Care Courses for Mild Head Injury Patients

March 12, 2018 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to emergency Unit of Hopital Paris Saint Jospeh

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of change in Glasgow score
Time Frame: submitted between Day 0 and Day 15 and between Day 15 and Day 30
submitted between Day 0 and Day 15 and between Day 15 and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: AÏM Jean luc, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parcours TC léger

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.

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