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The PIT-TBI Pilot Study

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ClinicalTrials.gov Identifier: NCT02480985
Recruitment Status : Unknown
Verified March 2017 by François Lauzier, CHU de Quebec-Universite Laval.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
François Lauzier, 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.

Condition or disease Intervention/treatment Phase
Pituitary Disorders Traumatic Brain Injury Other: Pituitary function evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Outcomes and Predictors of PITuitary Disorders in Patients With Moderate and Severe Traumatic Brain Injury: the PIT-TBI Prospective Multicenter Pilot Cohort Study
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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)




Primary Outcome Measures :
  1. Adherence to the Protocol [ Time Frame: 12 months ]
    Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section

  2. Enrollment Rate [ Time Frame: 12 months ]
    Number of patients recruited per month per site


Secondary Outcome Measures :
  1. Neurological Recovery [ Time Frame: 12 months ]
    Glasgow Outcome Scale Extended (GOSe)

  2. Quality of life [ Time Frame: 12 months ]
    EuroQuol - EQ-5D-5L questionnaire

  3. Independent functioning [ Time Frame: 12 months ]
    Functional Independence Measure (FIM) questionnaire

  4. Depression [ Time Frame: 12 months ]
    Patient Health Questionnaire (PHQ-9)

  5. Life satisfaction [ Time Frame: 12 months ]
    Life Satisfaction Questionnaire (LISAT)

  6. Secondary hypothyroidism [ Time Frame: 12 months ]
  7. Secondary hypogonadism [ Time Frame: 12 months ]
  8. Secondary adrenal insufficiency [ Time Frame: 12 months ]
  9. Growth hormone deficit [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480985


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
CHU de Sherbrooke - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Canada
CHU de Québec - Hôpital de l'Enfant-Jésus
Quebec, Canada
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: François Lauzier, MD MSc FRCPC CHU de Quebec Research Center

Additional Information:
Publications:
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Responsible Party: François Lauzier, MD MSc FRCPC, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02480985     History of Changes
Other Study ID Numbers: C14-06-2040-21
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Keywords provided by François Lauzier, CHU de Quebec-Universite Laval:
Pituitary Disorders
Traumatic Brain Injury
Critical Care
Outcome Research
Risk Factors
Patient Oriented Research
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Pituitary Diseases
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hypothalamic Diseases
Endocrine System Diseases