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Status unknownNCT05552703Updated Sep 23, 2022

Traumatic Extradural Hematoma in Paediatric Age Group

An observational study in Extradural Hematoma, sponsored by Assiut University. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
Up to 18 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Extradural Hematoma

Keywords

  • paediatrics
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In context

Hematoma, Epidural, Spinal

20 studies on the registry are indexed under Hematoma, Epidural, Spinal; 5 are open to participants now.

Browse Hematoma, Epidural, Spinal studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (estimated)
Patient registry
No

Interventions

  • Proceduresurgical evacuation of extradural hematoma

    evacuation of extradural hematoma by craniotomy

06

What researchers measure

Primary outcomes

  1. glascow outcome scale

    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

    Time frame: immediately after the intervention/procedure/surgery

Secondary outcomes

  1. mortality

    patients who died after surgery

    Time frame: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year

  2. morbidity

    patients with disability after surgery

    Time frame: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2022; primary completion for Nov 2022, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2021
First posted
Sep 23, 2022
StartEst.
Oct 1, 2022
Primary completionEst.
Nov 30, 2022
CompletionEst.
Dec 30, 2022
Last update
Sep 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05552703
Lead sponsor
Assiut University
Responsible party
Mohamed Ashraf Salah (Principal Investigator,, Assiut University) — Principal investigator
First posted
Sep 23, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Nov 30, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Sep 23, 2022

Study contacts

Mohamed Ashraf
Contact
Mohamed.20134268@med.au.edu.eg
+201050815922
Mohamed Taghian, professor
Contact
Mtaghyan@gmail.com
+201006876892
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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