Skip to main content
OpenTrials
Completed

NCT Number: NCT02828527

Care Courses for Mild Head Injury Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Head Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Primary outcomes

  1. Assessment of change in Glasgow score

    Time frame: submitted between Day 0 and Day 15 and between Day 15 and Day 30

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2016
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.