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The PIT-TBI prospective multicenter pilot cohort study

Funding: Fonds de Recherche du Québec – Santé; Canadian Institutes of Health Research
Status: Recruitment completed

PI: François Lauzier

Co-Is: Alexis F. Turgeon, Lynne Moore, Patrick Archambault, Francis Bernard, Amélie Boutin, Deborah Cook, Claudia Gagnon, Donald Griesdale, Margaret Herridge, Geneviève Houde, François Lamontagne, Lauralyn McIntyre, Karene Menon, Giusseppe Pagliarello, Pascal Perron, François Rousseasu, Damon Scales

Traumatic brain injury (TBI) is a major cause of mortality and morbidity. Many survivors suffer from concentration deficit, fatigue, depression and low resistance to effort. These symptoms affect their quality of life, their functional level and have a significant impact on the utilization of primary health care resources. Several of these symptoms could be attributable to hormonal deficits. In fact, pituitary disorders are an often neglected side effect of TBI. Nonetheless, studies published to date have not adequately evaluated the clinical impact of pituitary disorders nor their risk factors in the context of TBI.

The main objectives of this study are to evaluate the feasibility of conducting a large multicenter prospective observational cohort study. To this end, we will evaluate protocol adherence and estimate the recruitment rate at each participating center.

This study, conducted in 6 trauma centers across Canada, is a critical step in an innovative research program on pituitary disorders that will have a significant impact on health care in Canada. If our results demonstrate that pituitary disorders affect the neurological prognostic, functional status, quality of life or depressive symptoms of patients, the implementation of a systematic screening strategy to detect these disorders in patients suffering from TBI will be justified. These results would also justify conducting a randomized clinical trial to evaluate the relevance of initiating hormonal replacement therapy in this group of patients. On the other hand, if we show that pituitary disorders and prognostics are not linked, our results will prevent unnecessary, costly screening and prevent potentially harmful hormonal replacement therapy in this vulnerable population.

CHU de Québec – Hôpital de l’Enfant-Jésus (Quebec City, Quebec)
Hôpital de Sacré-Coeur de Montréal (Montreal, Quebec)
Centre Hospitalier Universitaire de Sherbrooke (Sherbrooke, Quebec)
The Ottawa Hospital (Ottawa, Ontario)
Sunnybrook Health Sciences Centre (Toronto, Ontario)
Vancouver General Hospital (Vancouver, British Columbia)

For more information go to clinicaltrials.gov