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Pituitary DisordersNCT02480985

The PIT-TBI Pilot Study

A study testing Pituitary function evaluation in people with Pituitary Disorders and Traumatic Brain Injury, run by CHU de Quebec-Universite Laval at 5 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pituitary Disorders, Traumatic Brain Injury
What is being tested?
Pituitary function evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
5 sitesCanada
Study dates
Mar 2015to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Hôpital du Sacré-Coeur de Montréal

    Montreal, Quebec

  • The Ottawa Hospital

    Ottawa, Ontario

  • CHU de Québec - Hôpital de l'Enfant-Jésus

    Québec, Quebec

  • CHU de Sherbrooke - Hôpital Fleurimont

    Sherbrooke, Quebec

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

About this study

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

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.

Being tested
Pituitary function evaluation
Keywords
Pituitary Disorders, Traumatic Brain Injury, Critical Care, Outcome Research, Risk Factors, Patient Oriented Research
Medical subject headings
Pituitary Diseases, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pituitary function evaluationOther

    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)
Study groups in NCT02480985
Study groupRoleWhat they receive
Pituitary function evaluationOtherExams 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.
Receives: Other: Pituitary function evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to the Protocol

    Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section

    Measured: 12 months

  2. Enrollment Rate

    Number of patients recruited per month per site

    Measured: 12 months

Secondary outcomes (9)

  1. Neurological Recovery

    Glasgow Outcome Scale Extended (GOSe)

    Measured: 12 months

  2. Quality of life

    EuroQuol - EQ-5D-5L questionnaire

    Measured: 12 months

  3. Independent functioning

    Functional Independence Measure (FIM) questionnaire

    Measured: 12 months

  4. Depression

    Patient Health Questionnaire (PHQ-9)

    Measured: 12 months

  5. Life satisfaction

    Life Satisfaction Questionnaire (LISAT)

    Measured: 12 months

  6. Secondary hypothyroidism

    Measured: 12 months

  7. Secondary hypogonadism

    Measured: 12 months

  8. Secondary adrenal insufficiency

    Measured: 12 months

  9. Growth hormone deficit

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2018 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480985
Sponsor's protocol ID
C14-06-2040-21
Status last verified
Mar 2017
First submitted
18 Jun 2015
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Lauzier F, Turgeon AF, Boutin A, Shemilt M, Cote I, Lachance O, Archambault PM, Lamontagne F, Moore L, Bernard F, Gagnon C, Cook D. Clinical outcomes, predictors, and prevalence of anterior pituitary disorders following traumatic brain injury: a systematic review. Crit Care Med. 2014 Mar;42(3):712-21. doi: 10.1097/CCM.0000000000000046.

    PubMed 24247474

Questions about this trial

What is this clinical trial studying?

A study testing Pituitary function evaluation in people with Pituitary Disorders and Traumatic Brain Injury, run by CHU de Quebec-Universite Laval at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to the Protocol (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

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