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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
      • Quebec, Canada
        • CHU de Quebec - Hopital de l'Enfant-Jesus
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Hopital du Sacre-Coeur de Montreal
      • Sherbrooke, Quebec, Canada
        • CHU de Sherbrooke - Hôpital Fleurimont

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months
Enrollment Rate
Time Frame: 12 months
Number of patients recruited per month per site
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurological Recovery
Time Frame: 12 months
Glasgow Outcome Scale Extended (GOSe)
12 months
Quality of life
Time Frame: 12 months
EuroQuol - EQ-5D-5L questionnaire
12 months
Independent functioning
Time Frame: 12 months
Functional Independence Measure (FIM) questionnaire
12 months
Depression
Time Frame: 12 months
Patient Health Questionnaire (PHQ-9)
12 months
Life satisfaction
Time Frame: 12 months
Life Satisfaction Questionnaire (LISAT)
12 months
Secondary hypothyroidism
Time Frame: 12 months
12 months
Secondary hypogonadism
Time Frame: 12 months
12 months
Secondary adrenal insufficiency
Time Frame: 12 months
12 months
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Quebec-Universite Laval

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Canadian Critical Care Trials Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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