Extradural HematomaNCT05552703
Traumatic Extradural Hematoma in Paediatric Age Group
An observational study of Extradural Hematoma, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Extradural Hematoma
- What is being tested?
- surgical evacuation of extradural hematoma
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.
Who may be able to join
- All pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.
Who cannot join
- Patients aged more than 18 years old.
- patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Extradural Hematoma
- Being tested
- surgical evacuation of extradural hematoma
- Keywords
- paediatrics
- Medical subject headings
- Hematoma, Epidural, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical evacuation of extradural hematomaProcedure or surgery
evacuation of extradural hematoma by craniotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
glascow outcome scale
The Glasgow Outcome Scale (GOS) categorizes the outcomes of patients after traumatic brain injury, as follows
- Persistent vegetative state: Minimal responsiveness
- Severe disability: Conscious but disabled; dependent on others for daily support
- Moderate disability: Disabled but independent; can work in sheltered setting
- Good recovery: Resumption of normal life despite minor deficits
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (2)
mortality
patients who died after surgery
Measured: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
morbidity
patients with disability after surgery
Measured: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extradural HematomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Salah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552703
- Sponsor's protocol ID
- EDH in paediatric
- Status last verified
- Sep 2022
- First submitted
- 17 Nov 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Extradural Hematoma in Paediatric Age Group
- ClinicalTrials.gov ID
- NCT05552703
- Acronym / sponsor ID
- EDH in paediatric
- Conditions
- Extradural Hematoma
- Keywords
- paediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Sep 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.
Key inclusion criteria (1 listed)
- All pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.
Key exclusion criteria (2 listed)
- Patients aged more than 18 years old.
- patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.
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 |
|---|---|---|
| surgical evacuation of extradural hematomaevacuation of extradural hematoma by craniotomy | Procedure or surgery | – |
Primary outcome
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 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
2 secondary outcomes
mortality
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Extradural Hematoma, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ashraf (+201050815922, Mohamed.20134268@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glascow outcome scale (time frame: immediately after the intervention/procedure/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 23 Sep 2022.