Projects

TBI-Prognosis prospective study

PROBLEMATIC

Severe traumatic brain injury (TBI) is a major public health issue, and most frequent cause of death and disability among healthy young adults. Families and medical teams are frequently called upon to determine appropriate intensities of care for victims of severe TBI, and frequently consider withdrawal of life-sustaining therapies. However, our previous work showed a significant variation across Canada in mortality following the withdrawal of life-sustaining therapies in this setting. Evidence-based recommendations for the early assessment of prognosis are scarce and based on prognostic tools and models with minimal clinical utility. Early determination of prognosis in severe TBI is of great concern not only for health workers and families, but also for the society as a whole.

STUDY HYPOTESIS

The combination of different prognostic indicators and of their evolution over time in the acute phase of care will allow the development of a reliable prognostic model.

OBJECTIVES

To develop a valid, integrated, reliable and clinically useful prognostic model (decision aid) to evaluate the long-term prognosis (functional and quality of life) of critically ill adults with severe TBI using a combination of different known prognostic indicators.

STUDY PARTICIPANTS

Critically ill adult patients with severe blunt TBI admitted to 17 Canadian ICUs. Patients with a GCS ≤ 8 after initial resuscitation.

METHODS

We will perform a multicenter prospective cohort study in which no therapeutic intervention will be tested. A schedule of tests will be conducted within the first week of admission. Known and potential prognostic indicators will be collected from day 0 to 7. These predictors are related to the event, to demographics, to clinical data (secondary neurological injuries and neurological signs), to type of lesions on radiological imaging, to electrophysiological findings and to serum biological markers.

PROGNOSTIC INDICATORS

Baseline information will be captured on admission. Clinical data will be measured every day. Other prognostic tests will be measured on admission and at specific time- periods within the first week (CT-scan and three biomarker [S100B, NSE, UCH-L1] at day 0 and 3, 7; MRI, EEG and SSEPs on day 7). A time-window of 48 hours will be allowed for feasibility reasons. Standard therapeutic strategies will be recommended for all patients as per the guidelines from the Brain Trauma Foundation.

OUTCOMES

The primary outcome will be the extended Glasgow Outcome Scale (GOSe) at 12 months. Secondary outcomes will be EQ-5D at 12 months and GOSe at 6 months.

POTENTIAL IMPACT OF THE WORK

The proposed definitive cohort study will provide the best epidemiologic description available of patients with moderate and severe TBI, along with exhaustive outcome measures at different time period after the injury. The identification of evidence-based prognostic tools could help define realistic expectations for physicians and relatives. A better understanding of prognosis would also assist with hypothesis generation about biological mechanisms that, in turn, could aid with research into therapies and risk stratification of patients for quality assurance programs / research.

FUNDING

This study is funded by the Canadian Institutes of Health Research.

CO-INVESTIGATORS AND COLLABORATORS

• François Lauzier, Dr. Jérôme Paquet, Dr. Jean-Luc Gariepy, Linda Nadeau, Dr. Lynne Moore, Dr. Véronique Moulin, Dr. Martin Savard
• Robert Green, Dr. Simon Walling, Dr. Sean Christie
• Ryan Zarychanski, Dr. Stephen Howalski, Dr. Neil Berrington
• Jim Kutsogiannis, Dr. Max Findlay
• Maureen Meade, Dr. Draga Jichici, Dr. Kesava KV Reddy
• Damon Scales, Dr Nicolas Phan, Vivekanandan Thavalasuthan, Jo Mantia, Dr. Esther Bui, Dr G. Bryan Young, Ekaterina Potapova
• Donald Griesdale, Dr. Gary J Redekop, Dr.Manouchehr Javidan
• Kosar Khwaja,
• Andrea Rigamonti, Dr. Karen Burns, Dr. Loch Macdonald, Dr. Michael Cusimano, Dr. Jacob Schneiderman
• François Lamontagne, Dr. David Mathieu, Dr. Jean Chénard, Dr. Albert Lamontagne, Dr. Charles Deacon
• Shane English, Dr. Giuseppe Pagliarello, Dr. Lauralyn McIntyre, Dr. Dean Fergusson, Dr. John Sinclair, Dr. David Houlden, Dr. Rafael Glikstein, Dr. Leo Renaud
• Steven Reynolds, Dr Andrew Sak Yu Lee,
• Claudia Martin, Dr. Eyad Althenayan, Dr Ian Ball, Dr Sandrine de Ribaupierre, Dr. Bryan Young
• Andreas Kramer, Dr. Clare Gallagher, Dr. Phillippe Couillard
• David Zygun, Dr. Sean Bagshaw, Dr. Max Findlay, Dr. S. Nizam Ahmed
• Gordon Wood

CENTERS

• CHU de Québec – Université Laval (Hôpital de l’Enfant-Jésus) (Québec city, Québec)
• Queen Elizabeth II Health Sciences Center (Halifax, Nova Scotia)
• Winnipeg Health Sciences Center (Winnipeg, Manitoba)
• Royal Alexandra Hospital (Edmonton, Alberta)
• Hamilton Health Sciences Center (Hamilton, Ontario)
• Sunnybrook Health Sciences Center (Toronto, Ontario)
• Vancouver General Hospital (Vancouver, British Columbia)
• Montreal General Hospital (Montréal, Québec)
• St-Michael’s Hospital (Toronto, Ontario)
• Centre Hospitalier Universitaire de Sherbrooke (Sherbrooke, Québec)
• The Ottawa Hospital (Ottawa, Ontario)
• Royal Colombian Hospital (New Westminster, British Columbia)
• London Health Sciences Center (London, Ontario)
• Foothills Health Sciences Center (Calgary, Alberta)
• University of Alberta Hospital (Edmonton, Alberta)
• Royal Jubilee Hospital (Victoria, British Columbia)
• Hôpital du Sacré-Coeur de Montréal (Montréal, Québec)