Head InjuryEVEACENCT02357186
Broad Validation Study of a Management Algorithm Mild Head Injury in Children
An observational study of Head Injury, run by Nantes University Hospital at 9 sites in France.
Trial summary
Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Head Injury
- How many people
- 7,871 participants
- Where
- 9 sitesFrance
- Study dates
- 16 Nov 2015to Sep 2018
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Will be included in the study all children under 16 years of age admitted to the emergency room with mild head trauma with a Glasgow score greater than or equal to 14, occurred in the previous 24 hours. The mild head injury is usually defined by a GCS ≥ 13, but the study of the Pediatric Emergency Care Applied Research Network was interested in the population of children with TBI Glasgow score was greater than or equal to 14. Indeed the care of children with head trauma with a Glasgow score below 14 is not controversial. The risk of traumatic brain injury is at least 20%, achieving a brain scan is routinely recommended for these children. The investigators will resume the same characteristics for the study population as the study of the Pediatric Emergency Care Applied Research Network.
Who may be able to join
- Children under 16 years admitted to an emergency room for mild head injury (Glasgow Coma Scale score ≥14) in the previous 24 hours
- Children who have agreed to participate in the study (if age> 8 years)
- Patient Parents have accepted the participation of their child in the study
Who cannot join
- Children with bleeding disorders
- Ventricular shunt Presence
- Benin mechanism of trauma (fall of the height of the child or impact against an object while walking / running with no sign that the scalp dermabrasion)
- Penetrating trauma
- Known brain tumor
- Previously known neurological disorders
- Evaluation scanographic in another hospital before emergency review
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Angers University Hospital
Angers, 49933
Brest University Hospital
Brest, 29609
Centre Hospiatlier Départemental de Vendée
La Roche-sur-Yon, 85925
Nantes University Hospital
Nantes, 44093
Poitiers University Hospital
Poitiers, 86021
Rennes University Hospital
Rennes, 35203
Saint-Nazaire Hospital
Saint-Nazaire, 44606
Toulouse University Hospital
Toulouse, 31000
Tours University Hospital
Tours, 37044
About this study
Official title: Multicenter Prospective Broad Validation of a Management Algorithm Mild Head Injury in Children
Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions.
Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established.
The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.
- Conditions
- Head Injury
- Keywords
- Mild head injury - clinical decision rule - Child
- Medical subject headings
- Craniocerebral Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically severe intracranial injury and classified at risk (top and middle) according to clinical decision rule in all patients with severe intracranial lesions.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start16 Nov 2015
- Primary completionAug 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- 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
- 7,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fleur Lorton, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357186
- Sponsor's protocol ID
- RC15_0038
- Acronym
- EVEACE
- Status last verified
- Dec 2018
- First submitted
- 21 Jan 2015
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Broad Validation of a Management Algorithm Mild Head Injury in Children
- ClinicalTrials.gov ID
- NCT02357186
- Acronym / sponsor ID
- EVEACE / RC15_0038
- Conditions
- Head Injury
- Keywords
- Mild head injury - clinical decision rule - Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,871 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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.
Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions.
Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established.
The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Will be included in the study all children under 16 years of age admitted to the emergency room with mild head trauma with a Glasgow score greater than or equal to 14, occurred in the previous 24 hours. The mild head injury is usually defined by a GCS ≥ 13, but the study of the Pediatric Emergency Care Applied Research Network was interested in the population of children with TBI Glasgow score was greater than or equal to 14. Indeed the care of children with head trauma with a Glasgow score below 14 is not controversial. The risk of traumatic brain injury is at least 20%, achieving a brain scan is routinely recommended for these children. The investigators will resume the same characteristics for the study population as the study of the Pediatric Emergency Care Applied Research Network.
Key inclusion criteria (3 listed)
- Children under 16 years admitted to an emergency room for mild head injury (Glasgow Coma Scale score ≥14) in the previous 24 hours
- Children who have agreed to participate in the study (if age> 8 years)
- Patient Parents have accepted the participation of their child in the study
Key exclusion criteria (7 listed)
- Children with bleeding disorders
- Ventricular shunt Presence
- Benin mechanism of trauma (fall of the height of the child or impact against an object while walking / running with no sign that the scalp dermabrasion)
- Penetrating trauma
- Known brain tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with clinically severe intracranial injury and classified at risk (top and middle) according to clinical decision rule in all patients with severe intracranial lesions.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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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.
Fleur Lorton, Dr principal investigator
Nantes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury, run by Nantes University Hospital at 9 sites in France.
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 7 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: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with clinically severe intracranial injury and classified at risk (top and middle) according to clinical decision rule in all patients with severe intracranial lesions. (time frame: one month). 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 12 Dec 2018.