Traumatic Brain Injury Clinical Trial
Official title:
Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study
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.
Status | Active, not recruiting |
Enrollment | 315 |
Est. completion date | September 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Health Sciences Centre | Calgary | Alberta |
Canada | Capital Health - Royal Alexandra Hospital | Edmonton | Alberta |
Canada | Capital Health - University Of Alberta Hospital | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Hamilton Health Sciences Center | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | Hôpital Sacré-Coeur de Montréal | Montréal | Quebec |
Canada | Royal Columbian Hospital | New Westminster | British Columbia |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | CHU de Québec - Hôpital de l'Enfant-Jésus | Québec | Quebec |
Canada | CHU Sherbrooke - Hôpital Fleurimont | Sherbrooke | Quebec |
Canada | ST. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | Royal Jubilee Hospital | Victoria | British Columbia |
Canada | Winnipeg Health Sciences Center | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Québec, CHU de Québec | Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glasgow Outcome Scale Extended | 12 months | No | |
Secondary | EuroQuol - EQ-5D-5L | 12 months | No | |
Secondary | Glasgow Outcome Scale Extended | 6 months | No |
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