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临床试验/NCT01437683
NCT01437683已完成不适用

Four Year Outcome After Severe Traumatic Brain Injury in the Parisian Area

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
252
试验地点
1
主要终点
Glasgow Outcome Scale-Extended

研究概览

简要总结

The primary objective of the protocol is to study the long-term outcome of a large group of traumatic brain injury patients.

This outcome is to be described in terms of activity, participation, quality of life, SOCIO-professional outcome and impact on caregivers, and in relation to health care provision.

The secondary outcome is to measure the impact on functional outcome of several predictive factors, and their relative importance on outcome. Our principal hypothesis is that SOCIO-professional and health provision factors play a major role on long-term outcome, further even than initial severity of brain injury.

详细描述

This work represents a part of a larger collaborative prospective study called PariS-TBI (Severe Traumatic Brain Injury in the Parisian area) financed by the French National Authority for Health. The PariS-TBI study was undertaken in 2005, to provide epidemiological data. Patients aged 15 or more were included if they had sustained a severe TBI in the Parisian area, defined by an initial Coma Glasgow Score (GCS) of 8 or less. During a 20-months period, all consecutive patients who met inclusion criteria were recruited by mobile emergency services. Data from patients' demographics, injury characteristics, acute and post acute phase were collected prospectively. Patients were evaluated through a phone interview at one year post traumatism.

A total of 504 patients were included, of which 257 were alive at the end of acute care.

Investigations of the present work will be undertaken between four and six years after brain injury for survivors. Patients of the initial cohort will be contacted twice through phone call or post. Information about this follow up study will be given orally and through written form. Informed consent of patient or legal advisor will be obtained before setting an appointment for the evaluation.

Evaluation will take place either in the patient's place of living, or in a clinical setting in the hospitals Broussais, Paris, France or Raymond POINCARE, GARCHES, France, according to the patient's choice.

Two trained neuropsychologists will lead the evaluations, during an interview with the patient and the informal care giver, defined as the person (family member or friend), most responsible for day-to-day decision making and care for the patient. If a patient refuses the interview, a short questionnaire will be proposed to him by the neuropsychologist by phone.

研究设计

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

入排标准

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

入选标准

  • Adults and children over 15 years old.
  • Severe TBI with a Glasgow Coma Scale (GCS) score of 8 or less before admission to the hospital.
  • Accident within the Regional Parisian area (Paris and 7 surrounding districts).
  • Alive at emergency arrival

排除标准

  • Dead before care by emergency

结局指标

主要结局

Glasgow Outcome Scale-Extended

时间窗: five years

Between 3 to 5 years post-traumatism

次要结局

  • Neurobehavioural Rating Scale-Revised(Five years)
  • Dysexecutive Questionnaire(Five years)
  • Questionnaire of complaints (patient and care giver)(Five years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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