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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Canadian Critical Care Trials Group | OTHER |
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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Damage to the pituitary gland is a frequently overlooked but potentially important complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur immediately or several months after TBI, may delay recovery and may have a significant negative impact on quality of life. TBI is the leading cause of disability and major permanent functional impairment among adults under 45 years of age. Hormonal deficits may contribute to common symptoms experienced by TBI survivors such as fatigue, poor concentration, depression and low exercise capacity. However, the association between hormonal deficits and disability remains uncertain. The primary objective of this pilot study is to assess the feasibility of a larger study that will evaluate the impact of pituitary disorders on neurological disability and functional recovery. The results of this study will provide key findings in the impact of pituitary disorders following TBI, which is a mandatory step prior testing the effect of hormonal replacement therapy in this population in costly clinical trials. If no relationship between pituitary disorders and disability is observed, the investigators' findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pituitary function evaluation | Other | Exams performed according to a determined schedule following admission in the intensive care unit in order to determine the risk factors and the outcome associated with pituitary disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pituitary function evaluation | Other | Pituitary function evaluation performed at hospital discharge, 6 and 12 months
Risk factors evaluation of pituitary dysfunction
Outcome measures at 6 and 12 months
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the Protocol | Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section | 12 months |
| Enrollment Rate | Number of patients recruited per month per site | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Recovery | Glasgow Outcome Scale Extended (GOSe) | 12 months |
| Quality of life | EuroQuol - EQ-5D-5L questionnaire | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Lauzier, MD MSc FRCPC | CHU de Quebec Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | Canada | |||
| Sunnybrook Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24247474 | Background | Lauzier F, Turgeon AF, Boutin A, Shemilt M, Cote I, Lachance O, Archambault PM, Lamontagne F, Moore L, Bernard F, Gagnon C, Cook D. Clinical outcomes, predictors, and prevalence of anterior pituitary disorders following traumatic brain injury: a systematic review. Crit Care Med. 2014 Mar;42(3):712-21. doi: 10.1097/CCM.0000000000000046. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Independent functioning | Functional Independence Measure (FIM) questionnaire | 12 months |
| Depression | Patient Health Questionnaire (PHQ-9) | 12 months |
| Life satisfaction | Life Satisfaction Questionnaire (LISAT) | 12 months |
| Secondary hypothyroidism | 12 months |
| Secondary hypogonadism | 12 months |
| Secondary adrenal insufficiency | 12 months |
| Growth hormone deficit | 12 months |
| Toronto |
| Ontario |
| Canada |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | Canada |
| CHU de Québec - Hôpital de l'Enfant-Jésus | Québec | Quebec | Canada |
| CHU de Sherbrooke - Hôpital Fleurimont | Sherbrooke | Quebec | Canada |
| D004700 | Endocrine System Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |