PariS -TBI Study: Paris Severe Traumatic Brain Injury Study - 8 Years

NCT02050633 | Unknown DMC

• 1 other identifier: 2013-A00881-44
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the protocol is to pursue the long-term follow-up of a large cohort of severe traumatic brain injury patients. This outcome is to be described in terms of activity, participation, quality of life, socio-professional outcome, economical consequences and impact on caregivers, and in relation to health care provision. Secondary objectives are to measure the impact on outcome of several predictive factors; to evaluate evolution of patients since the last (four-year) evaluation.

Conditions

Brain Injury; Craniocerebral Trauma; Trauma, Nervous System

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale-Extended

  This scale is assessed by a structured interview about the difficulties the patient in simple or elaborate acts of daily life

  Eight years post-injury (one unique all-including evaluation)

Secondary Outcomes (8)

• Neuropsychological testing: memory (California Verbal Learning Test), executive functioning (6-Elements Test, Dysexecutive Questionnaire by patient and caregiver), speed index (Trail Making Test, WAIS-IV Processing Speed Index).

  Eight years post-injury (one unique all-including evaluation)

• TBI-related complaints, by patient and caregiver

  Eight years post-injury (one unique all-including evaluation)

• Capacity of motor vehicle driving, independence in daily living activities

  Eight years post-injury (one unique all-including evaluation)

• Socio-professional integration

  Eight years post-injury (one unique all-including evaluation)

• Hospital Anxiety and Depression

  Eight years post-injury (one unique all-including evaluation)

Study Arms (1)

Severe cranial trauma

This is a cohort of adult patients who have suffered a severe TBI between 1 July 2005 and 1 May 2007.

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

Patients had severe TC in the Parisian area between 2005 and 2008 and were evaluated 4 years.

You may qualify if:

• Adults
• 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)

You may not qualify if:

• Refusal to participate
• Impossibility to contact the person
• Current living place outside the Parisian area
• Impossibility to answer the questionnaire, in the absence of a proxy to assist

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CRFTC

Paris, 75014, France

Location

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

• Claire CJ Jourdain, MD

  Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

FR (1)