Care Courses for Mild Head Injury Patients

Mild Head Injury Clinical Trial

Official title:

Care Courses for Mild Head Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828527
• Other study ID #: Parcours TC léger
• Status: Completed
• Phase: N/A
• First received: July 7, 2016
• Last updated: March 12, 2018
• Start date: September 12, 2014
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2018
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Mild Head Injury
• Wounds and Injuries

Intervention

Other:
• Observational

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change in Glasgow score		submitted between Day 0 and Day 15 and between Day 15 and Day 30