The PIT-TBI Pilot Study

Not Applicable

• Conditions: Pituitary Disorders; Traumatic Brain Injury
• Interventions: Other: Pituitary function evaluation

• Registration Number: NCT02480985
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-25
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult (≥ 18 years old)
• Severe or moderate blunt TBI admitted to the ICU with a Glasgow Coma Scale ≤ 12 following initial resuscitation

Exclusion Criteria

• Previously diagnosed or suspected pituitary disorder or disease
• Pregnant or lactating woman
• Penetrating TBI
• Solid malignancy with life expectation <12 months
• Liver Cirrhosis Child C
• Chronic Heart Failure (New York Heart Association class IV)
• End-stage chronic respiratory disease (O2 dependent)
• End-stage renal disease (chronic dialysis or to be expected)
• Neurological conditions influencing functional status (e.g. spinal cord injury, neuromuscular disease, dementia, prior TBI or stroke)
• No fixed address
• Physician refusal
• Brain death
• Unable to return to the study center to attend the follow-up visits
• Admission to the Intensive Care Unit of the participating center > 24 hours after TBI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pituitary function evaluation	Pituitary function evaluation	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.

Primary Outcome Measures

Name	Time	Method
Adherence to the Protocol	12 months	Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section
Enrollment Rate	12 months	Number of patients recruited per month per site

Secondary Outcome Measures

Name	Time	Method
Secondary hypogonadism	12 months
Growth hormone deficit	12 months
Neurological Recovery	12 months	Glasgow Outcome Scale Extended (GOSe)
Quality of life	12 months	EuroQuol - EQ-5D-5L questionnaire
Independent functioning	12 months	Functional Independence Measure (FIM) questionnaire
Life satisfaction	12 months	Life Satisfaction Questionnaire (LISAT)
Secondary adrenal insufficiency	12 months
Depression	12 months	Patient Health Questionnaire (PHQ-9)
Secondary hypothyroidism	12 months

Trial Locations

Locations (5)

Hôpital du Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

CHU de Québec - Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec, Canada

CHU de Sherbrooke - Hôpital Fleurimont; 🇨🇦 Sherbrooke, Quebec, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada