients With Extradural Hematoma Following Acute Head Injury
Acute extradural hematoma (EDH) is a potentially life-threatening neurosurgical emergency in children, commonly resulting from traumatic head injury.
Early diagnosis and timely surgical intervention are critical factors influencing neurological recovery and overall outcome.
Despite advances in neuroimaging and surgical techniques, the clinical presentation, management strategies, and outcomes of pediatric EDH remain variable
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
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: abdelrahman mohamed neurosurgery department of sohag university, resident
- Phone Number: 01021293440
- Email: abduabdelaala@gmail.com
Study Locations
-
-
Sohag Governorate
-
Sohag, Sohag Governorate, Egypt
- Recruiting
- Sohag University Faculty of Medicine
-
-
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
Yes
Sampling Method
Probability Sample
Study Population
Pediatric patients aged 0-18 years with acute traumatic extradural hematoma following head injury who are treated surgically at the participating neurosurgical center.
Description
Inclusion Criteria:
- Pediatric patients (<18 years of age).
- Patients with traumatic extradural (epidural) hematoma.
- Patients who underwent surgical evacuation of the extradural hematoma.
Exclusion Criteria:
- Patients with coagulopathy.
- Patients with autoimmune disorders.
- Patients with a previous operation for extradural hematoma.
- Patients with associated intracranial hematomas (e.g., subdural hematoma, subarachnoid hemorrhage, or brain contusion).
- Patients with panfacial fractures.
- Patients with significant general surgical, cardiothoracic, or orthopedic comorbidit.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
surgical evacuation
Pediatric patients with acute extradural hematoma undergoing surgical evacuation.
|
emergency craniotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurological outcome assessed by the King's Outcome Scale for Childhood Head Injury (KOSCHI)
Time Frame: 3-6 month after surgery
|
Neurological outcome measured using the King's Outcome Scale for Childhood Head Injury (KOSCHI).
Scores range from 1 to 5A/5B according to the scale.
Higher scores indicate better neurological recovery.
|
3-6 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 20, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
June 26, 2026
First Submitted That Met QC Criteria
July 6, 2026
First Posted (Actual)
July 10, 2026
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 6, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-26-6-16MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
reuse of data for proposes that had not been approved by paticipants
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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