PariS-TBI Study : Paris Severe Traumatic Brain Injury Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Demographic and pre-traumatism clinical data will be available from the initial study, as well as data on type and severity of traumatism, and on evolution during acute care. Early outcome data include cognitive disability (Dysexecutive Questionnaire), global participation (Glasgow Outcome Scale-Extended), and return to work.

Data assessed through the present study will include an evaluation of deficiencies: presence and importance of motor sequelae, cerebellar dysfunction, visual or auditive deficiencies, epilepsy, chronic pain. Cognitive deficiencies will be assessed through the Neurobehavioural Rating Scale-Revised, the Dysexecutive Questionnaire, and a questionnaire of complaints from the patient and from his informal care giver.

Activities will be evaluated by the Barthel index. Capacity of motor vehicle driving will be assessed. Participations will be measured globally with the Glasgow Outcome Scale-Extended, and specifically by a SOCIO-professional integration questionnaire and the BICRO-39 scale.

Quality of life will be assessed through the EuroQoL questionnaire, and a global evaluation of the patient's quality of life on a 0-10 numeric scale from the patient and from his care giver. The Hospital Anxiety and Depression Score will be measured.

Data on patients' pathway and intensity of clinical care will be collected: the clinical pathway from acute care to home or health care facility discharge, a quantification of clinical follow up and rehabilitation. The patient's environment (place of living, presence of informal carers) will be assessed, as well as modality of return to work.

The questionnaire will include data on financial compensations and intensity of formal home care.

Data on the quality of life of the informal care giver and an evaluation of the burden of care will be collected, using the ZARIT questionnaire.

The exploitation of this large data base will enable an up-to-date description of the long term outcomes of severe TBI patients in the Parisian area. It will be used to clarify the role of several factors on long term activities, participations and quality of life for severe TBI patients, the hypothesis being that factors directly related to the severity of the traumatism play a smaller role in long term outcome than SOCIO-environmental characteristics such as professional category, intensity of rehabilitation care, presence of informal care.

Statistical analysis will be conducted with the R® statistical software. Association between various predictive factors and outcome (GOSE, BICRO-39, EuroQoL) will be assessed through UNIVARIOUS tests, followed by multivarious regression models, using a backward selection strategy to select relevant variables.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injury Craniocerebral Trauma Trauma Nervous System

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

traumatic brain injury patients

a large group of traumatic brain injury patients

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe AZOUVI, PU-PH

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CRFTC Centre Ressources Francilien du Traumatisme Crânien

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 39106184 (View on PubMed)

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.

Reference Type DERIVED

PMID: 35001023 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-A01122-55

Identifier Type: -

Identifier Source: org_study_id