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临床试验/NCT02828527
NCT02828527已完成不适用

Care Courses for Mild Head Injury Patients

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Assessment of change in Glasgow score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Assessment of change in Glasgow score

时间窗: submitted between Day 0 and Day 15 and between Day 15 and Day 30

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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