PariS-TBI Study : Paris Severe Traumatic Brain Injury Study

NCT01437683 | Completed DMC

• 1 other identifier: 2009-A01122-55
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Craniocerebral Trauma; Trauma Nervous System

Keywords

Craniocerebral Trauma; Quality of life; Long term outcome; Activities of Daily Living; Cognitive Deficiency; Health Care Quality, Access, and Evaluation

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale-Extended

  Between 3 to 5 years post-traumatism

  five years

Secondary Outcomes (3)

• Neurobehavioural Rating Scale-Revised

  Five years

• Dysexecutive Questionnaire

  Five years

• Questionnaire of complaints (patient and care giver)

  Five years

Study Arms (1)

traumatic brain injury patients

a large group of traumatic brain injury patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

traumatic brain injury patients

You may qualify if:

• 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

You may not qualify if:

• Dead before care by emergency

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut de Recherche en Santé Publique, France: collaborator
• CRFTC: collaborator
• Caisse Nationale de Solidarité pour l'Autonomie: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• HAS: collaborator
• DREES: collaborator

Study Sites (1)

CRFTC Centre Ressources Francilien du Traumatisme Crânien

Paris, 75014, France

Location

Related Publications (2)

• Camara-Costa H, Dellatolas G, Jourdan C, Ruet A, Bayen E, Vallat-Azouvi C, Allain P, Chevignard M, Azouvi P. The 20-item dysexecutive questionnaire after severe traumatic brain injury: Distribution of the total score and its significance. Neuropsychol Rehabil. 2025 Jun;35(5):1059-1080. doi: 10.1080/09602011.2024.2387065. Epub 2024 Aug 6.

  PMID: 39106184 DERIVED

• Vallee F, Nougue H, Cartailler J, Kounde PR, Mebazaa A, Gayat E, Azouvi P, Mateo J. The ICEBERG: A score and visual representation to track the severity of traumatic brain injury: Design principles and preliminary results. J Trauma Acute Care Surg. 2022 Aug 1;93(2):229-237. doi: 10.1097/TA.0000000000003515. Epub 2022 Jan 6.

  PMID: 35001023 DERIVED

MeSH Terms

Conditions

Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries

Study Officials

• Philippe AZOUVI, PU-PH

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: September 21, 2011
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2012
• Last Updated: October 15, 2012

Record last verified: 2010-11

Locations

FR (1)