NCT05552703

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

November 17, 2021

Last Update Submit

September 21, 2022

Conditions

Extradural Hematoma

Keywords

paediatrics

Outcome Measures

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

    immediately after the intervention/procedure/surgery

Secondary Outcomes (2)

  • mortality

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

  • morbidity

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

Interventions

surgical evacuation of extradural hematomaPROCEDURE

evacuation of extradural hematoma by craniotomy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients aged more than 18 years old.
  • patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hematoma, Epidural, Spinal

Condition Hierarchy (Ancestors)

HematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Ashraf

CONTACT

+201050815922Mohamed.20134268@med.au.edu.eg

Mohamed Taghian, professor

CONTACT

+201006876892Mtaghyan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

November 17, 2021

First Posted

September 23, 2022

Study Start

October 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share