Broad Validation Study of a Management Algorithm Mild Head Injury in Children

Head Injury Clinical Trial

— EVEACE  

Official title:

Multicenter Prospective Broad Validation of a Management Algorithm Mild Head Injury in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357186
• Other study ID #: RC15_0038
• Status: Completed
• Start date: November 16, 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7871
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury
• Wounds and Injuries

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	Centre Hospiatlier Départemental de Vendée	La Roche sur Yon
France	Nantes University Hospital	Nantes
France	Poitiers University Hospital	Poitiers
France	Rennes University Hospital	Rennes
France	Saint-Nazaire Hospital	Saint-Nazaire
France	Toulouse University Hospital	Toulouse
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one month