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PariS-TBI Study : Paris Severe Traumatic Brain Injury Study

This study has been completed.
Sponsor:
Collaborators:
IRESP
CRFTC
CNSA: CAISSE NATIONALE DE SOLIDARITE POUR L'AUTONOMIE
Institut National de la Santé Et de la Recherche Médicale, France
HAS
DREES
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01437683
First received: August 5, 2011
Last updated: October 12, 2012
Last verified: November 2010
History of Changes
  Purpose

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.


Condition
Brain Injury
Craniocerebral Trauma
Trauma Nervous System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Four Year Outcome After Severe Traumatic Brain Injury in the Parisian Area

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Glasgow Outcome Scale-Extended [ Time Frame: five years ] [ Designated as safety issue: No ]
    Between 3 to 5 years post-traumatism


Secondary Outcome Measures:
  • Neurobehavioural Rating Scale-Revised [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • Dysexecutive Questionnaire [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • Questionnaire of complaints (patient and care giver) [ Time Frame: Five years ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: February 2010
Study Completion Date: June 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
traumatic brain injury patients
a large group of traumatic brain injury patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

traumatic brain injury patients

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Dead before care by emergency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437683

Locations
France
CRFTC Centre Ressources Francilien du Traumatisme Crânien
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
IRESP
CRFTC
CNSA: CAISSE NATIONALE DE SOLIDARITE POUR L'AUTONOMIE
Institut National de la Santé Et de la Recherche Médicale, France
HAS
DREES
Investigators
Principal Investigator: Philippe AZOUVI, PU-PH APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01437683     History of Changes
Other Study ID Numbers: 2009-A01122-55
Study First Received: August 5, 2011
Last Updated: October 12, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Craniocerebral Trauma
Quality of life
Long term outcome
 Activities of Daily Living
Cognitive Deficiency
Health Care Quality, Access, and Evaluation

Additional relevant MeSH terms:
Craniocerebral Trauma
Wounds and Injuries
Brain Injuries
Trauma, Nervous System
 Nervous System Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013