Extradural Hematoma in Pediatrics After Acute Head Injury... | NCT07696598

Studies
Extradural Hematoma in Pediatrics After Acute Head Injury: Surgical and Clinical Outcome

NCT07696598

Sponsor

Sohag University

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Pediatric Traumatic Brain Injury

Interventions

evacuation of hematoma

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2026Estimated

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Apr 1, 2027Estimated

First Submitted Date

Jun 26, 2026

First Submission Date that Met QC Criteria

Jul 6, 2026

First Posted Date

Jul 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. Despite advances in neuroimaging and surgical techniques, the clinical presentation, management strategies, and outcomes of pediatric EDH remain variable

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical evacuation		Pediatric patients with acute extradural hematoma undergoing surgical evacuation.	Procedure: evacuation of hematoma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
evacuation of hematoma	Procedure	emergency craniotomy	surgical evacuation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3-6 month after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abdelrahman mohamed neurosurgery department of sohag university, resident	Contact	01021293440		abduabdelaala@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Faculty of Medicine	Recruiting	Sohag	Sohag Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

reuse of data for proposes that had not been approved by paticipants

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided