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PariS-TBI Study : Paris Severe Traumatic Brain Injury Study (PariS-TBI)

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ClinicalTrials.gov Identifier: NCT01437683
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : October 15, 2012
Sponsor:
Collaborators:
IRESP
CRFTC
Caisse Nationale de Solidarité 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

Brief Summary:

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 or disease
Brain Injury Craniocerebral Trauma Trauma Nervous System

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Four Year Outcome After Severe Traumatic Brain Injury in the Parisian Area
Study Start Date : February 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
traumatic brain injury patients
a large group of traumatic brain injury patients



Primary Outcome Measures :
  1. Glasgow Outcome Scale-Extended [ Time Frame: five years ]
    Between 3 to 5 years post-traumatism


Secondary Outcome Measures :
  1. Neurobehavioural Rating Scale-Revised [ Time Frame: Five years ]
  2. Dysexecutive Questionnaire [ Time Frame: Five years ]
  3. Questionnaire of complaints (patient and care giver) [ Time Frame: Five years ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437683


Locations
France
CRFTC Centre Ressources Francilien du Traumatisme Crânien
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
IRESP
CRFTC
Caisse Nationale de Solidarité pour l'Autonomie
Institut National de la Santé Et de la Recherche Médicale, France
HAS
DREES
Investigators
Principal Investigator: Philippe AZOUVI, PU-PH APHP

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01437683     History of Changes
Other Study ID Numbers: 2009-A01122-55
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: November 2010

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:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System