Pediatric Traumatic Brain InjuryNCT07696598
Extradural Hematoma in Pediatrics After Acute Head Injury: Surgical and Clinical Outcome
An observational study of Pediatric Traumatic Brain Injury, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Traumatic Brain Injury
- What is being tested?
- evacuation of hematoma
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Pediatric patients (<18 years of age).
- Patients with traumatic extradural (epidural) hematoma.
- Patients who underwent surgical evacuation of the extradural hematoma.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
abdelrahman mohamed neurosurgery department of sohag university, resident contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Faculty of Medicine
Sohag, Sohag Governorate
About this study
Official title: 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
- Conditions
- Pediatric Traumatic Brain Injury
- Being tested
- evacuation of hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evacuation of hematomaProcedure or surgery
emergency craniotomy
| Study group | Role | What they receive |
|---|---|---|
| surgical evacuation | Pediatric patients with acute extradural hematoma undergoing surgical evacuation. Receives: Procedure: evacuation of hematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome assessed by the King's Outcome Scale for Childhood Head Injury (KOSCHI)
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.
Measured: 3-6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start20 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696598
- Sponsor's protocol ID
- Soh-Med-26-6-16MS
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: reuse of data for proposes that had not been approved by paticipants
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Retrospective and Prospective Study of Surgical and Clinical Outcomes in Pediatric Patients With Extradural Hematoma Following Acute Head Injury
- ClinicalTrials.gov ID
- NCT07696598
- Acronym / sponsor ID
- Soh-Med-26-6-16MS
- Conditions
- Pediatric Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical evacuation | – | Procedure: evacuation of hematomaPediatric patients with acute extradural hematoma undergoing surgical evacuation. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Pediatric patients (<18 years of age).
- Patients with traumatic extradural (epidural) hematoma.
- Patients who underwent surgical evacuation of the extradural hematoma.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evacuation of hematomaemergency craniotomy | Procedure or surgery | surgical evacuation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided. reuse of data for proposes that had not been approved by paticipants
Related trials for Pediatric Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
abdelrahman mohamed neurosurgery department of sohag university, resident contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Traumatic Brain Injury, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact abdelrahman mohamed neurosurgery department of sohag university, resident (01021293440, abduabdelaala@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome assessed by the King's Outcome Scale for Childhood Head Injury (KOSCHI) (time frame: 3-6 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.