- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02357186
Broad Validation Study of a Management Algorithm Mild Head Injury in Children (EVEACE)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49933
- Angers University Hospital
-
Brest, France, 29609
- Brest University Hospital
-
La Roche sur Yon, France, 85925
- Centre Hospiatlier Départemental de Vendée
-
Nantes, France, 44093
- Nantes University Hospital
-
Poitiers, France, 86021
- Poitiers university hospital
-
Rennes, France, 35203
- Rennes University Hospital
-
Saint-Nazaire, France, 44606
- Saint-Nazaire Hospital
-
Toulouse, France, 31000
- Toulouse University Hospital
-
Tours, France, 37044
- Tours University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fleur Lorton, Dr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC15_0038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head Injury
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)UnknownWounds and Injuries | Closed Head InjuryCanada
-
U.S. Army Medical Research and Development CommandNational Institutes of Health Clinical Center (CC); National Institute on Alcohol... and other collaboratorsCompletedTraumatic Brain Injury | Penetrating Head Injury | Closed Head TraumaUnited States
-
Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States
-
University of PittsburghCompletedHead Injury, MinorUnited States
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States, Uganda
-
University Hospital, CaenUnknown
-
Centre Hospitalier Universitaire DijonCompleted
-
Makerere UniversityCompletedSevere Head InjuryUganda
-
Centre Hospitalier Universitaire de NīmesNot yet recruitingPenetrating Head Injury | Closed Head InjuryFrance