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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
70
Pituitary function evaluation performed at hospital discharge, 6 and 12 months * Thyroid-stimulating hormone, free T4 and T3 * Follicle stimulating hormone, luteinizing hormone, estradiol, bioavailable testosterone * Adrenocorticotropic hormone stimulation test * Glucagon test (growth hormone deficit) Risk factors evaluation of pituitary dysfunction * Demographic data * Daily data (clinical exam, secondary brain injuries) * Hormone levels on day 1, 3 and 7 * Biomarkers on day 1, 3 and 7 * Brain CT-Scan on day 1 * Pituitary MRI on day 7 Outcome measures at 6 and 12 months * Neurological recovery (GOSe) * Independent functioning (FIM) * Quality of life (EQ-5D-5L) * Life satisfaction (LISAT-11) * Depression (PHQ-9)
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
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
Adherence to the Protocol
Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section
Time frame: 12 months
Enrollment Rate
Number of patients recruited per month per site
Time frame: 12 months
Neurological Recovery
Glasgow Outcome Scale Extended (GOSe)
Time frame: 12 months
Quality of life
EuroQuol - EQ-5D-5L questionnaire
Time frame: 12 months
Independent functioning
Functional Independence Measure (FIM) questionnaire
Time frame: 12 months
Depression
Patient Health Questionnaire (PHQ-9)
Time frame: 12 months
Life satisfaction
Life Satisfaction Questionnaire (LISAT)
Time frame: 12 months
Secondary hypothyroidism
Time frame: 12 months
Secondary hypogonadism
Time frame: 12 months
Secondary adrenal insufficiency
Time frame: 12 months
Growth hormone deficit
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.