NCT02480985

The PIT-TBI Pilot Study

Clinical Outcomes and Predictors of PITuitary Disorders in Patients With Moderate and Severe Traumatic Brain Injury: the PIT-TBI Prospective Multicenter Pilot Cohort Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pituitary Disorders
• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Pituitary function evaluation	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)

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-06-25
• Last updated: 2017-03-27

Locations

5 sites across 1 country: Canada