Clinical trial NCT02828527: Care Courses for Mild Head Injury Patients
Official title: Care Courses for Mild Head Injury Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Head Injury
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to emergency Unit of Hopital Paris Saint Jospeh

Brief summary: Background / Rationale at. The mild head injury.

In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of mild head trauma. This is a pattern of frequent use of the health system. The reason for consultation, benign appearance, present a significant risk of complication. In 15 to 25% of the evolution of head injury is unfavorable. Disorders of attention, memory disorders, psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome, post-concussion syndrome.

The post-concussion syndrome:

It affects approximately 20,000 people per year in France. This is a common disease and most undervalued in the general population. diagnostic criteria post-concussional disorder according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3 months after head injury. This syndrome is responsible for suffering, personal and professional sound and quality of life of patients. It is particularly debilitating in everyday life, and can have disastrous consequences on their family, social, cultural and professional. It gives rise to many financial implications with compensation requirements and expertise consultations.

Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has been shown that screening and early treatment of post-concussion syndrome from the slight head injury prevents chronicity of symptoms.

Detailed description: Methodology :

Design: Cohort study single-center prospective observational. Recruitment period: 15/11/2014 to 15/12/2014 approximately (50 records necessary).

Then follow a month is required. Either theoretical study end: 01/15/2015.

Acquisition of data:

Pre inclusion of patients in the study by sorting CAE emergency department on the following host pattern: traumatic brain injury with loss of consciousness, traumatic brain injury without loss of consciousness, with loss of consciousness discomfort, discomfort without a loss of consciousness peripheral vascular accident PVA.

Collection address, telephone number and an e-mail address of the patient (after delivery of a newsletter).

call the patient and questionnaire submitted between 0 and J15 and J15 and J30 between.

Eligibility criteria: Before Inclusion Criteria:

* Traumatic brain injury
* Head injury with loss of consciousness
* Cranio facial trauma
* Peripheral vascular accident
* Discomfort
* Discomfort with loss of consciousness

Before Inclusion Criteria:

* Head trauma notion AND at least one of the following criteria:
* Loss of consciousness \<30 minutes
* Glasgow between 13 and 15
* Post Traumatic Amnesia \<24H
* Altered mental status at the time of the accident (dizziness, confusion, disorientation)
* Transient focal neurological deficit

Exclusion Criteria:

* \<18
* Major Trust
* Context of acute alcohol (\> 3 glasses) or toxic taking (drugs)
* Not understanding or communication
* Patient Refusal

Primary outcomes:
measure: Assessment of change in Glasgow score
timeFrame: submitted between Day 0 and Day 15 and between Day 15 and Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: AÏM Jean luc, MD
role: PRINCIPAL_INVESTIGATOR
References: