- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480985
The PIT-TBI Pilot Study
March 24, 2017 updated by: François Lauzier, CHU de Quebec-Universite Laval
Clinical Outcomes and Predictors of PITuitary Disorders in Patients With Moderate and Severe Traumatic Brain Injury: the PIT-TBI Prospective Multicenter Pilot Cohort Study
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Quebec, Canada
- CHU de Quebec - Hopital de l'Enfant-Jésus
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Ontario
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Ottawa, Ontario, Canada
- The Ottawa Hospital
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada
- Hôpital du Sacré-Coeur de Montreal
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Sherbrooke, Quebec, Canada
- CHU de Sherbrooke - Hôpital Fleurimont
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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Pituitary function evaluation performed at hospital discharge, 6 and 12 months
Risk factors evaluation of pituitary dysfunction
Outcome measures at 6 and 12 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the Protocol
Time Frame: 12 months
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Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section
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12 months
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Enrollment Rate
Time Frame: 12 months
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Number of patients recruited per month per site
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological Recovery
Time Frame: 12 months
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Glasgow Outcome Scale Extended (GOSe)
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12 months
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Quality of life
Time Frame: 12 months
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EuroQuol - EQ-5D-5L questionnaire
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12 months
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Independent functioning
Time Frame: 12 months
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Functional Independence Measure (FIM) questionnaire
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12 months
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Depression
Time Frame: 12 months
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Patient Health Questionnaire (PHQ-9)
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12 months
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Life satisfaction
Time Frame: 12 months
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Life Satisfaction Questionnaire (LISAT)
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12 months
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Secondary hypothyroidism
Time Frame: 12 months
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12 months
|
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Secondary hypogonadism
Time Frame: 12 months
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12 months
|
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Secondary adrenal insufficiency
Time Frame: 12 months
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12 months
|
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Growth hormone deficit
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: François Lauzier, MD MSc FRCPC, CHU de Quebec Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
June 18, 2015
First Submitted That Met QC Criteria
June 24, 2015
First Posted (Estimate)
June 25, 2015
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C14-06-2040-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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