Clinical trial NCT02452541: TBI-Prognosis Multicenter Prospective Study
Official title: Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Critically ill Patients
Death
Head Injury
TBI-Prognosis
Critical Care Medicine
Withdrawal of Life Sustaining Therapy
Prognosis
Prognostic Evaluation
Outcome Research
Mortality
Decision-making
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
name: Canadian Critical Care Trials Group
First posted: 2015-05-22
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Severe traumatic brain injury (TBI) is the leading cause of death and disability among people under 45 years of age and a major public health problem. Although management of severe TBI patients has gradually improved with the establishment of intensive care units (ICU) and the development of practice guidelines, mortality is still high - ranging from 30 to 50% - with 30% of survivors suffering from severe neurological sequelae such as neurovegetative states. Families and medical teams are frequently called upon to determine reasonable and appropriate goals of care for brain injured patients. They may have to consider high intensity of care, but also the withdrawal of life-sustaining therapies in accordance with patient wishes. Physicians involved in the care of severe traumatic brain injury have expressed serious concerns about hasty decisions made in the absence of appropriate evidence of unfavourable prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a multimodal approach of different prognostic indicators and their evolution over time in the acute phase of care. The results of this study will provide better objective information that will facilitate the shared-decision making-process with families and relatives.


Eligibility criteria: Inclusion Criteria:

* Adults (≥ 18 years) with severe blunt TBI admitted to the ICU
* All patients with a GCS ≤ 8 after initial resuscitation

Exclusion Criteria:

* Anticipated being on mechanical ventilation for \< 48 hour period due to an altered level of consciousness related to the TBI plus another potentially reversible factor (i.e. drugs, substance abuse, excessive sedation, etc.).
* Solid malignancy with a life expectation \<12 months
* Liver cirrhosis Child C
* Chronic heart failure (NYHA class IV)
* End-stage chronic respiratory disease (O2 dependent)
* End-stage renal disease (initiated or expectant chronic dialysis or to be expected)
* Previous neurologic disorder with abnormal findings (such as a mass lesion) on radiological imaging (CT-scan, MRI) or electrophysiological tests (EEG, SSEP) (such as previous uncontrolled epilepsy, significant stroke, previous or acute concomitant spinal cord injury, etc)
* Patients with no fixed address will be excluded because of the difficult follow-up
* Physician refusal

Primary outcomes:
measure: Glasgow Outcome Scale Extended
timeFrame: 12 months
Secondary outcomes:
measure: EuroQuol - EQ-5D-5L
timeFrame: 12 months
measure: Glasgow Outcome Scale Extended
timeFrame: 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Health Sciences Centre
state: Alberta
city: Edmonton
country: Canada
facility: Capital Health - Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Capital Health - University Of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Center
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: ST. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Hôpital Sacré-Coeur de Montréal
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Hôpital de l'Enfant-Jésus
state: Quebec
city: Sherbrooke
country: Canada
facility: CHU Sherbrooke - Hôpital Fleurimont
state: Quebec
Study officials:
affiliation: CHU de Quebec Research Center
name: Alexis Turgeon, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: